DETAILED ACTION
Primary Examiner acknowledges Claims 1-20 are pending in this application, with Claims 12 and 19 having been currently amended by preliminary amendment on December 22, 2022.
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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “3050-2” has been used to designate “nasal portion” and “mouth portion” (Para 0228). Appropriate correction is required.
Reference character “3920” has been used to designate “first end” and “second end” (Para 0256). Appropriate correction is required.
Reference characters “3380” and “3390” (Para 0390) have been used to designate “anterior engagement portion”. Appropriate correction is required.
Reference characters “3900” and “3925” (Paras 0257, 0258, ) have been used to designate “brace”. Appropriate correction is required.
Reference characters “3050”, “3005” (Para 0255), 3150 (Para 0239) have been used to designate “cushion”. Appropriate correction is required.
Reference characters “3925” and “3920” (Para 0256) have been used to designate “second end”. Appropriate correction is required.
Reference character “3050-1”, “3005-1” and “3050-2” (Para 0228) have been used to designate “mouth portion”. Appropriate correction is required.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Reference character “3050-2” has been used to designate “nasal portion” and “mouth portion” (Para 0228). Appropriate correction is required.
Reference character “3920” has been used to designate “first end” and “second end” (Para 0256). Appropriate correction is required.
Reference characters “3380” and “3390” (Para 0390) have been used to designate “anterior engagement portion”. Appropriate correction is required.
Reference characters “3900” and “3925” (Paras 0257, 0258, ) have been used to designate “brace”. Appropriate correction is required.
Reference characters “3050”, “3005” (Para 0255), 3150 (Para 0239) have been used to designate “cushion”. Appropriate correction is required.
Reference characters “3925” and “3920” (Para 0256) have been used to designate “second end”. Appropriate correction is required.
Reference character “3050-1”, “3005-1” and “3050-2” (Para 0228) have been used to designate “mouth portion”. Appropriate correction is required.
Claim Objections
Claims 2-18 are objected to because of the following informalities:
The preambles of Claims 2-18 do not conform to conventional patent examination practice by the use of the phrase “A patient interface…”; rather, the preambles should read “The patient interface” as each of Claims 2-18 refer back to directly or indirectly to parent Claim 1 which is the first introduction of “A patient interface…”. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, Claim 11 recites the limitation “the recess”; however, there is insufficient antecedent basis for this limitation in the claims. It appears the parentage of Claim 11, should be to Claim 10 instead of Claim 1, as Claim 10 provides the introduction of “a recess”. Appropriate correction and clarification is required.
Specifically, Claim 18 recites the phrase “an otobasion superior of the patient's head” twice at Lines 4 and 5. Primary Examiner is unsure if this is simply a typo or Applicant is attempting to recite some other feature. Consequently, the breadth and scope of this claim limitation is unclear. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 9-12, 17, and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Faulconer (2,749,910), with extrinsic evidence of Stepan et al. (2009/0078266) and Mc Auley et al. (2013/0239972).
As to Claim 1, Faulconer discloses a patient interface (best seen Figures 1-7) for supplying a flow of air (via 25, “The anesthetic supply system generally designated 25 attaches to coupling 24. … Of course, where the device is used for the administration of oxygen or other gases, other supply sources and valving arrangements may be provided at 25.” Column 3, Lines 10-30) at therapeutic pressure to a patient’s airways (covering nose and mouth as seen in Figure 1), the patient interface (Figures 1-7) comprising: a cushion module (defined as the combination of 10 and 24, wherein 10 - “In the exemplary form shown in Figures 1-6, the device consists of a mask portion generally designated 10 which is composed of an outer wall 11 and an inner wall 12 of rubber. Walls 11 and 12 are joined together to form a continuous flexible bulbous edge 16 and are like- wise joined together around the aperture 23. ” Column 2, Lines 15-30, and wherein 24 – “The molding provides a circular orifice at 23 which serves as the place to which coupling 24 may be attached.” Column 3, Lines 10-30) comprising a cushion (16, “a continuous flexible bulbous edge 16” Column 2, Lines 15-30), wherein the cushion (16) is constructed and configured to be substantially flexible (“flexible” Column 2, Lines 15-30); a brace (22, “After closure there is inserted a filling 22 of granular material. This granular material is preferably of granular plastic. Thus, for example, there may be used vinyl plastic granules. These granules are regular vinyl plastic molding powder and are relatively sharp and irregular granules.” Column 3, Lines 1-15), wherein the cushion module (defined as the combination of 10 and 24) at least partially defines a plenum chamber (defined as the interior regions of 10 and 24 which receive the nose and mouth as seen in Figure 1) pressurizable to the therapeutic pressure and comprising a plenum chamber inlet port (24, via 23, “The molding provides a circular orifice at 23 which serves as the place to which coupling 24 may be attached.” Column 3, Lines 10-30) for receiving the flow of air (via 25) into the plenum chamber (defined as the interior regions of 10 and 24 which receive the nose and mouth as seen in Figure 1), wherein the cushion (16) comprises a seal forming structure (via 16A-E, “The portion 16 is integral with the walls 11 and 12, the whole forming a smooth bulbous roll edge which, being of thin it, rubber, is easily deflected. This face contacting portion rises at portion 16A, is shaped so as to bridge the nose of the patient, and then extends along the portion 16B along either side of the nose and thence dips downwardly at 16C where it also widens into a fairly commodious edge portion as at 16E in Figure 5 which contacts around the lower lip of the patient.” Column 2, Lines 35-65) constructed and configured to form a seal with a region of the patient’s face surrounding an entrance to the patient’s nares (best seen Figures 1 and 6), said seal forming structure (via 16A-E) having an opening (bounded by the interior of 16 receiving the nose and mouth as shown in Figure 1) therein such that the flow of air (via 25) at the therapeutic pressure is delivered to the patient’s nares in use, the seal forming structure (via 16A-E) constructed and configured to maintain the therapeutic pressure in the plenum chamber (defined as the interior regions of 10 and 24 which receive the nose and mouth as seen in Figure 1) throughout the patient’s respiratory cycle in use, and wherein the cushion (16) comprises a nasal portion (16A) configured to be positioned, in use, proximate and anterior to the nasal and/or lip superior region of the patient’s face, wherein the cushion module (defined as the combination of 10 and 24) is configured to connect, in use, to a positioning and stabilizing structure (via 72, “Any usual anesthetic supply system 25 may be used and is provided with controls at 71 and anchoring hooks at 72-72.” Column 3, Lines 10-25; also see: “In use the mask is placed on the patient in the position shown in Figure 1. The usual straps or elastic bands are then placed around the patient's head and attached to the hooks 72, thus pressing the mask down firmly against the patient's face.” Column 4, Lines 1-15) to provide a force to hold the seal forming structure (via 16A-E) in a therapeutically effective position the patient’s head, wherein the brace (22) is configured to mount to the nasal portion (16A) of the cushion (16) and in use to brace against movement of portions of the seal forming structure (via 16A-16E) in sealing engagement with regions of the patient’s face proximate the patient’s nares.
Regarding the limitation to “the brace is constructed and configured to be more rigid than the nasal portion of the cushion”, Faulconer discloses the brace is constructed of “granular plastic”; whilst, Faulconer discloses the nasal portion of the cushion is constructed of “rubber”. By convention, one of the manners to ascertain “rigidity” is by comparison of the modulus of the materials, whereby the modulus is a quantitative analysis metric to determine the degree of resistance to bending. As such, the material having the higher number is more resistant to bending and thus more rigid by comparison. Generic plastic has a general modulus of 335 to 13700 MPa; whilst, generic rubber has a general modulus of 10-100 MPa. Clearly generic plastic is a larger number and is thus more resistant to bending and thus more rigid than generic rubber.
Should Applicant respectfully disagree with Primary Examiner’s assertion of generic modulus valuations of plastic and rubber, Primary Examiner presents the with extrinsic evidence of Stepan et al. (2009/0078266) and Mc Auley et al. (2013/0239972), whereby Stepan unequivocally states “The plastic typically exhibits a flexural modulus of about 75 to 300 Mega Pascals (MPa), more typically about 100 to 250 MPa, and still typically about 175 to 225 MPa.” (Para 0050) and whereby Mc Auley unequivocally states “polycarbonate has a Young's modulus of approximately 2 GPa, whereas the Young's modulus of a rubber or other suitable material for use as the flexible seal is in the order of 1 to 5 MPa.” (Para 0155). Thus, clearly rubber has a modulus on the order of 1-5 Mpa, as compared to plastic having a modulus on the order of 75-300 MPa, and polycarbonate having a modulus on the order of 2 GPa.
Thus, the claimed configuration by which the brace made of plastic results in a more rigid construction than that the cushion made of rubber.
As to Claim 2, Faulconer discloses the brace (22) comprises a concave patient facing surface facing toward the patient in use. As best seen in Figures 1-7, the brace (22) is mounted within the cushion (16) to provide conformability of the cushion to the face of the patient. In this construction, the brace (22) at the patient facing surface (17A-17D, as best seen in Figures 3-5) forms a concave surface to receive the nose and mouth of the patient.
As to Claim 3, Faulconer discloses the brace (22) comprises a convex non-patient facing surface away from the patient in use. As best seen in Figures 1-7, the brace (22) is mounted within the cushion (16) to provide conformability of the cushion to the face of the patient. In this construction, the brace (22) at the non-patient facing surface (defined by the exterior perimeters of 16 at 11, best seen Figures 3-5) forms a convex surface which budges outward away from the patient in use.
As to Claim 4, Faulconer discloses the brace (22) is arc-shaped when viewed in a direction perpendicular to the transverse plane of the patient (best seen Figures 3 and 5). As best seen in Figures 1-7, the brace (22) is mounted within the cushion (16) to provide conformability of the cushion to the face of the patient. In this construction, the brace (22) as mounted within the cushion (16) forms an arcuate shape.
As to Claim 5, Faulconer discloses the brace (22) is elongate and the brace (22) is configured to mount to the nasal portion (16A) of the cushion in an orientation such that the brace (22) is elongate in the lateral direction with respect to the patient in use. As best seen in Figures 1-7, the brace (22) is mounted within the cushion (16) to provide conformability of the cushion to the face of the patient. In this construction, the brace (22) extends laterally from the nasal portion (16A) about the entirety of the patient’s face, to include points near the cheeks (16C/17C, as shown in Figures 1, 3, and 4) in an elongated structure which bounds the nose and mouth regions of the patient’s face.
As to Claim 6, Faulconer discloses the brace (22) is mounted to the nasal portion (16A) of the cushion (16), the nasal portion (16A) of the cushion (16) is deformed relative to the natural shape of the nasal portion (16A) of the cushion (16A). As best seen in Figures 1-7, the brace (22) is mounted within the cushion (16) to provide conformability of the cushion to the face of the patient. In this construction, the brace (22) at the nasal portion (16A) is deformed to meet the nasal bridge region (via 17A, best seen Figure 4) of the patient.
As to Claim 9, Faulconer discloses the brace (22) comprises a material (“granular plastic”) having an elastic modulus greater than the respective elastic modulus of the material (“rubber”) of the material of the nasal portion (16A) of the cushion (16) is comprised from. As stated in Claim 1 and reiterated here below for Applicant’s convenience, generic plastic has a general modulus of 335 to 13700 MPA; whilst, generic rubber has a general modulus of 10-100 MPA. Clearly generic plastic is a larger number and is thus more resistant to bending and thus more rigid than generic rubber. Or alternatively, utilizing extrinsic evidence of Stepan et al. (2009/0078266) and Mc Auley et al. (2013/0239972), clearly rubber has a modulus on the order of 1-5 Mpa, as compared to plastic having a modulus on the order of 75-300 MPa, and polycarbonate having a modulus on the order of 2 GPa. Thus, the claimed configuration by which the brace made of plastic has a greater elastic modulus than that the cushion made of rubber, as claimed.
As to Claim 10, Faulconer discloses the nasal portion (16A) of the cushion (16) forms a recess (defined by the interior of 11 and 12, which receives the “granular plastic” of 22) into which the brace (22) is positioned in use.
As to Claim 11, Faulconer discloses the recess (defined by the interior of 11 and 12, which receives the “granular plastic” of 22) is sized so that the brace (22) fits securely with a frictional fit. The concept of “frictional fit” is a function of the admission or removal of the vacuum as described Column 3, Lines 25-60 to impart the condition whereby “pressure is exerted upon the granular filling 22 and the granules then are held in compacted condition as a hard fixed mass which can only be moved or changed by the exertion of considerable force. The entire mask quickly "solidifies" into a hard stiff structure, so long as the vacuum is applied. It relaxes easily into a soft easily pushed and molded mass when the vacuum is released and air admitted at coupling 29.” Thus the admission or removal of the vacuum results in a frictional engagement of the brace as fitted within the recess.
As to Claim 12, Faulconer discloses the seal forming structure (via 16A-E) is constructed and configured to form a seal with a region of the patient’s face surrounding an entrance of the patient’s mouth (via 16C and 16D at 17C and 17D, to engage the cheeks about the mouth and chin of the user as shown in Figure 1) such that the flow of air (via 25) is delivered to the patient’s mouth in use.
As to Claim 17, Faulconer discloses the patient interface (Figures 1-7) comprises the positioning and stabilizing structure (via 72, “Any usual anesthetic supply system 25 may be used and is provided with controls at 71 and anchoring hooks at 72-72.” Column 3, Lines 10-25; also see: “In use the mask is placed on the patient in the position shown in Figure 1. The usual straps or elastic bands are then placed around the patient's head and attached to the hooks 72, thus pressing the mask down firmly against the patient's face.” Column 4, Lines 1-15) to provide a force to hold the seal forming structure (via 16A-16E) in a therapeutically effective position the patient’s head.
As to Claim 20, please see the rejections of Claims 1, 2, 4, and 5, whereby Claim 1 address the generic structure of the patient interface having a brace, Claim 2 addresses the concave patient facing surface, Claim 4 addresses the arc-shaped structure , and Claim 5 addresses the mounted configuration of the brace in an elongated formation about the face of the patient.
Claims 1-6, 9-17, and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Bishop (6,851,429), with extrinsic evidence of Stepan et al. (2009/0078266) and Mc Auley et al. (2013/0239972).
As to Claim 1, Bishop discloses a patient interface (Figures 1-5) for supplying a flow of air (via 22, “At this point 20, the canopy member 2 has a gas port opening 21 provided by an outwardly-projecting coupling 22 shaped to receive a cooperating coupling 23 at the end of ventilation tubing 24.” Column 2, Lines 15-35) at a therapeutic pressure to the patient’s airways (Figures 1-4: nose and mouth, Figure 5: nose only), the patient interface (Figures 1-5) comprising: a cushion module (defined as the combination of 1 and 2, “With reference to FIGS. 1 to 4, the face mask comprises two separate parts that can be connected or disconnected as desired, namely a ring member 1 and a canopy member 2.” Column 1, Line 60-70) comprises a cushion (11, “The ring member 1 is relatively shallow and comprises a relatively soft, bendable plastics frame 10 of substantially triangular section supporting an adhesive flange 11 on its lower surface. The flange 11 is made of a soft, putty-like gel material that sets to a rubbery consistency when exposed to air.” Column 2, Lines 1-20) is constructed and configured to be substantially flexible (“rubbery consistency”); and a brace (10, “The ring member 1 is relatively shallow and comprises a relatively soft, bendable plastics frame 10 of substantially triangular section supporting an adhesive flange 11 on its lower surface. ” Column 2, Lines 1-20), wherein the cushion module (defined as the combination of 1 and 2) at least partially defines a plenum chamber (defined by the interior of 1 and 2, encompassing the nose and/or mouth of the patient as shown in Figures 2/3 and/or 5) pressurizable to the therapeutic pressure and comprising a plenum chamber inlet port (21, “a gas port opening 21” Column 2, Lines 15-35) for receiving the flow of air (via 22) into the plenum chamber (defined by the interior of 1 and 2, encompassing the nose and/or mouth of the patient as shown in Figures 2/3 and/or 5), wherein the cushion (11) comprises a seal forming structure (via “adhesive” as applied to 11, Column 2, Lines 1-20; also see: “After a short period of time the adhesive 11 cures to a rubbery consistency forming an effective mechanical bond and gas-tight seal with the skin.” Column 2, Lines 30-50) constructed and configured to form a seal with a region of the patient’s face surrounding an entrance to the patient’s nares (Figures 1-4: nose and mouth, Figure 5: nose only), said seal forming structure (via “adhesive” as applied to 11) having an opening therein (defined by the interior perimeter of 1, which engages the nose and/or mouth of the patient, as shown in Figures 1-5) such that the flow of air (via 22) at the therapeutic pressure is delivered to the patient’s nares in use, the seal forming structure (via “adhesive” as applied to 11) constructed and configured to maintain the therapeutic pressure in the plenum chamber (defined by the interior of 1 and 2, encompassing the nose and/or mouth of the patient as shown in Figures 2/3 and/or 5) throughout the patient’s respiratory cycle in use, and wherein the cushion (11) comprises a nasal portion (defined by 11 nearest 4, as shown in Figures 2 and 5) configured to be positioned in use proximate and anterior to the nasal and/or lip superior region of the patient’s face, wherein the cushion module (defined as the combination of 1 and 2) is configured to connect in use to a positioning and stabilizing structure (“adhesive” as cured and attached to the skin) to provide a force to hold the seal forming structure (via “adhesive” as applied to 11) in a therapeutically effective position on the patient’s head, wherein the brace (10) is configured to mount to the nasal portion (defined by 11 nearest 4) of the cushion (11) and in use to brace against the movement of portions of the seal forming structure (via “adhesive” as applied to 11) in sealing engagement with regions of the patient’s face proximate the patient’s nares.
Regarding the limitation to “the brace is constructed and configured to be more rigid than the nasal portion of the cushion”, Bishop discloses the brace is constructed of “a relatively soft, bendable plastics frame 10”; whilst, Bishop discloses the nasal portion of the cushion is constructed of “a soft, putty-like gel material that sets to a rubbery consistency”. By convention, one of the manners to ascertain “rigidity” is by comparison of the modulus of the materials, whereby the modulus is a quantitative analysis metric to determine the degree of resistance to bending. As such, the material having the higher number is more resistant to bending and thus more rigid by comparison. Generic plastic has a general modulus of 335 to 13700 MPA; whilst, generic rubber has a general modulus of 10-100 MPA. Clearly generic plastic is a larger number and is thus more resistant to bending and thus more rigid than generic rubber.
Should Applicant respectfully disagree with Primary Examiner’s assertion of generic modulus valuations of plastic and rubber, Primary Examiner presents the with extrinsic evidence of Stepan et al. (2009/0078266) and Mc Auley et al. (2013/0239972), whereby Stepan unequivocally states “The plastic typically exhibits a flexural modulus of about 75 to 300 Mega Pascals (MPa), more typically about 100 to 250 MPa, and still typically about 175 to 225 MPa.” (Para 0050) and whereby Mc Auley unequivocally states “polycarbonate has a Young's modulus of approximately 2 GPa, whereas the Young's modulus of a rubber or other suitable material for use as the flexible seal is in the order of 1 to 5 MPa.” (Para 0155). Thus, clearly rubber has a modulus on the order of 1-5 Mpa, as compared to plastic having a modulus on the order of 75-300 MPa, and polycarbonate having a modulus on the order of 2 GPa.
Thus, the claimed configuration by which the brace made of plastic results in a more rigid construction than that the cushion made of rubber.
As to Claim 2, Bishop discloses the brace (10) a comprises a concave patient facing surface facing toward the patient in use. As best seen in Figure 4, the brace (10) is mounted to the cushion (11) and includes a concave surface (via 13, “The flange 11 is retained with the frame 10 by means of key and key-way shape formations 12 and 13 (FIG. 4) around the lower edge of the frame so that the flange material fills the key-ways to resist removal.” Column 2, Lines 1-20) which face the patient during use.
As to Claim 3, Bishop discloses the brace (10) comprises a convex non-patient facing surface facing away from the patient in use. As best seen in Figure 4, the brace (10) is mounted to the cushion (11) and includes a convex surface (proximate 15, “The upper end of the frame 10 has a recess or channel 15 formed around the ring member 1, the channel having a laterally enlarged portion 16 at its lower end.” Column 2, Lines 1-20) which faces away from the patient in use.
As to Claim 4, Bishop discloses the brace (10) is arc-shaped when viewed in a direction perpendicular to the transverse plane of the patient. . As best seen in Figure 4, the brace (10) is mounted to the cushion (11) and has arc-shaped structures (12 and 16, wherein 12 - “The flange 11 is retained with the frame 10 by means of key and key-way shape formations 12 and 13 (FIG. 4) around the lower edge of the frame so that the flange material fills the key-ways to resist removal.” Column 2, Lines 1-20; and wherein 16 - “The upper end of the frame 10 has a recess or channel 15 formed around the ring member 1, the channel having a laterally enlarged portion 16 at its lower end.” Column 2, Lines 1-20).
As to Claim 5, Bishop discloses the brace (10) is elongate and the brace (10) is configured to mount to the nasal portion (defined by 11 nearest 4) of the cushion (11) in an orientation such that the brace (10) is elongate in a lateral direction with respect to the patient in use. As best seen in Figures 2 and 5, the orientation of the brace (10) extends laterally to at least the sides of the nose – Figure 5; and further along the mouth of the patient – Figure 2).
As to Claim 6, Bishop discloses the brace (10) is mounted to the nasal portion (defined by 11 nearest 4) of the cushion (11), the nasal portion (defined by 11 nearest 4) of the cushion (11) is deformed relative to the natural shape of the nasal portion (defined by 11 nearest 4) of the cushion (11). As addressed Bishop states “the ring 1 resumes its natural shape with any variations in contour between the skin surface and the lower surface of the ring being accommodated by deformation of the adhesive or the skin.” (Column 2, Lines 30-50).
As to Claim 9, Bishop discloses the brace is constructed of “a relatively soft, bendable plastics frame 10”; whilst, Bishop discloses the nasal portion of the cushion is constructed of “a soft, putty-like gel material that sets to a rubbery consistency”. As stated in Claim 1 and reiterated here below for Applicant’s convenience, generic plastic has a general modulus of 335 to 13700 MPA; whilst, generic rubber has a general modulus of 10-100 MPA. Clearly generic plastic is a larger number and is thus more resistant to bending and thus more rigid than generic rubber. Or alternatively, utilizing extrinsic evidence of Stepan et al. (2009/0078266) and Mc Auley et al. (2013/0239972), clearly rubber has a modulus on the order of 1-5 Mpa, as compared to plastic having a modulus on the order of 75-300 MPa, and polycarbonate having a modulus on the order of 2 GPa. Thus, the claimed configuration by which the brace made of plastic has a greater elastic modulus than that the cushion made of rubber, as claimed.
As to Claim 10, Bishop discloses the nasal portion (defined by 11 nearest 4) forms a recess (best seen Figure 4, via interaction of 12 and 13, “means of key and key-way shape formations 12 and 13 (FIG. 4)” Column 2, Lines 1-20) into which the brace (10) is positioned in use.
As to Claim 11, Bishop discloses the recess (best seen Figure 4, via interaction of 12 and 13, “means of key and key-way shape formations 12 and 13 (FIG. 4)” Column 2, Lines 1-20) is sized so that the brace (10) fits securely with a friction fit (“The flange 11 is retained with the frame 10 by means of key and key-way shape formations 12 and 13 (FIG. 4) around the lower edge of the frame so that the flange material fills the key-ways to resist removal.” Column 2, Lines 1-20).
As to Claim 12, Bishop discloses the seal forming structure (via “adhesive” as applied to 11) is constructed and configured to form a seal with a region of the patient’s face surrounding an entrance to the patient’s mouth (best seen Figures 2 and 3) such that the flow of air (via 22) is delivered to the patient’s mouth in use.
As to Claim 13, Bishop discloses the cushion module (defined as the combination of 1 and 2) comprises a frame (2, “The canopy member 2 is of a relatively stiff, transparent plastics material and is shaped like a conventional face mask with a generally oval, domed surface the highest point 20 of which is displaced towards the end of the canopy closer the mouth 3” Column 2, Lines 15-35), wherein the frame (2) is constructed and configured to be more rigid than the nasal portion (defined by 11 nearest 4) of the cushion (11). As stated in Claim 1 and reiterated here below for Applicant’s convenience, generic plastic has a general modulus of 335 to 13700 MPA; whilst, generic rubber has a general modulus of 10-100 MPA. Clearly generic plastic is a larger number and is thus more resistant to bending and thus more rigid than generic rubber. Or alternatively, utilizing extrinsic evidence of Stepan et al. (2009/0078266) and Mc Auley et al. (2013/0239972), clearly rubber has a modulus on the order of 1-5 Mpa, as compared to plastic having a modulus on the order of 75-300 MPa, and polycarbonate having a modulus on the order of 2 GPa. Thus, the claimed configuration by which the frame made of plastic results in a more rigid construction than that the cushion made of rubber.
As to Claim 14, Bishop discloses the frame (2) at least in part defines the plenum chamber (defined by the interior of 1 and 2).
As to Claim 15, Bishop discloses the frame (2) comprises an frame opening (defined by the interior diameter of 21, “At this point 20, the canopy member 2 has a gas port opening 21 provided by an outwardly-projecting coupling 22 shaped to receive a cooperating coupling 23 at the end of ventilation tubing 24.” Column 2, Lines 15-35) forming the plenum chamber inlet port (21, “a gas port opening 21” Column 2, Lines 15-35).
As to Claim 16, Bishop discloses the frame opening (defined by the interior diameter of 21) is positioned in an anterior central region of the patient interface (Figures 1-5) when worn.
As to Claim 17, Bishop discloses the positioning and stabilizing structure (“adhesive” as cured and attached to the skin) to provide a force to hold the seal forming structure (via “adhesive” as applied to 11) in a therapeutically effective position on the patient’s head.
As to Claim 20, please see the rejections of Claims 1, 2, 4, and 5, whereby Claim 1 address the generic structure of the patient interface having a brace, Claim 2 addresses the concave patient facing surface, Claim 4 addresses the arc-shaped structure , and Claim 5 addresses the mounted configuration of the brace in an elongated formation about the face of the patient.
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.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Bishop (6,851,429) in view of Ho et al. (2007/0125385).
As to Claim 7, Bishop discloses the brace (10) is mounted to the nasal portion (defined by 11 nearest 4) of the cushion (11); yet, does not expressly disclose the orientation of the brace having a cross sectional shape that is substantially rectangular.
Ho teaches an alternative patient interface (best seen Figures 1-5) for supplying a flow of air (via 120, “pressure generating device 120” Paras 0056 and 0057) at a therapeutic pressure (“CPAP” Para 0057) to a patient’s airways (nose and mouth), the patient interface (best seen Figures 1-5) comprising: a cushion module (defined by the combination of 112 and 114, “Patient interface 110 includes a faceplate 112 and a seal member 114 attached to faceplate 112 for contacting the user's face.” Para 0056) comprising a cushion (114, “seal member 114”), wherein the cushion (114) is constructed and configured to be substantially flexible ( “Seal member 114 is preferably formed from a flexible material such as silicone.” Para 0061); and a brace (136, “To mount seal member 114 to faceplate 112, oral cushion portion 122 is coupled to a two-piece base or mounting ring 136, 138. Two-piece base or mounting ring 136, 138 is formed from an upper mounting portion 136 and a lower mounting portion 138 each having snapping members 140 in the form round hooks (as shown in FIGS. 4 and 5).” Para 0065; also see: “In addition, the mounting ring can be made from any suitable material, such as plastic.” Para 0079), wherein the cushion module (defined by the combination of 112 and 114) at least in part defines a plenum chamber (defined by the interior perimeters of 112 and 114, which receive the nose and mouth of the patient) pressurizable to the therapeutic pressure (“CPAP”) and comprising a plenum chamber inlet port (117, “An opening 117 is provided in the faceplate to communicate a flow of gas between a chamber 119 defined in the patient interface and conduit 116.” Para 0056) for receiving the flow of air (via 120) into the plenum chamber (defined by the interior perimeters of 112 and 114), the cushion (114) comprises a seal forming structure (160, “nasal interface portion 124 is formed from a flexible peripheral wall 154, which has a base 156 integral with cushion flap portion 122 and an outer contoured portion 158. Extending from outer contoured portion 158 is an in-turned surface 160 for contacting the user's nose.” Para 0070) constructed and configured to form a seal with a region of the patient’s face surrounding an entrance to the patient’s nares, the seal forming structure (160) having an opening therein (bounded by the interior walls 154, as best seen in Figure 3) such that the flow of air (via 120) at the therapeutic pressure (“CPAP”) is delivered to the patient’s nares in use, the seal forming structure (160) constructed and arranged to maintain the therapeutic pressure (“CPAP”) throughout the patient’s respiratory cycle in use, and wherein the cushion (114) comprises a nasal portion (124, “nasal interface portion 124 is formed from a flexible peripheral wall 154, which has a base 156 integral with cushion flap portion 122 and an outer contoured portion 158. Extending from outer contoured portion 158 is an in-turned surface 160 for contacting the user's nose.” Para 0070) configured to be positioned in use, proximate and anterior to a nasal and/or lip superior region of the patient’s face, wherein the cushion module (defined by the combination of 112 and 114) is configured to connect in use to a positioning and stabilizing structure (via 174, “To attach the headgear straps to faceplate 112, attachment rails 174 provided on each end of the faceplate. Each attachment rail includes multiple position slots 176 for receiving a stem of a headgear attachment clip (see headgear clip 914 in FIG. 27) attached to a headgear straps.” Para 0074) to provide a force to hold the seal forming structure (160) in a therapeutically effective position on the patient’s head, wherein the brace (136) is configured to mount to the nasal portion (124) of the cushion (114) and in use to brace against movement of portions of the seal forming structure (160) in sealing engagement with regions of the patient’s face proximate the patient’s nares.
Regarding the remaining limitations of the claims, Ho teaches the orientation of the brace (136) having a cross sectional shape (best seen Figures 4 and 5) having a substantially rectangular shape to support the engagement of the cushion module in the nasal portion so that the cushion and the frame are mounted together (Para 0079). Furthermore, Ho expressly states consideration to the brace being constructed of a single piece as an alternative to its “two piece mounting ring” (Para 0079), but emphasizes the “two piece mounting” construction provided location specific support to each of the nasal cushion portion and the oral cushion portion to effectively mount the cushion to the frame (Paras 0065 and 0066).
In light of the considerations of Ho, the decision to modify the brace of Bishop form a single piece structure to a two piece brace having specific support for each of the nasal cushion portion and the oral cushion portion would be obvious to try choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, whereby success would be defined by the ability to provide the desired support to each of the nasal and oral portions of the cushion respectively.
Therefore, it would have been obvious to modify the brace of Bishop to include the rectangular cross section as shown in Ho, would have been obvious to one having ordinary skill in the art in order to provide a functionally alternative construction of the brace suitable for imparting desired support to each of the nasal and oral portions of the cushion respectively.
As to Claim 8, Bishop discloses the brace (10) is mounted to the nasal portion (defined by 11 nearest 4) of the cushion (11); yet, does not expressly disclose the orientation of the brace having an arc-shaped rectangular prism.
Ho teaches an alternative patient interface (best seen Figures 1-5) for supplying a flow of air (via 120, “pressure generating device 120” Paras 0056 and 0057) at a therapeutic pressure (“CPAP” Para 0057) to a patient’s airways (nose and mouth), the patient interface (best seen Figures 1-5) comprising: a cushion module (defined by the combination of 112 and 114, “Patient interface 110 includes a faceplate 112 and a seal member 114 attached to faceplate 112 for contacting the user's face.” Para 0056) comprising a cushion (114, “seal member 114”), wherein the cushion (114) is constructed and configured to be substantially flexible ( “Seal member 114 is preferably formed from a flexible material such as silicone.” Para 0061); and a brace (136, “To mount seal member 114 to faceplate 112, oral cushion portion 122 is coupled to a two-piece base or mounting ring 136, 138. Two-piece base or mounting ring 136, 138 is formed from an upper mounting portion 136 and a lower mounting portion 138 each having snapping members 140 in the form round hooks (as shown in FIGS. 4 and 5).” Para 0065; also see: “In addition, the mounting ring can be made from any suitable material, such as plastic.” Para 0079), wherein the cushion module (defined by the combination of 112 and 114) at least in part defines a plenum chamber (defined by the interior perimeters of 112 and 114, which receive the nose and mouth of the patient) pressurizable to the therapeutic pressure (“CPAP”) and comprising a plenum chamber inlet port (117, “An opening 117 is provided in the faceplate to communicate a flow of gas between a chamber 119 defined in the patient interface and conduit 116.” Para 0056) for receiving the flow of air (via 120) into the plenum chamber (defined by the interior perimeters of 112 and 114), the cushion (114) comprises a seal forming structure (160, “nasal interface portion 124 is formed from a flexible peripheral wall 154, which has a base 156 integral with cushion flap portion 122 and an outer contoured portion 158. Extending from outer contoured portion 158 is an in-turned surface 160 for contacting the user's nose.” Para 0070) constructed and configured to form a seal with a region of the patient’s face surrounding an entrance to the patient’s nares, the seal forming structure (160) having an opening therein (bounded by the interior walls 154, as best seen in Figure 3) such that the flow of air (via 120) at the therapeutic pressure (“CPAP”) is delivered to the patient’s nares in use, the seal forming structure (160) constructed and arranged to maintain the therapeutic pressure (“CPAP”) throughout the patient’s respiratory cycle in use, and wherein the cushion (114) comprises a nasal portion (124, “nasal interface portion 124 is formed from a flexible peripheral wall 154, which has a base 156 integral with cushion flap portion 122 and an outer contoured portion 158. Extending from outer contoured portion 158 is an in-turned surface 160 for contacting the user's nose.” Para 0070) configured to be positioned in use, proximate and anterior to a nasal and/or lip superior region of the patient’s face, wherein the cushion module (defined by the combination of 112 and 114) is configured to connect in use to a positioning and stabilizing structure (via 174, “To attach the headgear straps to faceplate 112, attachment rails 174 provided on each end of the faceplate. Each attachment rail includes multiple position slots 176 for receiving a stem of a headgear attachment clip (see headgear clip 914 in FIG. 27) attached to a headgear straps.” Para 0074) to provide a force to hold the seal forming structure (160) in a therapeutically effective position on the patient’s head, wherein the brace (136) is configured to mount to the nasal portion (124) of the cushion (114) and in use to brace against movement of portions of the seal forming structure (160) in sealing engagement with regions of the patient’s face proximate the patient’s nares.
Regarding the remaining limitations of the claims, Ho teaches the orientation of the brace (136) having an arc shaped rectangular prism (best seen Figures 4 and 5) to support the engagement of the cushion module in the nasal portion so that the cushion and the frame are mounted together (Para 0079). Furthermore, Ho expressly states consideration to the brace being constructed of a single piece as an alternative to its “two piece mounting ring” (Para 0079), but emphasizes the “two piece mounting” construction provided location specific support to each of the nasal cushion portion and the oral cushion portion to effectively mount the cushion to the frame (Paras 0065 and 0066).
In light of the considerations of Ho, the decision to modify the brace of Bishop form a single piece structure to a two piece brace having specific support for each of the nasal cushion portion and the oral cushion portion would be obvious to try choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, whereby success would be defined by the ability to provide the desired support to each of the nasal and oral portions of the cushion respectively.
Therefore, it would have been obvious to modify the brace of Bishop to include the arc shaped rectangular prism as shown in Ho, would have been obvious to one having ordinary skill in the art in order to provide a functionally alternative construction of the brace suitable for imparting desired support to each of the nasal and oral portions of the cushion respectively.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over by Faulconer (2,749,910) in view of Bell et al. (2022/0152334).
As to Claim 18, Faulconer discloses the patient interface (Figures 1-7) comprises the positioning and stabilizing structure (via 72, “Any usual anesthetic supply system 25 may be used and is provided with controls at 71 and anchoring hooks at 72-72.” Column 3, Lines 10-25; also see: “In use the mask is placed on the patient in the position shown in Figure 1. The usual straps or elastic bands are then placed around the patient's head and attached to the hooks 72, thus pressing the mask down firmly against the patient's face.” Column 4, Lines 1-15) to provide a force to hold the seal forming structure (via 16A-16E) in a therapeutically effective position the patient’s head, wherein the positioning and stabilizing structure (via 72) is supported with the conduit to convey the flow of air (via 25) to the patient.
Yet, Faulconer does not expressly disclose “the positioning and stabilising structure comprises one or more tubes configured to convey the flow of air at the therapeutic pressure from a connection port to the plenum chamber inlet port, wherein the connection port is positioned, in use, in a region of the patient's head superior to an otobasion superior of the patient's head an otobasion superior of the patient's head.”
Bell teaches an alternative patient interface device (Figures 1A, 1B, and 2) including the combined construction of the positioning and stabilizing structure (32, “Referring to FIGS. 1B and 1C, rear strap 32 includes a central strap portion 33 disposed between two end portions 38. Each end portion 38 is structured to engage and be selectively fastened to one of tubular portions 14, such as via one of mounting tabs 34.” Para 0051; also see: “As shown in FIGS. 1A-1C, support assembly 30 includes a rear strap 32 coupled to left and right side arms 22, 24 which also encircles, or partially encircles, the head of patient 1.” Para 0050) supported with the conduit (8 including 14, best seen Figure 2, “Referring again to FIG. 1A, in order to help secure patient interface device 10 and tubing assembly 8 to the head of patient 1, tubing assembly 8 may further include a support assembly 30.” Para 0050; also see: “Continuing to refer to FIGS. 1A and 1B, as well as FIG. 2, tubing assembly 8 includes a number of tubular portions 14 which each extend from a manifold portion 20 to a distal end 16.” Para 0046) to convey the flow of air (4, best seen Figures 1A, 1B, and 2, “Referring to FIGS. 1A and 1B, respiratory interface system 2 includes a pressure generating device 4 (shown schematically), a delivery conduit 6 fluidly coupled to a tubing assembly 8, and a patient interface device 10 fluidly coupled to tubing assembly 8.” Para 0044) to the patient.
Bell teaches the positioning and stabilizing structure (32) includes one or more tubes (14) configured to convey the flow of air (4, best seen Figures 1A, 1B, and 2) at the therapeutic pressure from a connection port (20, “As shown in FIG. 1A, when tubing assembly 8 is disposed on the head of patient 1, manifold portion 20 is disposed generally at the top of the head of patient 1 and tubular portions 14 extend generally downward from manifold portion 20 to sealing element 12 of patient interface device 10.” Para 0047) to the plenum chamber inlet port (11, best seen Figures 16A-16B, “Each adjustment member 80 includes a protruding portion 82 extending from a first end of body 81, which is of similar form as distal end 16 of tubular portion 14, and a receptacle portion 84 defined in an opposite end of body 81, which is of similar form as an end portion 11 of patient interface device 10. Accordingly, each protruding portion 82 may readily be snap fit (or conversely unsnapped) from one of receptacle portions 84 in a manner like fitting end 16 to end 11 od patient interface device 10.” Para 0066), wherein the connection port (20) is positioned in use in a region of the patient’s head superior to an otobasion superior to the patient’s head.
The resultant effect of the orientation of the tubes at the head of the patient result in the location of the conduit which does not readily restrict the movement of the patient whether laying down or walking around. Hence, this specific placement of the tubes at the head of the patient would be obvious to try choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, whereby success would be defined by the ability to retain the ability of the patient interface to be supported on the head of the patient and conveying the flow of air to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the orientation of the positioning and stabilizing structure of Faulconer to include the specific orientation a top the head of the patient as taught by Bell to be an alternative construction suitable for retain the ability of the patient interface to be supported on the head of the patient and conveying the flow of air to the patient, whereby the orientation a top the head rather than in front of the face is less restrictive to the movement of the patient.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Bishop (6,851,429) in view of Thomlinson et al. (2005/0011524).
As to Claim 19, please see the rejection of Claim 1, whereby Bishop discloses a singular brace (10); yet, does not expressly disclose “at least one additional brace constructed and configured to be more rigid than the nasal portion of the cushion; wherein the additional brace is configured to mount to the nasal portion of the cushion and, in use, to brace against movement of portions of the seal-forming structure in sealing engagement with regions of the patient's face proximate the patient's nares; wherein the brace and the additional brace may be interchangeably mounted to the cushion module; and wherein the brace and the additional brace are shaped and/or sized differently from each other.”
Thomlinson teaches a patient interface having a “pair of interchangeable” components (Para 0006), constructed with “different sizes [that] may be interchanged with other” components (Para 0255; also see: Para 0262 for discussion of “small” vs” extra small”), and additionally constructed by “different size and/or shape” whereby the “using different sized or shaped” components “provides the advantage of enhanced sealing and comfort” when the component is utilized by the patient (Para 0267).
In light of the teachings of Thomlinson as modifying Bishop, the ability to utilize different sized/shaped braces would enable the brace of Bishop to be properly fitted to the specific demographics and anatomy of the patient, as some patients have smaller noses (child/neonate) vs. a bigger nose (adult), as well as different shaped noses flat vs. rounded vs pointed.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the brace of Bishop to be constructed utilizing an interchangeable brace of varying size and/or shape to be selected from to best meet the particular demographics and anatomy of the patient, as taught by Thomlinson to enhance sealing engagement of the patient interface and comfort to the patient utilizing the patient interface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bennett (2,540,567) and Davis (4,665,570) each disclose brace structures retained within an inflatable bladder of a cushion, wherein the brace has a material composition which is different from the material utilized in the inflatable bladder. Yet, these aforementioned references differ from the instantly disclosed invention as the removal of the brace from the inflatable bladder of the cushion requires a destruction of the inflatable bladder.
Mc Auley et al. (2008/0041388) and Lang et al. (2005/0199239) each disclose brace structures retained within a cushion, wherein the brace material is removable from the cushion without destruction of the cushion. Yet, these aforementioned references differ from the instantly disclosed invention as it is unclear whether the brace material composition is more rigid than the cushion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra D 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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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/ Primary Examiner, Art Unit 3785