DETAILED ACTION
This Office Action is in response to the filing of a preliminary amendment to the claims on 12/20/2023. As per the preliminary amendment, claims 1, 3-7, 10-12, and 14 have been amended, claims 2 and 15-43 have been cancelled, and no claims have been added. Thus, claims 1 and 3-14 are pending in the application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1 and 3-14 are objected to because of the following informalities:
Claim 1 recites the language “cheek portions extending laterally across the wearer’s cheek between the upper edges of the malar bones and the lower edge of the mandible of the wearer.” in lines 6-7. Examiner suggests changing to read --cheek portions configured to extend laterally across the wearer’s cheek between the upper edges of the malar bones and the lower edge of the mandible of the wearer.-- in order to ensure that the claim is not claiming a human body part.
Claims 3-14 each recite “A face mask” in line 1. Examiner suggests changing to read --The face mask-- in order to properly refer back to the face mask upon which the claim depends.
Claims 3-14 each refer to the claim they depend upon by reciting “Claim” with a capital “C.” Examiner suggests changing to read --claim-- with a lowercase “c” in order to remove unnecessary capitalization.
Claim 3 recites “the face mask extends laterally across the wearer’s cheeks” in lines 1-2. Examiner suggests changing to read --the face mask is configured to extend laterally across the wearer’s cheeks-- in order to ensure that the claim is not claiming a human body part.
Claim 3 recites the term “5cm” in line 2. Examiner suggests changing to read --5 centimeters (cm)-- in order to properly label to abbreviation. Further, line 2 recites “3cm” and “2cm” which should be changing to read --3 cm-- and --2 cm-- respectively in order to have a space between the numeral and abbreviation.
Claim 5 recites “the mask substantially covers the wearer’s cheeks” in line 2. Examiner suggests changing to read --the mask is configured to substantially cover the wearer’s cheeks.-- in order to ensure that the claim is not claiming a human body part.
Claim 7 recites “left- or right- side edge” in line 2 and line 4. Examiner suggests changing to read --left-side or right-side edge-- in order to not leave a hanging hyphen on the term “left.”
Claim 14 recites the language “the support frame and the filter extend laterally across the wearer’s cheeks” in liens 1-2. Examiner suggests changing to read -- the support frame and the filter are configured to extend laterally across the wearer’s cheeks-- in order to ensure that the claim is not claiming a human body part.
Appropriate correction 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.
Claim 4 is 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.
Claim 4 recites the language “may be” in line 3. It is unclear whether or not the limitations that follow are being positively recited, or whether they are optional/ exemplary. For the purposes of examination, claim 4 only requires that there is a distance between the side edges of the mask.
Claim 4 recites the limitation "the nasal region" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the chin region" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Any remaining claims are rejected for being dependent on a rejected claim.
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, 3-12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sabolis et al. (US Pub. 2016/0001101).
Regarding claim 1, Sabolis discloses a face mask (see the mask system of Fig. 1) comprising a mask body (face seal member 106, alongside frame 102 and filter 104 in Figs. 1-6) that defines a cavity for accommodating the nose and mouth of a wearer (see Figs. 1-6 and [0050] where the face seal member 106 covers over the mouth and nose) and from which a wearer inhales respiratory gases, in use (see [0068] where the cavity of the face seal member 106 allows for the flow of gases to the user to be inhaled), and a sealing member depending from the mask body for engagement with the wearer's face (see seal contact area 114 in Fig. 6), the mask body and the sealing member comprising a nasal portion for accommodating the nose of the wearer (see narrow nasal area 136 in Figs. 1-6), a mouth portion for accommodating the mouth of the wearer (see Fig. 6 the portion of face seal member 106 and seal contact area 114 that is below the nasal area 136 and covers around the mouth to define the rest of cavity 128), and cheek portions extending laterally across the wearer's cheeks between the upper edges of the malar bones and the lower edge of the mandible of the wearer (see Figs. 1-6 where frame 102 and filter 104 form laterally extending side portions that extent over the cheeks, between the malar bones and mandible of the wearer).
Regarding claim 3, Sabolis discloses wherein the face mask extends laterally across the wearer's cheeks such that an edge of the mask is situated, in use, within 5cm, or within 4 cm, or within 3cm, or within 2cm of the wearer's ears (it is noted that this limitation is dependent on the head shape and size of the individual using the mask, and Figs. 1-2 show an extension of the frame 102 that is able to be within at least 5cm of the ear of certain patients, such as neonates).
Regarding claim 4, Sabolis discloses wherein the distance between a first side edge of the mask body and an opposing side edge of the mask body, measured along the surface of the mask body (see Figs. 1-6 where the frame 102 has two lateral side edges, one left and one right, which are oppositely opposed from one another and at some distance. See above 35 U.S.C. 112(b) rejection for interpretation of this claim).
Regarding claim 5, Sabolis discloses wherein the mask substantially covers the wearer's cheeks (see Figs. 1-6 where the lateral extensions of frame 102 and filter 104 covers across at least a substantial portion of the cheeks).
Regarding claim 6, Sabolis discloses wherein the portions of the mask body which extend across the wearer's cheeks form a shallower cavity between the mask body and the wearer's face than the portion of the mask body which extends over the wearer's nose and mouth (see Figs. 1-6 where the frame 102 and filter 104 have a slight curve to them, forming a shallow cavity between them and the face of the user; and where the cavity formed by face seal member 106 fits around the mouth and nose with a deeper cavity and more pronounced curvature such that the cavity is less shallow).
Regarding claim 7, Sabolis discloses wherein the cheek portions each have a first edge that extends from a left- or right- side edge of the nasal portion (see annotated Fig. 1 below, a first edge extending from sides of a nasal portion), and is accommodated over the malar bone of the wearer, and a second edge that extends from a left- or right-side edge of the mouth portion (see annotated Fig. 1 below, where the extension of the first edge passes over at least some part of the malar bone, depending on the size and shape of the user’s head), such that the second edge of the cheek portion is accommodated above the lower edge of the mandible of the wearer (see annotated Fig. 1 below, the second edge above a lower edge of the mandible), wherein the angle between tangent lines to the first and second edges of each cheek portion decreases with increasing lateral position (see annotated Fig. 1 below where the first edge tapers from the center (about the nose) to a flatter shape as it extends laterally outward, such that its tangent decreases as it extends towards the first and second side edges).
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Regarding claim 8, Sabolis discloses wherein the cheek portions each further comprise a side edge which extends between a distal end of the first edge and a distal end of the second edge (see above annotated Fig. 1, the side edges).
Regarding claim 9, Sabolis discloses where the side edge comprises a substantially linear edge (see above annotated Fig. 1, the side edges being at least substantially linear).
Regarding claim 10, Sabolis discloses wherein the angle between the side edge and the first edge is between 70 and 110 degrees (see above annotated Fig. 1, where the angle from the first edge to side edge is approximately 90 degrees, such that it is clearly within the 70-110 degree range).
Regarding claim 11, Sabolis discloses wherein the first edge is concave in shape (see above annotated Fig. 1, where the curvature of the first edge is concave about the nose) .
Regarding claim 12, Sabolis discloses wherein the face mask is a filter mask (see abstract, and filter 104 in Figs. 1-6), and the mask body is defined by the support frame and the filter (see Figs. 1-6 where the body of the mask includes and is thus defined at least in part by frame 102 and filter 104).
Regarding claim 14, Sabolis discloses wherein the support frame and the filter extend laterally across the wearer's cheeks in the cheek portions of the mask body (see figs. 1-6 where frame 102 and filter 104 extend in the lateral direction across cheeks of the wearer, the cheek portions made of the frame and filter such that they are in the cheek portions).
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sabolis as applied to claim 12 above, and further in view of Davidson et al. (US Pat. 8,869,797).
Regarding claim 13, Sabolis discloses the sealing member and the support frame.
Sabolis lacks a detailed description of wherein the sealing member extends about the periphery of the support frame.
However, Davidson teaches a worn respiratory mask with a frame and sealing member, where a support frame member (see Fig. 7-1 cushion clip 70) has the sealing member extending about its periphery (see Fig. 7-1 where cushion 95 extends about the peripheral edges of cushion clip 70 when joined together).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mask body of Sabolis to have the frame support member clip connected to a peripherally located sealing cushion as taught by Davidson, as it would provide a rigid support for the sealing cushion member, while also allowing for easy removal and replacement of the sealing cushion from the mask to allow for easier reuse of the mask (Davidson; see Col. 6 line 46 to Col. 7 line 23).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Harold et al. (US Pat. 7,766,015), Noh et al. (US Pat. 9,408,424), Bergman (US Pat. 10,449,398), Henderson (US Pat. 11,213,080), and Tsuei (US Pat. 9,616,258) are cited to show similar respiratory mask devices having filters and/or frames and/or cheek extending portions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785