DETAILED ACTION
This Office Action is in response to the amendment, filed on October 2, 2025. Primary Examiner acknowledges Claims 1, 4, 6, 7, 11, 13, 15-17, 26-33, 35, and 36 are pending in this application, with Claims 1, 15, 17, 27, 32, and 35 having been currently amended, Claim 36 having been newly added, and Claims 2, 3, 5, 8-10, 12, 14, 18-25, and 34 having been cancelled.
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 .
Specification
The disclosure is objected to because of the following informalities: The amended specification, filed on October 2, 2025 does not include the conventional headings. Appropriate correction is required.
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
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 13 and 35 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 13, Line 3 recites the term “the base corners”; however, this limitation appears to lack antecedent basis in the claims, as the term “a base corners” was not previously introduced within the parentage of Claim 13. It appears perhaps the dependency of Claim 13 should include Claim 7, which is the first instance of the term “at base corners”. Appropriate correction and clarification is required.
Specifically, Claim 35, Line 1 recites “according to Claim 34”; however, the breadth and scope of this limitation is unclear, when Claim 34 is cancelled. For purposes of this rejection in the interest of compact prosecution, Primary Examiner will presume the dependency of Claim 35 includes Claim 32. However, 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 27-32, 35, and 36 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by McAuley et al. (2010/0006101).
As to Claim 27, McAuley discloses a sealing cushion (best seen Figures 8 and 9) for a respiratory mask assembly (as shown in Figure 7), the sealing cushion (best seen Figures 8 and 9) comprising a patient interface portion (best seen Figure 8) having a resilient deformable sealing membrane (defined by the combination of 2004 and 2000, “The outer sheath 2004 contacts the inner cushion 2000 throughout the raised bridge 2002.” Para 0101) for engagement with a patient’s face, and an aperture (defined by the central opening in the combination of 2004 and 2000) formed therein for receiving a nasal and/or mouth region of a patient’s face, the sealing membrane (defined by the combination of 2004 and 2000) comprising a plurality of regions of different thicknesses (best seen Figure 9), wherein the thickness of the region is defined as the depth of the sealing membrane (defined by the combination of 2004 and 2000) in that region, the plurality of regions comprising: a compliant nasal region (2002, “In the second embodiment the inner cushion 2000 includes a raised bridge 2002 in the nasal bridge region.” Para 0101) for engagement with the patient’s nasal bridge, nasal support regions (2009, “The peaks 2005, 2007, 2009, 2011 in the inner cushion 2000 between each of the indented sections 2006, 2008 and the raised bridge 2002 contact the outer sheath 2004 and when in use the sheath 2004 contacts the facial contours of the patient in the regions of these peaks.” Para 0101) disposed either side of the compliant nasal region (2002) for engagement with the sides of the patient’s nose, cheek support regions (2006, “The peaks 2005, 2007, 2009, 2011 in the inner cushion 2000 between each of the indented sections 2006, 2008 and the raised bridge 2002 contact the outer sheath 2004 and when in use the sheath 2004 contacts the facial contours of the patient in the regions of these peaks.” Para 0101; also see: “Referring particularly to FIG. 10 the inner cushion 2000 includes a cheek contour 2006 to follow the cartilage extending from the middle of the nose, and a contoured lip scaling portion 2008 to seal between the base of the nose and the upper lip.” Para 0102) extending from each nasal support region (2009) for engagement with at least the patient’s cheeks, and a compliant base region (2008, “The peaks 2005, 2007, 2009, 2011 in the inner cushion 2000 between each of the indented sections 2006, 2008 and the raised bridge 2002 contact the outer sheath 2004 and when in use the sheath 2004 contacts the facial contours of the patient in the regions of these peaks.” Para 0101) extending between the cheek support regions (2006), wherein the sealing membrane (defined by the combination of 2004 and 2000) in the nasal support regions (2009) has a greater thickness than in the cheek support regions (2006), and wherein the sealing membrane (defined by the combination of 2004 and 2000) in the compliant nasal region (2002) and the complaint base region (2008) has a thickness that is less than in the cheek support region (2006) and the nasal support regions (2009), and wherein the sealing membrane (defined by the combination of 2004 and 2000) further comprises a complaint inner member (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6) positioned at the boundary of the patient interface portion and extending substantially around all of the perimeter of the aperture.
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As to Claim 28, McAuley discloses the complaint inner member (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6) has substantially the same width over the majority of the perimeter.
As to Claim 29, McAuley discloses at least a portion of each nasal support region (2009) extends from the complaint inner member (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6) of the patient interface portion across a sidewall portion (via 1114, best shown in Figure 4) extending between the mask connection interface (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6, whereby the as seen in Figure 4, the compliant inner membrane embraces the sidewall of the mask body 2102, as seen in Figure 7, and similarly shown in cross section as 1102 of Figure 4).
As to Claim 30, McAuley discloses the complaint base region (2008) extends from the complaint inner member (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6) across the sidewall portion (via 1114, best shown in Figure 4) to the mask connection interface (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6, whereby the as seen in Figure 4, the compliant inner membrane embraces the sidewall of the mask body 2102, as seen in Figure 7, and similarly shown in cross section as 1102 of Figure 4).
As to Claim 31, McAuley discloses the sidewall portion (via 1114, best shown in Figure 4) comprises reinforced sidewall regions (defined by the shelfs at 1156 and the lateral extension proximate the gas inlet, as best seen in Figure 4 to support the sealing cushion) and the cheek support regions (2006) extend between the complaint inner member (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6) and the reinforced sidewall regions (defined by the shelfs at 1156 and the lateral extension proximate the gas inlet, as best seen in Figure 4 to support the sealing cushion).
As to Claim 32, McAuley discloses a sealing cushion (best seen Figures 8 and 9) for a respiratory mask assembly (as shown in Figure 7), the sealing cushion (best seen Figures 8 and 9) comprising a patient interface portion (best seen Figure 8) having a resilient deformable sealing membrane (defined by the combination of 2004 and 2000, “The outer sheath 2004 contacts the inner cushion 2000 throughout the raised bridge 2002.” Para 0101) for engagement with a patient’s face, and an aperture (defined by the central opening in the combination of 2004 and 2000) formed therein for receiving a nasal and/or mouth region of a patient’s face, the sealing membrane (defined by the combination of 2004 and 2000) comprising a plurality of regions of different thicknesses (best seen Figure 9), wherein the thickness of the region is defined as the depth of the sealing membrane (defined by the combination of 2004 and 2000) in that region, the plurality of regions comprising: a compliant nasal region (2002, “In the second embodiment the inner cushion 2000 includes a raised bridge 2002 in the nasal bridge region.” Para 0101) for engagement with the patient’s nasal bridge, nasal support regions (2009, “The peaks 2005, 2007, 2009, 2011 in the inner cushion 2000 between each of the indented sections 2006, 2008 and the raised bridge 2002 contact the outer sheath 2004 and when in use the sheath 2004 contacts the facial contours of the patient in the regions of these peaks.” Para 0101) disposed either side of the compliant nasal region (2002) for engagement with the sides of the patient’s nose, cheek support regions (2006, “The peaks 2005, 2007, 2009, 2011 in the inner cushion 2000 between each of the indented sections 2006, 2008 and the raised bridge 2002 contact the outer sheath 2004 and when in use the sheath 2004 contacts the facial contours of the patient in the regions of these peaks.” Para 0101; also see: “Referring particularly to FIG. 10 the inner cushion 2000 includes a cheek contour 2006 to follow the cartilage extending from the middle of the nose, and a contoured lip scaling portion 2008 to seal between the base of the nose and the upper lip.” Para 0102) extending from each nasal support region (2009) for engagement with at least the patient’s cheeks, and a compliant base region (2008, “The peaks 2005, 2007, 2009, 2011 in the inner cushion 2000 between each of the indented sections 2006, 2008 and the raised bridge 2002 contact the outer sheath 2004 and when in use the sheath 2004 contacts the facial contours of the patient in the regions of these peaks.” Para 0101) extending between the cheek support regions (2006), wherein the sealing membrane (defined by the combination of 2004 and 2000) in the nasal support regions (2009) has a greater thickness than in the cheek support regions (2006), and wherein the sealing membrane (defined by the combination of 2004 and 2000) in the compliant nasal region (2002) and the complaint base region (2008) has a thickness that is less than in the cheek support region (2006) and the nasal support regions (2009), and a sidewall portion (via 1114, best shown in Figure 4) extending between the mask connection interface (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6, whereby the as seen in Figure 4, the compliant inner membrane embraces the sidewall of the mask body 2102, as seen in Figure 7, and similarly shown in cross section as 1102 of Figure 4) and the patient interface portion, wherein the sidewall portion (via 1114, best shown Figure 4)comprises reinforced sidewall regions (defined by the shelfs at 1156 and the lateral extension proximate the gas inlet, as best seen in Figure 4 to support the sealing cushion) disposed between the cheek support regions (2006) and the mask connection interface (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6, whereby the as seen in Figure 4, the compliant inner membrane embraces the sidewall of the mask body 2102, as seen in Figure 7, and similarly shown in cross section as 1102 of Figure 4) and/or between the nasal support regions (2009) and the cheek support
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As to Claim 35, McAuley discloses the sidewall portion (via 1114, best shown in Figure 4) comprises a nasal bridge support region (via 2002, defined by the shelfs at 1156 and the lateral extension proximate the gas inlet, as best seen in Figure 4 to support the sealing cushion) disposed at an apex of the sidewall portion (via 1114, best shown in Figure 4), and wherein the reinforced sidewall regions (defined by the shelfs at 1156 and the lateral extension proximate the gas inlet, as best seen in Figure 4 to support the sealing cushion) and the nasal bridge support regions (via 2002, defined by the shelfs at 1156 and the lateral extension proximate the gas inlet, as best seen in Figure 4 to support the sealing cushion) have the same thickness.
As to Claim 36, McAuley discloses the sidewall portion (via 1114, best shown in Figure 4) comprises a nasal bridge support region (via 2002, defined by the shelfs at 1156 and the lateral extension proximate the gas inlet, as best seen in Figure 4 to support the sealing cushion) disposed at an apex of the sidewall portion (via 1114, best shown in Figure 4), and wherein the nasal bridge support region (via 2002, defined by the shelfs at 1156 and the lateral extension proximate the gas inlet, as best seen in Figure 4 to support the sealing cushion) extends between the mask connection interface (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6, whereby the as seen in Figure 4, the compliant inner membrane embraces the sidewall of the mask body 2102, as seen in Figure 7, and similarly shown in cross section as 1102 of Figure 4) and the compliant nasal region (2002) and/or between the nasal support regions (2009).
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 1, 4, 6, 7, 11, 13, 15-17, 26, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over McAuley et al. (2010/0006101) in view of Worboys et al. (2008/00006277).
As to Claims 1 and 26, McAuley discloses a sealing cushion (best seen Figures 8 and 9) for a respiratory mask assembly (as shown in Figure 7), the sealing cushion (best seen Figures 8 and 9) comprising a patient interface portion (best seen Figure 8) having a resilient deformable sealing membrane (defined by the combination of 2004 and 2000, “The outer sheath 2004 contacts the inner cushion 2000 throughout the raised bridge 2002.” Para 0101) for engagement with a patient’s face, and an aperture (defined by the central opening in the combination of 2004 and 2000) formed therein for receiving a nasal and/or mouth region of a patient’s face, the sealing membrane (defined by the combination of 2004 and 2000) comprising a plurality of regions of different thicknesses (best seen Figure 9), wherein the thickness of the region is defined as the depth of the sealing membrane (defined by the combination of 2004 and 2000) in that region, the plurality of regions comprising: a compliant nasal region (2002, “In the second embodiment the inner cushion 2000 includes a raised bridge 2002 in the nasal bridge region.” Para 0101) for engagement with the patient’s nasal bridge, nasal support regions (2009, “The peaks 2005, 2007, 2009, 2011 in the inner cushion 2000 between each of the indented sections 2006, 2008 and the raised bridge 2002 contact the outer sheath 2004 and when in use the sheath 2004 contacts the facial contours of the patient in the regions of these peaks.” Para 0101) disposed either side of the compliant nasal region (2002) for engagement with the sides of the patient’s nose, cheek support regions (2006, “The peaks 2005, 2007, 2009, 2011 in the inner cushion 2000 between each of the indented sections 2006, 2008 and the raised bridge 2002 contact the outer sheath 2004 and when in use the sheath 2004 contacts the facial contours of the patient in the regions of these peaks.” Para 0101; also see: “Referring particularly to FIG. 10 the inner cushion 2000 includes a cheek contour 2006 to follow the cartilage extending from the middle of the nose, and a contoured lip scaling portion 2008 to seal between the base of the nose and the upper lip.” Para 0102) extending from each nasal support region (2009) for engagement with at least the patient’s cheeks, and a compliant base region (2008, “The peaks 2005, 2007, 2009, 2011 in the inner cushion 2000 between each of the indented sections 2006, 2008 and the raised bridge 2002 contact the outer sheath 2004 and when in use the sheath 2004 contacts the facial contours of the patient in the regions of these peaks.” Para 0101) extending between the cheek support regions (2006), wherein the sealing membrane (defined by the combination of 2004 and 2000) in the nasal support regions (2009) has a greater thickness than in the cheek support regions (2006), and wherein the sealing membrane (defined by the combination of 2004 and 2000) in the compliant nasal region (2002) and the complaint base region (2008) has a thickness that is less than in the cheek support region (2006) and the nasal support regions (2009).
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Yet, McAuley does not expressly disclose the construction “wherein each cheek support region comprises a reinforced subregion that is separated from the nasal support regions.”
Worboys teaches an additional respiratory mask assembly (10, “FIG. 7 illustrates a patient interface in the form of a full-face mask 10 including a cushion 14 in accordance with an embodiment of the invention.” Para 0025), similar to McAuley, having a sealing cushion (best seen Figure 7) wherein the sealing cushion (best seen Figure 7) comprises a patient interface portion (14, best seen Figure 7 “As illustrated, the cushion 14 has a thin outer membrane 16 and a thicker underlying membrane 18 generally spaced away from the outer membrane 16. The outer membrane 16 provides a sealing structure to form a seal with the patient's face, and the underlying membrane 18 (also referred to as an underlying support) provides a support structure for the outer membrane 16.” Para 0026) having a resiliently deformable sealing membrane (16, “a thin outer membrane 16”) for engagement with a patient’s face, and an aperture (defined by the inner perimeter of 16) formed therein for receiving a nasal and/or mouth region of the patient’s face (“The outer membrane 16 provides a sealing structure to form a seal with the patient's face”), the sealing membrane (16) comprising a plurality of regions including a complaint nasal region (NB, “In the illustrated embodiment, the outer membrane 16 forms a seal with a nasal bridge region NB, cheek regions CR, and a lower lip region LL of the patient's face.” Para 0027) for engagement with the patient’s nasal bridge, nasal support regions (CR proximate NB above the air inlet hole, “cheek regions CR” Para 0027) disposed either side of the compliant nasal region (NB) for engagement with the sides of the patient’s nose, cheek support region (CR proximate LL below the air inlet hole, “cheek regions CR” Para 0027) extending from each of the nasal support regions (CR proximate NB above the air inlet hole) for engagement with at least the patient’s cheeks, and a compliant base region (LL, “a lower lip region LL of the patient's face.” Para 0027) extending between the cheek support regions (CR proximate LL below the air inlet hole).
Regarding the remaining limitations of the claims, Worboys teaches the construction of a reinforced subregion (18, “the underlying membrane 18 (also referred to as an underlying support) provides a support structure for the outer membrane 16.” Para 0026) within the cheek support region (on 16 - CR proximate LL below the air inlet hole) that is separated from the nasal support regions (on 16 - CR proximate NB above the air inlet hole) for the purpose of providing additional support compared to the regions whereby the reinforced subregion (18) is absent – thus having more flexibility when contacted with the face (Para 0031).
Further, Worboys teaches the number of walls within the patient interface portion may be readily adjusted to accommodate the various comforts of patients as well as provide regions of comfort along sensitive areas of the patient’s face/skin (Para 0027: “The single wall construction at the top and bottom of the cushion 14 allows flexibility to accommodate a wide range of patients. However, the cushion 14 may have any other suitable construction, e.g., single walled, triple walled or more walled construction, in any suitable region of the cushion 14.”; Para 0031: “Reducing or eliminating the underlying membrane 18 in these regions of the cushion 14 means the outer membrane 16 can "give" more when a face contacts it. This arrangement can improve comfort in these sensitive regions.”).
In light of the teachings of Worboys, the modification of McAuley to include an additional region within the cheeks support region – in the form of a reinforced subregion - would be obvious in order to meet the desired comfort along the areas of the patient’s face/skin.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface portion of McAuley to additionally include a reinforced subregion, within the cheek support region, as taught by Worboys to provide varying degrees of support and flexibility along the shape of the sealing cushion as abutting the patient’s face/skin.
As to Claim 4, the modified McAuley, specifically Worboys teaches the construction of a patient interface portion and/or aperture therein having a substantially triangular shape in nature to afford the encompassing of the nose of the patient (as best seen in Figure 7).
As to Claim 6, the modified McAuley, specifically McAuley discloses the thickness of each of the plurality of regions is constant across the region (best seen Figure 9) and the transitions between the plurality of regions are distinct step-like transitions.
As best seen in Figure 9, each of the claimed recited regions includes a distinct and constant thickness represented by greater thickness in the form of peaks or less thickness in the form of indents. Although clearly McAuley shows the construction at 2011 of an additional peak between the claimed “cheek support region” 2006 and the claimed “compliant base region” (2008), the open language of the claims does not preclude, prevent, or hinder the inclusion of additional non-recited regions whereby undulations between claimed regions may occur. Thus, the modified McAuley meets the limitations of the claims.
As to Claim 7, the modified McAuley, specifically Worboys teaches the construction of the reinforced subregion (18) disposed at base corners (best seen Figure 7) of the patient interface portion (14).
As to Claim 11, the modified McAuley, specifically McAuley discloses the nasal support regions (2009) extend along the left and right sides of the patient interface portion between the compliant nasal region (2002) and the cheek support regions (2006).
As to Claim 13, the modified McAuley, specifically McAuley discloses the cheek support regions (2069) extend along the left and right sides of the patient interface portion between the nasal support regions (2009) and a base corners of the patient interface portion, and wherein the cheek support regions (2006) further extend along a base side of the patient interface portion between the base corners and the compliant base region (2008).
As to Claim 15, the modified McAuley, specifically McAuley discloses the sealing cushion (best seen Figures 8 and 9) comprises a mask connection interface (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6) for connection to a respiratory mask body (2102, as seen in Figure 7, and similarly shown in cross section as 1102 of Figure 4) and a sidewall portion (via 1114, best shown in Figure 4) extending between the mask connection interface (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6) and the patient interface portion, and wherein the compliant base region (2008) extends across the sidewall portion (via 1114, best shown in Figure 4).
As to Claim 16, the modified McAuley, specifically Worboys teaches the reinforced subregion (18) comprises substantially square shaped portions (best seen Figures 10 and 11, wherein Figure 10 shows undulating rectangles and Figure 11 shows separate rectangle fingers).
As to Claim 17, the modified McAuley, specifically McAuley discloses the sealing cushion (best seen Figures 8 and 9) comprises a mask connection interface (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6) for connection to a respiratory mask body (2102, as seen in Figure 7, and similarly shown in cross section as 1102 of Figure 4) and a sidewall portion (via 1114, best shown in Figure 4) extending between the mask connection interface (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6) and the patient interface portion.
Regarding the remaining limitations, the modified McAuley, specifically Worboys teaches the reinforced subregion (18) extend from the patient interface portion (14) across the sidewall portion (best seen Figure 6B wherein 43 abuts 41 at 44) of the modified McAuley.
As to Claim 33, McAuley discloses the nasal support regions (2009) also extend across at least a portion of the sidewall portion (via 1114, best shown in Figure 4), whereby McAuley discloses the sidewall portion (via 1114, best shown in Figure 4) comprises reinforced sidewall regions (defined by the shelfs at 1156 and the lateral extension proximate the gas inlet, as best seen in Figure 4 to support the sealing cushion) and the cheek support regions (2006) extend between the complaint inner member (best seen in Figure 8 by the inverted U at the perimeter of 2004, and similarly shown in Figures 4-6) and the reinforced sidewall regions (defined by the shelfs at 1156 and the lateral extension proximate the gas inlet, as best seen in Figure 4 to support the sealing cushion).
Yet, McAuley does not expressly disclose the construction yields the formation of “a reinforced subregion of the sidewall portion.”
Worboys teaches an additional respiratory mask assembly (10, “FIG. 7 illustrates a patient interface in the form of a full-face mask 10 including a cushion 14 in accordance with an embodiment of the invention.” Para 0025), similar to McAuley, having a sealing cushion (best seen Figure 7) wherein the sealing cushion (best seen Figure 7) comprises a patient interface portion (14, best seen Figure 7 “As illustrated, the cushion 14 has a thin outer membrane 16 and a thicker underlying membrane 18 generally spaced away from the outer membrane 16. The outer membrane 16 provides a sealing structure to form a seal with the patient's face, and the underlying membrane 18 (also referred to as an underlying support) provides a support structure for the outer membrane 16.” Para 0026) having a resiliently deformable sealing membrane (16, “a thin outer membrane 16”) for engagement with a patient’s face, and an aperture (defined by the inner perimeter of 16) formed therein for receiving a nasal and/or mouth region of the patient’s face (“The outer membrane 16 provides a sealing structure to form a seal with the patient's face”), the sealing membrane (16) comprising a plurality of regions including a complaint nasal region (NB, “In the illustrated embodiment, the outer membrane 16 forms a seal with a nasal bridge region NB, cheek regions CR, and a lower lip region LL of the patient's face.” Para 0027) for engagement with the patient’s nasal bridge, nasal support regions (CR proximate NB above the air inlet hole, “cheek regions CR” Para 0027) disposed either side of the compliant nasal region (NB) for engagement with the sides of the patient’s nose, cheek support region (CR proximate LL below the air inlet hole, “cheek regions CR” Para 0027) extending from each of the nasal support regions (CR proximate NB above the air inlet hole) for engagement with at least the patient’s cheeks, and a compliant base region (LL, “a lower lip region LL of the patient's face.” Para 0027) extending between the cheek support regions (CR proximate LL below the air inlet hole).
Regarding the remaining limitations of the claims, Worboys teaches the construction of a reinforced subregion (18, “the underlying membrane 18 (also referred to as an underlying support) provides a support structure for the outer membrane 16.” Para 0026) within the cheek support region (on 16 - CR proximate LL below the air inlet hole) that is separated from the nasal support regions (on 16 - CR proximate NB above the air inlet hole) for the purpose of providing additional support compared to the regions whereby the reinforced subregion (18) is absent – thus having more flexibility when contacted with the face (Para 0031).
Further, Worboys teaches the number of walls within the patient interface portion may be readily adjusted to accommodate the various comforts of patients as well as provide regions of comfort along sensitive areas of the patient’s face/skin (Para 0027: “The single wall construction at the top and bottom of the cushion 14 allows flexibility to accommodate a wide range of patients. However, the cushion 14 may have any other suitable construction, e.g., single walled, triple walled or more walled construction, in any suitable region of the cushion 14.”; Para 0031: “Reducing or eliminating the underlying membrane 18 in these regions of the cushion 14 means the outer membrane 16 can "give" more when a face contacts it. This arrangement can improve comfort in these sensitive regions.”).
In light of the teachings of Worboys, the modification of McAuley to include an additional region within the cheeks support region – in the form of a reinforced subregion - would be obvious in order to meet the desired comfort along the areas of the patient’s face/skin.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface portion of McAuley to additionally include a reinforced subregion, within the cheek support region, as taught by Worboys to provide varying degrees of support and flexibility along the shape of the sealing cushion as abutting the patient’s face/skin.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot.
Newly located prior art McAuley et al. (2010/0006101) alone or in combination, appears to disclose the features of the amended independent claims, Claims 1, 27, and 32, whereby McAuley discloses a sealing cushion (best seen Figures 8 and 9) for a respiratory mask assembly (as shown in Figure 7), the sealing cushion (best seen Figures 8 and 9) comprising a patient interface portion (best seen Figure 8) having a resilient deformable sealing membrane (defined by the combination of 2004 and 2000, “The outer sheath 2004 contacts the inner cushion 2000 throughout the raised bridge 2002.” Para 0101) for engagement with a patient’s face, and an aperture (defined by the central opening in the combination of 2004 and 2000) formed therein for receiving a nasal and/or mouth region of a patient’s face, the sealing membrane (defined by the combination of 2004 and 2000) comprising a plurality of regions of different thicknesses (best seen Figure 9), wherein the thickness of the region is defined as the depth of the sealing membrane (defined by the combination of 2004 and 2000) in that region, the plurality of regions comprising: a compliant nasal region (2002, “In the second embodiment the inner cushion 2000 includes a raised bridge 2002 in the nasal bridge region.” Para 0101) for engagement with the patient’s nasal bridge, nasal support regions (2009, “The peaks 2005, 2007, 2009, 2011 in the inner cushion 2000 between each of the indented sections 2006, 2008 and the raised bridge 2002 contact the outer sheath 2004 and when in use the sheath 2004 contacts the facial contours of the patient in the regions of these peaks.” Para 0101) disposed either side of the compliant nasal region (2002) for engagement with the sides of the patient’s nose, cheek support regions (2006, “The peaks 2005, 2007, 2009, 2011 in the inner cushion 2000 between each of the indented sections 2006, 2008 and the raised bridge 2002 contact the outer sheath 2004 and when in use the sheath 2004 contacts the facial contours of the patient in the regions of these peaks.” Para 0101; also see: “Referring particularly to FIG. 10 the inner cushion 2000 includes a cheek contour 2006 to follow the cartilage extending from the middle of the nose, and a contoured lip scaling portion 2008 to seal between the base of the nose and the upper lip.” Para 0102) extending from each nasal support region (2009) for engagement with at least the patient’s cheeks, and a compliant base region (2008, “The peaks 2005, 2007, 2009, 2011 in the inner cushion 2000 between each of the indented sections 2006, 2008 and the raised bridge 2002 contact the outer sheath 2004 and when in use the sheath 2004 contacts the facial contours of the patient in the regions of these peaks.” Para 0101) extending between the cheek support regions (2006), wherein the sealing membrane (defined by the combination of 2004 and 2000) in the nasal support regions (2009) has a greater thickness than in the cheek support regions (2006), and wherein the sealing membrane (defined by the combination of 2004 and 2000) in the compliant nasal region (2002) and the complaint base region (2008) has a thickness that is less than in the cheek support region (2006) and the nasal support regions (2009).
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In light of the disclosure of McAuley, alone or in combination, it appears the features of the claims are met.
Thus, the rejection of the claims is maintained and made FINAL.
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 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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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785