DETAILED ACTION
Primary Examiner acknowledges Claims 1-20 are pending in this application as originally filed on May 8, 2023.
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 18 are objected to because of the following informalities:
Claim 1, Line 3 and Claim 18, Line 3 both recite “two cheek coving regions”. It appears this limitation should be “covering”. Appropriate correction and clarification is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “means for actively reducing dead space of the facemask cup” as referenced in Claim 18 and its dependents of Claims 19 and 20.
Despite Applicant’s recitation of “means for” there does not appear to be a clear and unmistakable disclosure as to the breadth and scope of what particular corresponding structure that performs the functionality of “actively reducing dead space of the facemask cup”.
In a review of the original specification as filed:
Para 0010 states “a reduction in dead space of a facemask when worn by a patient to improve oxygen efficiency used by the patient.”
Para 0010 also states “placement of a retaining strap across the facemask or optionally anchored just below the nose portion on either side of the nose portion of the facemask to reduce dead space and provide flexibility to reduce the potential for obstructing a person's nostrils base on a variety of different face shapes and sizes.”
Para 0019 states “One benefit of the head strap 255 looping between the inlet tube 120 and the mouth-region 104 (i.e., crossing the midline 311) is that the strap portion 310 can pull the pliable facemask 100 towards the person's face 200 thereby reducing dead space 450 in the facemask 100 (see FIG. 6B).”
Para 0019 also states “Dead space 450 is defined as any space between the interior region 702 of the facemask 400 and a person's face 200. Reduced dead space 450 allows the facemask 100 to be more efficient, requiring less pure oxygen to operate while supplying the oxygen at a higher concentration to the patient 101 than what any prior art facemask is capable of because there will be less CO2 exhalant diluting the incoming O2.”
Para 0021 states “The head strap 150 is shown pulling the pliable facemask 100 against the person's face 200 under their nose 140 and above their mouth 142 (philtrum), across the midline of the facemask 400, to reduce dead space 450 in the front of their face 200.”
Para 0021 also states “The head strap configuration 150 (either with the strap portion 310 or without the strap portion 310 so long as the head strap anchors 118 are within 1.25 inches from the midline 311, and preferably less than 1 inch from the midline 311) actively reduces dead space of the facemask cup 151 by pulling the facemask 400 into the person's face between their nose 140 and upper lip.”
Para 0022 states “an upper lip region between the inlet tube 120 and the mouth region perforations 105 being thinner than the average high stiffness region 504 to facilitate easier deflection of the facemask 500 towards a human face 200 to reduce dead space 450.”
Para 0053 states “The reduced dead space adult facemask 100 embodiment further comprising at least one strap anchor 118 between the inlet tube 120 and the mouth covering region 104 configured to retain a head retention strap 150, the strap anchor 118 is less than 1.25 inches from a facemask midline 311 defined as extending along the center of the facemask 100 bisecting the nose covering region 102 and the mouth covering region 104.”
Para 0054 states “The reduced dead space adult facemask 100 embodiment further contemplating wherein no part of an interior portion 702 of the facemask cup 151 is more than 0.35 inch from a human face 200, the interior portion 702 is defined as the interior surface of the facemask cup 151 that is configured to face the person's face 200.”
Para 0055 states “The reduced dead space adult facemask 100 embodiment further considering wherein at least 90% of an interior portion 702 of the facemask cup 151 is within one eighth of an inch from a human face 200, the interior portion 702 is defined as the interior surface of the facemask cup 151 that is configured to face the person's face 200.”
Para 0056 states “The reduced dead space adult facemask 100 embodiment further comprising a head strap 150 that crosses over a facemask midline 311 between the inlet tube 120 and the mouth covering region 104, the facemask midline 311 is defined as extending along the center of the facemask 100 bisecting the nose covering region 102 and the mouth covering region 104.”
Para 0057 states “The reduced dead space adult facemask 100 embodiment further envisioning wherein the facemask 100 is a unitary polymer element.”
Para 0058 states “The reduced dead space adult facemask 100 embodiment further cimagining wherein each of the cheek rims 114 extend away from the mouth covering region 104 in an elongated flared lateral touch region 111 at least one inch in length 117 to a cheek rim apex 192 at a right angle 197 from a vertical reference line 189 defined by a 90°reference angle 195 that passes through the face mask nose bridge rim apex 188 along the Y-axis 189 and the chin rim apex 186 along the X-axis 191.”
In light of the aforementioned citations of the original disclosure as filed, Primary Examiner is unsure what specific structure provides for the functionality of the “means for actively reducing dead space of the facemask cup” as referenced in Claim 18 and its dependents of Claims 19 and 20. Primary Examiner is unsure if the “actively reducing dead space of the facemask cup” is a reference to a generic head strap utilized to secure the facemask to the face of the patient, the specific structure of the head strap having an anchor point anterior to the facemask for securing the facemask to the face of the patient, the material composition of the facemask having “thinner than the average high stiffness region 504 to facilitate easier deflection of the facemask 500” and/or “a unitary polymer element”, the conformity of the facemask to meet the facial features of the face (e.g. 3D modeled to the face of the patient) to achieve “wherein no part of an interior portion 702 of the facemask cup 151 is more than 0.35 inch from a human face 200” and/or “at least 90% of an interior portion 702 of the facemask cup 151 is within one eighth of an inch from a human face 200” and/or “each of the cheek rims 114 extend away from the mouth covering region 104 in an elongated flared lateral touch region 111 at least one inch in length 117 to a cheek rim apex 192 at a right angle 197 from a vertical reference line 189 defined by a 90°reference angle 195 that passes through the face mask nose bridge rim apex 188 along the Y-axis 189 and the chin rim apex 186 along the X-axis 191”, or any combination above. Thus, the claim limitation of the “means for actively reducing dead space of the facemask cup” as referenced in Claim 18 and its dependents of Claims 19 and 20, is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph as there is no clear and unmistakable disclosure as to the breadth and scope of what particular corresponding structure that performs the functionality of “actively reducing dead space of the facemask cup”.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
For purposes of this rejection, Primary Examiner will address the concept of the “means for actively reducing dead space of the facemask cup” as referenced in Claim 18 with respect to the general consensus of a generic head strap associated with the facemask that is operated in tension/pulling action to secure the facemask to the face of the patient, thereby reducing the dead space between the facemask and the patient’s face.
Dependent claims, Claims 19 and 20 incorporate the subject matter from which they depend. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 112 (b) or 2nd Paragraph
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 1-9 and 18-20 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, both Claim 1, Line 5 and Claim 18, Line 5 recite the limitation “nose covered region”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure if this limitation of “nose covered region” is meant to be coextensive with the former recitation of “nose covering region” as initially referenced in Claim 1, Line 2 and Claim 18, Line 2 respectively, or if this is meant to reference a separate and distinct feature. Primary Examiner notes dependent claims, Claims 2 and 5, from Claim 1 expressly recite the former recitation of “nose covering region” as initially referenced in Claim 1, Line 2. Thus perhaps the recitation of “nose covered region” is simply a typo. Nevertheless, dependent claims, Claims 2-9, 19, and 20 incorporate the indefinite subject matter from which they depend. For purposes of this rejection, Primary Examiner will presume the terms are meant to be coextensive. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 112 (f) or 6th Paragraph
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Claim limitation “means for actively reducing dead space of the facemask cup” appears to attempt to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Despite Applicant’s recitation of “means for” there does not appear to be a clear and unmistakable disclosure as to the breadth and scope of what particular corresponding structure that performs the functionality of “actively reducing dead space of the facemask cup”.
In a review of the original specification as filed:
Para 0010 states “a reduction in dead space of a facemask when worn by a patient to improve oxygen efficiency used by the patient.”
Para 0010 also states “placement of a retaining strap across the facemask or optionally anchored just below the nose portion on either side of the nose portion of the facemask to reduce dead space and provide flexibility to reduce the potential for obstructing a person's nostrils base on a variety of different face shapes and sizes.”
Para 0019 states “One benefit of the head strap 255 looping between the inlet tube 120 and the mouth-region 104 (i.e., crossing the midline 311) is that the strap portion 310 can pull the pliable facemask 100 towards the person's face 200 thereby reducing dead space 450 in the facemask 100 (see FIG. 6B).”
Para 0019 also states “Dead space 450 is defined as any space between the interior region 702 of the facemask 400 and a person's face 200. Reduced dead space 450 allows the facemask 100 to be more efficient, requiring less pure oxygen to operate while supplying the oxygen at a higher concentration to the patient 101 than what any prior art facemask is capable of because there will be less CO2 exhalant diluting the incoming O2.”
Para 0021 states “The head strap 150 is shown pulling the pliable facemask 100 against the person's face 200 under their nose 140 and above their mouth 142 (philtrum), across the midline of the facemask 400, to reduce dead space 450 in the front of their face 200.”
Para 0021 also states “The head strap configuration 150 (either with the strap portion 310 or without the strap portion 310 so long as the head strap anchors 118 are within 1.25 inches from the midline 311, and preferably less than 1 inch from the midline 311) actively reduces dead space of the facemask cup 151 by pulling the facemask 400 into the person's face between their nose 140 and upper lip.”
Para 0022 states “an upper lip region between the inlet tube 120 and the mouth region perforations 105 being thinner than the average high stiffness region 504 to facilitate easier deflection of the facemask 500 towards a human face 200 to reduce dead space 450.”
Para 0053 states “The reduced dead space adult facemask 100 embodiment further comprising at least one strap anchor 118 between the inlet tube 120 and the mouth covering region 104 configured to retain a head retention strap 150, the strap anchor 118 is less than 1.25 inches from a facemask midline 311 defined as extending along the center of the facemask 100 bisecting the nose covering region 102 and the mouth covering region 104.”
Para 0054 states “The reduced dead space adult facemask 100 embodiment further contemplating wherein no part of an interior portion 702 of the facemask cup 151 is more than 0.35 inch from a human face 200, the interior portion 702 is defined as the interior surface of the facemask cup 151 that is configured to face the person's face 200.”
Para 0055 states “The reduced dead space adult facemask 100 embodiment further considering wherein at least 90% of an interior portion 702 of the facemask cup 151 is within one eighth of an inch from a human face 200, the interior portion 702 is defined as the interior surface of the facemask cup 151 that is configured to face the person's face 200.”
Para 0056 states “The reduced dead space adult facemask 100 embodiment further comprising a head strap 150 that crosses over a facemask midline 311 between the inlet tube 120 and the mouth covering region 104, the facemask midline 311 is defined as extending along the center of the facemask 100 bisecting the nose covering region 102 and the mouth covering region 104.”
Para 0057 states “The reduced dead space adult facemask 100 embodiment further envisioning wherein the facemask 100 is a unitary polymer element.”
Para 0058 states “The reduced dead space adult facemask 100 embodiment further cimagining wherein each of the cheek rims 114 extend away from the mouth covering region 104 in an elongated flared lateral touch region 111 at least one inch in length 117 to a cheek rim apex 192 at a right angle 197 from a vertical reference line 189 defined by a 90°reference angle 195 that passes through the face mask nose bridge rim apex 188 along the Y-axis 189 and the chin rim apex 186 along the X-axis 191.”
In light of the aforementioned citations of the original disclosure as filed, Primary Examiner is unsure what specific structure provides for the functionality of the “means for actively reducing dead space of the facemask cup” as referenced in Claim 18 and its dependents of Claims 19 and 20. Primary Examiner is unsure if the “actively reducing dead space of the facemask cup” is a reference to a generic head strap utilized to secure the facemask to the face of the patient, the specific structure of the head strap having an anchor point anterior to the facemask for securing the facemask to the face of the patient, the material composition of the facemask having “thinner than the average high stiffness region 504 to facilitate easier deflection of the facemask 500” and/or “a unitary polymer element”, the conformity of the facemask to meet the facial features of the face (e.g. 3D modeled to the face of the patient) to achieve “wherein no part of an interior portion 702 of the facemask cup 151 is more than 0.35 inch from a human face 200” and/or “at least 90% of an interior portion 702 of the facemask cup 151 is within one eighth of an inch from a human face 200” and/or “each of the cheek rims 114 extend away from the mouth covering region 104 in an elongated flared lateral touch region 111 at least one inch in length 117 to a cheek rim apex 192 at a right angle 197 from a vertical reference line 189 defined by a 90°reference angle 195 that passes through the face mask nose bridge rim apex 188 along the Y-axis 189 and the chin rim apex 186 along the X-axis 191”, or any combination above. Thus, the claim limitation of the “means for actively reducing dead space of the facemask cup” as referenced in Claim 18 and its dependents of Claims 19 and 20, is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as there is no clear and unmistakable disclosure as to the breadth and scope of what particular corresponding structure that performs the functionality of “actively reducing dead space of the facemask cup”.
For purposes of this rejection, Primary Examiner will address the concept of the “means for actively reducing dead space of the facemask cup” as referenced in Claim 18 with respect to the general consensus of a generic head strap associated with the facemask that is operated in tension/pulling action to secure the facemask to the face of the patient, thereby reducing the dead space between the facemask and the patient’s face.
Dependent claims, Claims 19 and 20 incorporate the subject matter from which they depend. Appropriate correction and clarification is required.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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, 8, and 18 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Rudolph (5,265,595).
As to Claim 1, Rudolph discloses a reduced dead space adult facemask (Figures 1-3, “This invention relates to an oral respiratory mask to provide breath-by-breath measurements of respiration and metabolism in adults or children.” Column 1, Lines 15-25; “the present invention provides a mask which, because of its curvature and flexibility, may be used to provide highly accurate breath-by-breath measurements of respiration and metabolism in adults and children.” Column 2, Lines 20-30; “The present invention consists primarily of a respiratory mask having a relatively very small minimum dead air space, a unique directional airflow regulating system and a face-sealing surface constructed for superior facial fit on both adults and children.” Column 2, Lines 30-40; “to provide such a face mask which is effective for use on adults or children” Column 3, Lines 30-55), comprising: a pliable adult sized facemask cup (5, “The respiratory apparatus 1 generally comprises a face mask or face piece 5, an airflow tubing assembly 6 and a face mask securing mean which in the illustrated embodiment comprises a flexible skull cap 10, adjustable securement straps 11 and strap fasteners 12. The face mask 5 is constructed of silicone or other like material that is preferably flexible and yet resilient and that does not cause substantial skin irritation to the user. The face mask 5 is a cup-like structure having an outer surface 20 and an inner surface 21 and positionable on the face of a user so as to generally encircle and enclose the nose and mouth of the user. An endless outer peripheral edge 22 of the face mask 5 is shaped to conform with the shape of the face of an average user of the mask and generally conforms to the shape of the face upon which the mask 5 is secured. ” Column 4, Lines 40-65) that is essentially defined by a nose covering region (28, “A separating wall 27 extends across the inner surface of the face mask 5 so as to separate the volume enclosed by the mask 5 when secured to a wearer's face into a nose-enclosing chamber 28 and a mouth-enclosing chamber 29.” Column 4, Line 60 thru Column 5, Line 15), a mouth covering region (29, “A separating wall 27 extends across the inner surface of the face mask 5 so as to separate the volume enclosed by the mask 5 when secured to a wearer's face into a nose-enclosing chamber 28 and a mouth-enclosing chamber 29.” Column 4, Line 60 thru Column 5, Line 15), two cheek covering regions (34/34 laterally extending from the nose covering region 28, “The mask 5 includes sealing means, such as a sealing flange 34, which is integrally formed with and extends inwardly from the peripheral edge 22 of the mask 5, except at a lower portion 35 thereof, so as to extend partially over the area enclosed by the mask 5 in spaced relation with the inner surface 21 of the mask.” Column 4, Line 60 thru Column 5, Line 15), and a perimeter (22, “An endless outer peripheral edge 22 of the face mask 5 is shaped to conform with the shape of the face of an average user of the mask and generally conforms to the shape of the face upon which the mask 5 is secured.” Column 4, Lines 50-65), the perimeter (22) defined by a nose bridge rim (via 34 vertical to the nose covering region 28), two cheek rims (via 34/34 laterally extending from the nose covering region 28), and a chin rim (via 34 at 40, “At the lower portion 35 of the peripheral edge 22, the sealing flange 34 extends across the inner surface 21 of the face mask 5 so as to be spaced inwardly away from the peripheral edge 22 such that generally at the lower portion 35 of the peripheral edge 22 the inner surface 21 of the mask 5 and the sealing flange 34 form a chin receiving surface 40 adapted to conform to the shape of a user's chin positioned thereagainst.” Column 4, Line 60 thru Column 5, Line 15), the nose covering region (28) shaped to conform to an adult human nose (best seen Figure 3), the mouth covering region (29) configured to be in front of an adult human mouth (best seen Figure 3), the cheek covering regions (34/34 laterally extending from the nose covering region 28) configured to at least partially contact corresponding sides of adult human cheeks (best seen Figure 1); an inlet tube (114, “an inhalation intake tube 114 having an inhalation intake passageway 115 extending therethrough is threadingly secured to the Y-branched tube 95 so that the inhalation intake passageway 115 extends in axial alignment and in flow communication with the inhalation airflow passageway 98.” Column 6, Lines 20-40) outwardly extending from the adult facemask (Figures 1-3), the inlet tube (114) generally defined by a passageway (98, “inhalation airflow passageway 98.” Column 6, Lines 20-40) that leads through a distal aperture (115, “inhalation intake passageway 115” Column 6, Lines 20-40) and nose aperture (50, “A circular opening 50 extends through the face mask 5 so as to flow communicate with the mouth-enclosing chamber 29.” Column 5, Lines 30-60; also see: “The mask 5 is positioned so that the mouth opening of the user is flow aligned with the circular passageway 50 in the mask 5 and the common airflow passageway 96 in the airflow tubing assembly 6.” Column 8, Lines 5-20 and “When the mask 5 is secured in position, the mouth of the wearer is positioned in closely spaced relationship with the circular opening 50 of the mask 5 to reduce the dead space volume.” Column 8, Lines 40-55) in the facemask, a facemask cup volume that is essentially defined by a maximum amount of water the facemask cup can hold, the facemask cup volume less than 6.1 cubic inches (“Preferably the gas volume in the chamber 29 of the mask apparatus 1 is below approximately 125 milliliters and even more preferably below 36 milliliters.” Column 8, Lines 50-60).
Regarding the limitation “a facemask cup volume that is essentially defined by a maximum amount of water the facemask cup can hold”, although Applicant utilizes “water” as the medium by which the volume is measured, the disclosure of Rudolph effectively meets the limitations of the claims as the disclosed medium of “gas” encompasses the same shape. Hence, Applicant’s reliance on the “amount of water” does not affect the volume as the shapes and thus containment structure upon which the medium is remains the same.
Regarding the “less than 6.1 cubic inches”, the disclosed “more preferably below 36 milliliters” of Rudolph converts to approximately 2.197 cubic inches. Thus, Rudolph’s volume meets the limitations of being “less than 6.1 cubic inches”.
Thus, Rudolph appears to meet the limitations of the claims.
As to Claim 8, Rudolph discloses the facemask (Figures 1-3) is a unitary polymer element (“ The face mask 5 is constructed of silicone or other like material that is preferably flexible and yet resilient and that does not cause substantial skin irritation to the user.” Column 4, Lines 50-65).
As to Claim 18, Rudolph discloses a pliable adult facemask (Figures 1-3, “This invention relates to an oral respiratory mask to provide breath-by-breath measurements of respiration and metabolism in adults or children.” Column 1, Lines 15-25; “the present invention provides a mask which, because of its curvature and flexibility, may be used to provide highly accurate breath-by-breath measurements of respiration and metabolism in adults and children.” Column 2, Lines 20-30; “The present invention consists primarily of a respiratory mask having a relatively very small minimum dead air space, a unique directional airflow regulating system and a face-sealing surface constructed for superior facial fit on both adults and children.” Column 2, Lines 30-40; “to provide such a face mask which is effective for use on adults or children” Column 3, Lines 30-55; also see: “The face mask 5 is constructed of silicone or other like material that is preferably flexible and yet resilient and that does not cause substantial skin irritation to the user.” Column 4, Lines 50-65), comprising: a facemask cup (5, “The respiratory apparatus 1 generally comprises a face mask or face piece 5, an airflow tubing assembly 6 and a face mask securing mean which in the illustrated embodiment comprises a flexible skull cap 10, adjustable securement straps 11 and strap fasteners 12. The face mask 5 is constructed of silicone or other like material that is preferably flexible and yet resilient and that does not cause substantial skin irritation to the user. The face mask 5 is a cup-like structure having an outer surface 20 and an inner surface 21 and positionable on the face of a user so as to generally encircle and enclose the nose and mouth of the user. An endless outer peripheral edge 22 of the face mask 5 is shaped to conform with the shape of the face of an average user of the mask and generally conforms to the shape of the face upon which the mask 5 is secured. ” Column 4, Lines 40-65) that is essentially defined by a nose covering region (28, “A separating wall 27 extends across the inner surface of the face mask 5 so as to separate the volume enclosed by the mask 5 when secured to a wearer's face into a nose-enclosing chamber 28 and a mouth-enclosing chamber 29.” Column 4, Line 60 thru Column 5, Line 15), a mouth covering region (29, “A separating wall 27 extends across the inner surface of the face mask 5 so as to separate the volume enclosed by the mask 5 when secured to a wearer's face into a nose-enclosing chamber 28 and a mouth-enclosing chamber 29.” Column 4, Line 60 thru Column 5, Line 15), two cheek covering regions (34/34 laterally extending from the nose covering region 28, “The mask 5 includes sealing means, such as a sealing flange 34, which is integrally formed with and extends inwardly from the peripheral edge 22 of the mask 5, except at a lower portion 35 thereof, so as to extend partially over the area enclosed by the mask 5 in spaced relation with the inner surface 21 of the mask.” Column 4, Line 60 thru Column 5, Line 15), and a perimeter (22, “An endless outer peripheral edge 22 of the face mask 5 is shaped to conform with the shape of the face of an average user of the mask and generally conforms to the shape of the face upon which the mask 5 is secured.” Column 4, Lines 50-65), the perimeter (22) defined by a nose bridge rim (via 34 vertical to the nose covering region 28), two cheek rims (via 34/34 laterally extending from the nose covering region 28), and a chin rim (via 34 at 40, “At the lower portion 35 of the peripheral edge 22, the sealing flange 34 extends across the inner surface 21 of the face mask 5 so as to be spaced inwardly away from the peripheral edge 22 such that generally at the lower portion 35 of the peripheral edge 22 the inner surface 21 of the mask 5 and the sealing flange 34 form a chin receiving surface 40 adapted to conform to the shape of a user's chin positioned thereagainst.” Column 4, Line 60 thru Column 5, Line 15), the nose covering region (28) shaped to conform to an adult human nose (best seen Figure 3), the mouth covering region (29) configured to be in front of an adult human mouth (best seen Figure 3), the cheek covering regions (34/34 laterally extending from the nose covering region 28) configured to at least partially contact corresponding sides of adult human cheeks (best seen Figure 1); an inlet tube (114, “an inhalation intake tube 114 having an inhalation intake passageway 115 extending therethrough is threadingly secured to the Y-branched tube 95 so that the inhalation intake passageway 115 extends in axial alignment and in flow communication with the inhalation airflow passageway 98.” Column 6, Lines 20-40) outwardly extending from the adult facemask (Figures 1-3), the inlet tube (114) generally defined by a passageway (98, “inhalation airflow passageway 98.” Column 6, Lines 20-40) that leads through a distal aperture (115, “inhalation intake passageway 115” Column 6, Lines 20-40) and nose aperture (50, “A circular opening 50 extends through the face mask 5 so as to flow communicate with the mouth-enclosing chamber 29.” Column 5, Lines 30-60; also see: “The mask 5 is positioned so that the mouth opening of the user is flow aligned with the circular passageway 50 in the mask 5 and the common airflow passageway 96 in the airflow tubing assembly 6.” Column 8, Lines 5-20 and “When the mask 5 is secured in position, the mouth of the wearer is positioned in closely spaced relationship with the circular opening 50 of the mask 5 to reduce the dead space volume.” Column 8, Lines 40-55) in the facemask, and means for actively reducing dead space of the facemask cup (via operation of 11/12 as connected to 5, “The respiratory apparatus 1 generally comprises a face mask or face piece 5, an airflow tubing assembly 6 and a face mask securing mean which in the illustrated embodiment comprises a flexible skull cap 10, adjustable securement straps 11 and strap fasteners 12.” Column 4, Lines 40-55 whereby “When the mask 5 is positioned against the face of a user and the straps 11 are appropriately adjusted, the straps 11 pull the mask 5 against the face so as to generally advance the sealing flange 34 against the inner surface 21 of the mask 5 so as to significantly reduce the amount of dead space in the mouth-enclosing chamber 29 while forming an airtight seal between the sealing flange 34 and the face of the user.” Column 8, Lines 1-20).
Claims 10, 12, 13, and 18-20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Thornton (2005/0016544).
As to Claim 10, Thornton discloses a pliable adult facemask (Figure 5), comprising: a facemask cup (12, “Mask 12 includes a perimeter 14 and holes 16, one for each of the user's nostrils, into which fittings 18 may be inserted during or after formation and fitting of mask 12.” Para 0013) defining a convex shaped outer surface (defined by the portion of 12 exposed to the ambient environment), an inner surface (defined by the portion of 12 which abuts the face of the user) of the facemask cup (12) configured to cover a mouth of the wearer via a mouth covering region (12 near lower 24) of the facemask cup (12) and nostrils of the wearer via a nose covering region (12 near 16) of the facemask cup (12); an inlet tube (18, “Mask 12 includes a perimeter 14 and holes 16, one for each of the user's nostrils, into which fittings 18 may be inserted during or after formation and fitting of mask 12. Fittings 18 may be used to couple mask 12 to an external system 20, such as a continuous positive air pressure (CPAP) system, for supplying air or another gas to the user's nose at positive pressure to help open the user's breathing passage and thereby improve the user's breathing. For example, system 10 may include tubes 22 that snap onto, are force fitted onto, or otherwise couple to fittings 18.” Para 0013) extending from the facemask outer surface (defined by the portion of 12 exposed to the ambient environment) to a distal tube aperture (22) along the inlet tube (18) via a proximal aperture (16) in the facemask (Figure 5), at least 80% of an interior of the facemask cup (12) is within one eighth of an inch from a human face.
Regarding the “at least 80% … one eight of an inch” limitation, 1lthough Thornton does not expressly disclose the configuration whereby “at least 80% of an interior surface of the facemask is configured to be within one eighth of an inch from a human face.” The inherent nature of the mask forming a molded copy of the unique anatomy of the user’s face would provide an interior surface whereby at least 80% of the facemask is within 1/8 inch from the user’s face.
As to Claim 18, Thornton discloses a pliable adult facemask (Figure 5), comprising: a facemask cup (12, “Mask 12 includes a perimeter 14 and holes 16, one for each of the user's nostrils, into which fittings 18 may be inserted during or after formation and fitting of mask 12.” Para 0013) that is essentially defined by a nose covering region (12 near 16), a mouth covering region (12 near lower 24), two cheek covering regions (defined by the lateral portions of 16 from the nose covering region near 16) , and perimeter (14, “a perimeter 14” Para 0013), the perimeter (14) essentially defined by a nose bridge rim (14 vertically upward from the nose covering region near 16), two cheek rims (14 lateral from the lateral portions of 16 from the nose covering region near 16) and a chin rim (vertical downward from the mouth covering region near lower 24), the nose covered region (12 near 16) configured to closely conform to an adult human nose (“Mask 12 is preferably formed and fitted to the user's face so as to conform substantially optimally to the user's unique bone structure and facial features, including at least a portion of the user's nose surrounding the user's nostrils.” Para 0014), the mouth covering region (12 near lower 24) configured to be in front of an adult human mouth (best seen Figure 5), the cheek covering regions (defined by the lateral portions of 16 from the nose covering region near 16) configured to at least partially contact a corresponding side of an adult human cheek (best seen figure 5); an inlet tube (18, “Mask 12 includes a perimeter 14 and holes 16, one for each of the user's nostrils, into which fittings 18 may be inserted during or after formation and fitting of mask 12. Fittings 18 may be used to couple mask 12 to an external system 20, such as a continuous positive air pressure (CPAP) system, for supplying air or another gas to the user's nose at positive pressure to help open the user's breathing passage and thereby improve the user's breathing. For example, system 10 may include tubes 22 that snap onto, are force fitted onto, or otherwise couple to fittings 18.” Para 0013) outwardly extending from the adult facemask, the inlet tube (18) generally defined by a passageway (lumen of 18) that leads through distal aperture (22) and nose aperture (16) in the facemask (Figure 5); and means for actively reducing dead space of the facemask cup (defined by the cooperative operation of 24 and 26, “Mask 12 may include buckles or other devices 24 to couple mask 12 to one or more straps 26, which may help secure mask 12 to the user's face during use. Devices 24 may be coupled to mask 12 during or after formation and fitting of mask 12. Although straps 26 are described as an example, mask 12 being secured in any appropriate manner.” Para 0013).
As to Claims 12 and 19, Thornton discloses the conformity of the facemask by the use of a thermoplastic blank which forms a custom mask of the user’s face (Para 0022), thereby achieving a mask that is “substantially optimally to the user's unique bone structure and facial features” of the user (Para 0014). Although Thornton does not expressly disclose the numerical value to be NO “more than 0.35 inches from a human face”. The inherent nature of the mask forming a molded copy of the unique anatomy of the user’s face would be NO “more than 0.35 inches” from the face of the user.
As to Claims 13 and 20, Thornton discloses the conformity of the facemask by the use of a thermoplastic blank which forms a custom mask of the user’s face (Para 0022), thereby achieving a mask that is “substantially optimally to the user's unique bone structure and facial features” of the user (Para 0014). Although Thornton does not expressly disclose the configuration whereby “at least 90% of an interior surface of the facemask is configured to be within one eighth of an inch from a human face.” The inherent nature of the mask forming a molded copy of the unique anatomy of the user’s face would provide an interior surface whereby at least 90% of the facemask is within 1/8 inch from the user’s face.
Claim 18 is rejected under 35 U.S.C. (a)(2) as being anticipated by Davis (2014/0261430).
As to Claim 18, Davis discloses a pliable adult facemask (Figures 1-3), comprising: a facemask cup (best seen Figures 1-3) that is essentially defined by a nose covering region (proximate nose of user), a mouth covering region (proximate mouth of user), two cheek covering regions (defined by the lateral extension from the nose to the ears) and a perimeter (defined by the outer circumference of the mask proximate the hairline, ears, and neck), the perimeter (defined by the outer circumference of the mask proximate the hairline, ears, and neck) essentially defined by a nose bridge rim (Figure 1 “Root of nose”), two cheek covering rims (proximate the ears), and a chin rim (proximate the neck), the nose covering region (proximate nose of user) shaped to closely conform to an adult human (best seen Figures 1-3), the mouth covering region (proximate mouth of user) configured to be in front of an adult human mouth (best seen Figures 1-3), the cheek covering regions (defined by the lateral extension from the nose to the ears) configured to at least partially contact a corresponding side of the an adult human cheek; an inlet tube (best seen Figures 1-3) extending from the adult facemask, the inlet tube generally defined by a passageway (via “breathing tube” Para 0026 and 0029) that leads through distal aperture (via source of “oxygen” Para 0029) and nose aperture defined by opening in the facemask cup) in the facemask (Figures 1-3); and means for actively reducing dead space of the facemask cup (“including strap attachments and at least one strap for securing the mask portion to the face, wherein the at least one strap is sized to extend around the user's head and for applying a pressure distributed across the contoured facial mask portion, wherein the pressure is distributed substantially uniformly across the contoured facial mask portion that contacts the user's face.” Para 0028).
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 3, 4, 10, 12, 13, 17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rudolph (5,265,595).
As to Claims 3, 12, and 19, Rudolph discloses a reduced dead space adult facemask (Figures 1-3) configured to encompass the nose and mouth of the user by a facemask cup (5), with an interior portion having an interior surface (defined by the region of 5 which is proximate to the nose and mouth of the user) that appears to abut the nose and mouth of the user as best shown in Figure 3; yet, does not expressly disclose “wherein no part of an interior portion of the facemask cup is configured to be more than 0.35 inch from a human face.”
In light of the relationship between the dead space volume and the distance of the facemask cup to the facial features of the user, it would have been obvious to one having ordinary skill in the art to select the distance between the facemask cup and the face of the user to meet the claimed configuration of NO “more than 0.35 inch from the human face”, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimal or workable ranges involves only routine skill in the art.
As the construction of the interior surface of the facemask appears to abut the face of the user as shown in Rudolph’s Figure 3, the claimed value of NO “more than 0.35 inch from the human face” would have been obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to achieve the “more preferably below 36 milliliters” (Column 8, Lines 45-60) as stated by Rudolph for the purpose of securing the facemask to the face of the user so as to “reduce the dead space volume” (Column 8, Lines 45-60).
Moreover, Applicant has not asserted the specific claimed configuration of NO “more than 0.35 inch from the human face” provides a particular advantage, solves a stated problem or serves a particular purpose different from that of reducing the dead space volume between the face of the user and the facemask cup; thus, the use of the specific claimed configuration of NO “more than 0.35 inch from the human face” appears to lack criticality in its design. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with Rudolph, as the construction would yield the predictable results of providing a reduction in dead space volume between the facemask cup and the face of the user.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the distance of the interior of the facemask cup to the human face of Rudolph to meet the claimed configuration of NO “more than 0.35 inch from the human face”, a known result effective variable, in order to reduce the dead space volume of the facemask.
As to Claims 4, 13, and 20, Rudolph discloses a reduced dead space adult facemask (Figures 1-3) configured to encompass the nose and mouth of the user by a facemask cup (5), with an interior portion having an interior surface (defined by the region of 5 which is proximate to the nose and mouth of the user) that appears to abut the nose and mouth of the user as best shown in Figure 3; yet, does not expressly disclose “wherein at least 90% of an interior portion of the facemask cup is configured to be within one eighth of an inch from a human face.”
In light of the relationship between the dead space volume and the distance of the facemask cup to the facial features of the user, it would have been obvious to one having ordinary skill in the art to select the distance between the facemask cup and the face of the user to meet the claimed configuration of “within one eighth of an inch from a human face”, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimal or workable ranges involves only routine skill in the art.
As the construction of the interior surface of the facemask appears to abut the face of the user as shown in Rudolph’s Figure 3, the claimed value of “within one eighth of an inch from a human face” would have been obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to achieve the “more preferably below 36 milliliters” (Column 8, Lines 45-60) as stated by Rudolph for the purpose of securing the facemask to the face of the user so as to “reduce the dead space volume” (Column 8, Lines 45-60).
Moreover, Applicant has not asserted the specific claimed configuration of “within one eighth of an inch from a human face” provides a particular advantage, solves a stated problem or serves a particular purpose different from that of reducing the dead space volume between the face of the user and the facemask cup; thus, the use of the specific claimed configuration of “within one eighth of an inch from a human face” appears to lack criticality in its design. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with Rudolph, as the construction would yield the predictable results of providing a reduction in dead space volume between the facemask cup and the face of the user.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the distance of the interior of the facemask cup to the human face of Rudolph to meet the claimed configuration of “within one eighth of an inch from a human face”, a known result effective variable, in order to reduce the dead space volume of the facemask.
As to Claim 10, Rudolph discloses a pliable adult facemask (Figures 1-3, “This invention relates to an oral respiratory mask to provide breath-by-breath measurements of respiration and metabolism in adults or children.” Column 1, Lines 15-25; “the present invention provides a mask which, because of its curvature and flexibility, may be used to provide highly accurate breath-by-breath measurements of respiration and metabolism in adults and children.” Column 2, Lines 20-30; “The present invention consists primarily of a respiratory mask having a relatively very small minimum dead air space, a unique directional airflow regulating system and a face-sealing surface constructed for superior facial fit on both adults and children.” Column 2, Lines 30-40; “to provide such a face mask which is effective for use on adults or children” Column 3, Lines 30-55; also see: “The face mask 5 is constructed of silicone or other like material that is preferably flexible and yet resilient and that does not cause substantial skin irritation to the user.” Column 4, Lines 50-65), comprising: a facemask cup (5, “The respiratory apparatus 1 generally comprises a face mask or face piece 5, an airflow tubing assembly 6 and a face mask securing mean which in the illustrated embodiment comprises a flexible skull cap 10, adjustable securement straps 11 and strap fasteners 12. The face mask 5 is constructed of silicone or other like material that is preferably flexible and yet resilient and that does not cause substantial skin irritation to the user. The face mask 5 is a cup-like structure having an outer surface 20 and an inner surface 21 and positionable on the face of a user so as to generally encircle and enclose the nose and mouth of the user. An endless outer peripheral edge 22 of the face mask 5 is shaped to conform with the shape of the face of an average user of the mask and generally conforms to the shape of the face upon which the mask 5 is secured. ” Column 4, Lines 40-65) defining a convex shaped outer surface (defined by the portion of 5 anterior to the facemask cup and exposed to the ambient environment), an inner surface (defined by the portion of 5 posterior to the facemask cup and encompassing the nose and mouth of the user) of the facemask cup (5) configured to cover a mouth of a wearer (best seen Figure 3) via a mouth covering region (29, “A separating wall 27 extends across the inner surface of the face mask 5 so as to separate the volume enclosed by the mask 5 when secured to a wearer's face into a nose-enclosing chamber 28 and a mouth-enclosing chamber 29.” Column 4, Line 60 thru Column 5, Line 15) of the facemask cup (5) and nostrils of the wearer (best seen Figure 3) via a nose covering region (28, “A separating wall 27 extends across the inner surface of the face mask 5 so as to separate the volume enclosed by the mask 5 when secured to a wearer's face into a nose-enclosing chamber 28 and a mouth-enclosing chamber 29.” Column 4, Line 60 thru Column 5, Line 15) of the facemask cup (5); an inlet tube (114, “an inhalation intake tube 114 having an inhalation intake passageway 115 extending therethrough is threadingly secured to the Y-branched tube 95 so that the inhalation intake passageway 115 extends in axial alignment and in flow communication with the inhalation airflow passageway 98.” Column 6, Lines 20-40) extending from the facemask outer surface (defined by the portion of 5 anterior to the facemask cup and exposed to the ambient environment) to a distal tube aperture (115, “inhalation intake passageway 115” Column 6, Lines 20-40), the inner surface (defined by the portion of 5 posterior to the facemask cup and encompassing the nose and mouth of the user) is in communication with the distal tube aperture (115) along the inlet tube (114) via a proximal aperture (50, “A circular opening 50 extends through the face mask 5 so as to flow communicate with the mouth-enclosing chamber 29.” Column 5, Lines 30-60; also see: “The mask 5 is positioned so that the mouth opening of the user is flow aligned with the circular passageway 50 in the mask 5 and the common airflow passageway 96 in the airflow tubing assembly 6.” Column 8, Lines 5-20 and “When the mask 5 is secured in position, the mouth of the wearer is positioned in closely spaced relationship with the circular opening 50 of the mask 5 to reduce the dead space volume.” Column 8, Lines 40-55) in the facemask (Figures 1-3).
Yet, does not expressly disclose “wherein at least 80% of an interior portion of the facemask cup is configured to be within one eighth of an inch from a human face.”
In light of the relationship between the dead space volume and the distance of the facemask cup to the facial features of the user, it would have been obvious to one having ordinary skill in the art to select the distance between the facemask cup and the face of the user to meet the claimed configuration of “within one eighth of an inch from a human face”, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimal or workable ranges involves only routine skill in the art.
As the construction of the interior surface of the facemask appears to abut the face of the user as shown in Rudolph’s Figure 3, the claimed value of “within one eighth of an inch from a human face” would have been obvious to try choosing from a finite number of identified and predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to achieve the “more preferably below 36 milliliters” (Column 8, Lines 45-60) as stated by Rudolph for the purpose of securing the facemask to the face of the user so as to “reduce the dead space volume” (Column 8, Lines 45-60).
Moreover, Applicant has not asserted the specific claimed configuration of “within one eighth of an inch from a human face” provides a particular advantage, solves a stated problem or serves a particular purpose different from that of reducing the dead space volume between the face of the user and the facemask cup; thus, the use of the specific claimed configuration of “within one eighth of an inch from a human face” appears to lack criticality in its design. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with Rudolph, as the construction would yield the predictable results of providing a reduction in dead space volume between the facemask cup and the face of the user.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the distance of the interior of the facemask cup to the human face of Rudolph to meet the claimed configuration of “within one eighth of an inch from a human face”, a known result effective variable, in order to reduce the dead space volume of the facemask.
As to Claim 17, Rudolph discloses a facemask cup volume that is essentially defined by a maximum amount of water the facemask cup can hold, the facemask cup volume less than 5 cubic inches (“Preferably the gas volume in the chamber 29 of the mask apparatus 1 is below approximately 125 milliliters and even more preferably below 36 milliliters.” Column 8, Lines 50-60).
Regarding the limitation “a facemask cup volume that is essentially defined by a maximum amount of water the facemask cup can hold”, although Applicant utilizes “water” as the medium by which the volume is measured, the disclosure of Rudolph effectively meets the limitations of the claims as the disclosed medium of “gas” encompasses the same shape. Hence, Applicant’s reliance on the “amount of water” does not affect the volume as the shapes and thus containment structure upon which the medium is remains the same.
Regarding the “less than 5 cubic inches”, the disclosed “more preferably below 36 milliliters” of Rudolph converts to approximately 2.197 cubic inches. Thus, Rudolph’s volume meets the limitations of being “less than 5 cubic inches”.
Thus, Rudolph appears to meet the limitations of the claims.
Claims 2, 5-7, 11, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rudolph (5,265,595) in view of Gradon et al. (2002/0005201).
As to Claims 2 and 11, Rudolph discloses headgear (via operation of 11/12 as connected to 5, “The respiratory apparatus 1 generally comprises a face mask or face piece 5, an airflow tubing assembly 6 and a face mask securing mean which in the illustrated embodiment comprises a flexible skull cap 10, adjustable securement straps 11 and strap fasteners 12.” Column 4, Lines 40-55 whereby “When the mask 5 is positioned against the face of a user and the straps 11 are appropriately adjusted, the straps 11 pull the mask 5 against the face so as to generally advance the sealing flange 34 against the inner surface 21 of the mask 5 so as to significantly reduce the amount of dead space in the mouth-enclosing chamber 29 while forming an airtight seal between the sealing flange 34 and the face of the user.” Column 8, Lines 1-20) to secure the facemask to the face of the user; yet, does not expressly disclose “at least one strap anchor between the inlet tube and the mouth covering region configured to retain a head retention strap, the strap anchor is less than 1.25 inches from a facemask midline defined as extending along the center of the facemask bisecting the nose covering region and the mouth covering region.”
Gradon teaches an alternative closely conforming facemask (best seen Figures 5-7) having a pliable facemask cup (102, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3. … The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033; “Referring now to FIGS. 4 and 5 the headgear 108 is shown connected to the hollow body 102. Rather than traditional fixed or adjustable attachments the present invention utilises a sliding engagement between the headgear 108 and the hollow body 102. This is achieved with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102. The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102.” Para 0035; “In a further embodiment shown in FIGS. 6, 7 and 8 the present invention is illustrated using a sliding strap to attach the headgear 108 to the hollow body 102. The strap 200, shown in FIG. 8 in isolation, is constructed of polyacetal (Delrin 500P NC010) using injection moulding techniques to give a polished finish. This material, similar to other nylon based derivatives, with its polished finish has a particularly low friction co-efficient, and therefore slides with respect to the hollow body 102 with very little resistance.” Para 0039; and “As shown in FIG. 6, the hollow body 102 includes a number of engaging clips 202, in use the sliding strap 200 snaps into place into the engaging clips 202 and can only be removed therefrom using a substantial force. This means that with any normal use the sliding strap 200 will stay retained within the engaging clips 202. It will also be appreciated from FIG. 6 that a number of clips are so provided, in order to allow pressure from different angles for different face shapes.” Para 0040) a distal tube port (3, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3.” Para 0033) in communication with a nasal aperture (via 103, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3.” Para 0033); and a facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7, wherein 120 – “This is achieved with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102. The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102. … Additional guides 129, 130, 131 allow the user to adjust position of loop 120, giving ability to get different pressure on the seal depending on loop 120 position.” Paras 0035 and 0037; and wherein 200 – “In a further embodiment shown in FIGS. 6, 7 and 8 the present invention is illustrated using a sliding strap to attach the headgear 108 to the hollow body 102. The strap 200, shown in FIG. 8 in isolation, is constructed of polyacetal (Delrin 500P NC010) using injection moulding techniques to give a polished finish. This material, similar to other nylon based derivatives, with its polished finish has a particularly low friction co-efficient, and therefore slides with respect to the hollow body 102 with very little resistance. As shown in FIG. 6, the hollow body 102 includes a number of engaging clips 202, in use the sliding strap 200 snaps into place into the engaging clips 202 and can only be removed therefrom using a substantial force. This means that with any normal use the sliding strap 200 will stay retained within the engaging clips 202. It will also be appreciated from FIG. 6 that a number of clips are so provided, in order to allow pressure from different angles for different face shapes.” Paras 0039 and 0040) disposed on the face covering cap (102) proximate the nasal tube (103).
Regarding the concept of the “between the inlet tube and the mouth covering region”, the mask of Gradon is explicitly described for nasal only applications as best seen in Figure 4. Consequently, the orientation of the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) are located between the inlet tube (103) and the mouth covering region as the mouth covering region is beyond and below the pliable facemask cup (102) of Gradon.
Regardless of Gradon’s nasal only facemask cup application, the teachings of Gradon with respect to the placement and orientation of the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) remain a feature which would be obvious to modify the facemask of Rudolph, for the purpose of achieving variable pressure points for sealing engagement of the facemask to conform to the face of the user – in order to “allow the user to adjust position of loop 120, giving ability to get different pressure on the seal depending on loop 120 position.” (Para 0037) and “to allow pressure from different angles for different face shapes.” (Para 0040).
In light of the teaching of Gradon, the decision to modify the facemask of Rudolph to include the facemask retention strap between the nasal tube and along the centerline of the facemask proximate the mouth, 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 vary the sealing pressures applied to Rudolph as modified by Gradon to better conform to the anatomical features of the patient wearing the facemask.
Applicant has not asserted this specific orientation “between the nasal tube and the mouth center point” provides a particular advantage, solves a stated problem, or serves a particular purpose different from the ability to effectively seal the facemask to the face of the user; thus, the use of the specific orientation of “between the nasal tube and the mouth center point” appears to lack criticality in its design. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Rudolph, as the construction of the facemask retention straps “between the inlet tube and the mouth covering region” would yield the predictable results of providing variable pressure points suitable to conform the facemask to seal to the anatomical features of the patient wearing the facemask.
Regarding the “at least one strap anchor”, Gradon teaches at least one anchor (126/129/130/128/131 of Figures 4 and 5; 202 of Figures 6 and 7, wherein 126/129/130/128/131 – “The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102. … Additional guides 129, 130, 131 allow the user to adjust position of loop 120, giving ability to get different pressure on the seal depending on loop 120 position.” Paras 0035 and 0037; and wherein 202 – “As shown in FIG. 6, the hollow body 102 includes a number of engaging clips 202, in use the sliding strap 200 snaps into place into the engaging clips 202 and can only be removed therefrom using a substantial force. This means that with any normal use the sliding strap 200 will stay retained within the engaging clips 202. It will also be appreciated from FIG. 6 that a number of clips are so provided, in order to allow pressure from different angles for different face shapes.” Para 0040) extending from the facemask (Figures 4-7) that retain the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) between the nasal tube and the mouth center point. As indicated, the anchors (126/129/130/128/131 of Figures 4 and 5; 202 of Figures 6 and 7) provide for a series of placement orientations along the body of the facemask upon which the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) engages to permit variability of pressures for sealing engagement of the facemask to conform to the face of the user.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the location of the facemask retention strap of Rudolph to extend between the inlet tube and the mouth covering region via at least one strap anchor, a known result effective variable and as taught by Gradon to be a known orientation suitable for imparting variable pressure points for sealing engagement of the facemask to conform to the face of the user.
As to Claims 5 and 14, the modified Rudolph, specifically Gradon teaches the configuration of a head strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) that crosses over a facemask midline between the inlet tube (103) and the mouth covering region, the facemask midline is defined as extending along the center of the facemask bisecting the nose covering region and the mouth covering region.
As to Claims 6 and 15, the modified Rudolph, specifically Gradon teaches at least one anchor (126/129/130/128/131 of Figures 4 and 5; 202 of Figures 6 and 7) is within 1.25 inches from a facemask midline, which is defined as extending along the center of the facemask bisecting the nose covering region and the mouth covering region, wherein the strap portion (120 of Figures 4 and 5; 200 of Figures 6 and 7) span between two head strap anchors (126/129/130/128/131 of Figures 4 and 5; 202 of Figures 6 and 7) that are between the inlet tube (103) and the mouth covering region. As shown in Figure 4 and 5, each of the anchors (126/129/130/128/131 of Figures 4 and 5) extend contiguously in a lateral direction across the facemask midline, whereby the claimed “within 1.25 inches” is an inherent configuration. As shown in Figure 6 and 7, the anchors (202 of Figures 6 and 7) are oriented in a mirrored pattern along the facemask midline, wherein the configuration of the claimed “within 1.25 inches” 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 achieve the desired variability in sealing pressures along the facemask.
As to Claim 7, the modified Rudolph, specifically Gradon teaches the head strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) is a contiguous elastic band (as best seen in Figures 4 and 5), there is contagiousness of head strap (120).
Claims 9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Rudolph (5,265,595) in view of Matsubara et al. (10,058,672).
As to Claims 9 and 16, Rudolph discloses two cheek rims (via 34/34 laterally extending from the nose covering region 28) extending away from the mouth covering region (28); yet does not expressly disclose the extension “in an elongated flared lateral touch region that is at least one inch at a right angle from a vertical reference line defined by a 90° reference angle that passes through a bridge rim apex of the face mask nose bridge rim along a Y-axis and a chin rim apex of the chin rim along a X-axis.”
Matsubara teaches a nasal directed flow facemask (Figures 1 and 2), comprising: a pliable facemask cup (6, “As shown in FIGS. 2 and 5, an oxygen mask apparatus 1 as a gas supply mask apparatus includes a mask main body 6 capable of covering a substantially central portion (more specifically, a nose 4 and a mouth 5 and their peripheries) of a face 3 of a mask wearer 2 such as a patient. Note that the mask main body 6 can integrally be molded from a substantially transparent (in other words, light-transmitting) soft synthetic resin such as soft vinyl chloride so as to have a substantially bisymmetrical shape and substantially bisymmetrical pattern.” Column 5, Lines 15-45) that is essentially defined by a nose covering region (defined by the portion of 6 which covers “nose 4” and is proximate 11c, Column 5, Lines 15-45), a mouth covering region (defined by the portion of 6 which covers “mouth 5” and is proximate 11d, Column 5, Lines 15-45), two cheek covering regions (defined by the portion of 6 which covers the remainder of the “face 3” of the patient and is proximate 11a and 11b, Column 5, Lines 15-45), and a perimeter (11, “At least left and right side portions 11a and 11b of an outer peripheral portion 11 of the mask main body 6 are so formed as to form a substantially flat surface over a substantially whole region (in other words, a substantially horizontal surface is formed when the mask main body 6 is placed upward on a horizontal surface 7 as shown in FIG. 5). Note that an upper side portion 11c of the outer peripheral portion 11 has a curved shape which slightly projects forward (in other words, outward), so as to substantially fit the shape of the nose 4 of the mask wearer 2. A lower side portion 11d of the outer peripheral portion 11 forms a substantially flat surface which substantially continues to the left and right side portions 11a and 11b, so as to substantially fit a portion (and the vicinity) above a chin 12 of the mask wearer 2. However, the lower side portion 11d may also have a curved shape which slightly projects forward (in other words, outward), so as to substantially fit a portion (and the vicinity) below the chin 12 of the mask wearer 2.” Column 5, Lines 15-45), the perimeter (11) essentially defined by a nose bridge rim (11c, “Note that an upper side portion 11c of the outer peripheral portion 11 has a curved shape which slightly projects forward (in other words, outward), so as to substantially fit the shape of the nose 4 of the mask wearer 2.” Column 5, Lines 15-45), two cheek rims (11a and 11b, “At least left and right side portions 11a and 11b of an outer peripheral portion 11 of the mask main body 6 are so formed as to form a substantially flat surface over a substantially whole region (in other words, a substantially horizontal surface is formed when the mask main body 6 is placed upward on a horizontal surface 7 as shown in FIG. 5). … A lower side portion 11d of the outer peripheral portion 11 forms a substantially flat surface which substantially continues to the left and right side portions 11a and 11b, so as to substantially fit a portion (and the vicinity) above a chin 12 of the mask wearer 2.” Column 5, Lines 15-45), and a chin rim (11d, “A lower side portion 11d of the outer peripheral portion 11 forms a substantially flat surface which substantially continues to the left and right side portions 11a and 11b, so as to substantially fit a portion (and the vicinity) above a chin 12 of the mask wearer 2.” Column 5, Lines 15-45), the nose covering region (defined by the portion of 6 which covers “nose 4” and is proximate 11c) shaped to closely conform to the human nose (4), the mouth covering region (defined by the portion of 6 which covers “mouth 5” and is proximate 11d) configured to be in front of the human mouth (5), the cheek covering regions (defined by the portion of 6 which covers the remainder of the “face 3” of the patient and is proximate 11a and 11b) configured to at least partially contact corresponding sides of a human cheek (the lateral peripheries of the “face 3” remote form the midsagittal region); an inlet tube (31/32 via 33, “As shown in, e.g., FIGS. 1 and 5, in a portion slightly below a substantially central portion of the mask main body 6, a connector attaching portion 33 for attaching first and second connectors 31 and 32 is formed.” Column 6, Lines 50 thru Column 7, Line 20; also see: “As shown in, e.g., FIGS. 1 and 5, the oxygen mask apparatus 1 includes the first connector 31, the second connector 32, a third connector 43, a gas supply tube 44, and a fourth connector (not shown).” Column 7, Line 20 thru Column 8, Line 10) outwardly extending from the facemask (Figures 1 and 2), the inlet tube (31/32 via 33) generally defined by a passageway (defined by the lumens of 31/32) that leads through a distal aperture (via 44 as connected to 43, 32, and 31, “a gas supply tube 44” Column 7, Line 20 thru Column 8, Line 10) and a proximal nose aperture (via 51 of 31, “Also, a substantially circular opening 51 for introducing oxygen (in other words, for introducing a gas to the inside of the mask main body 6) is formed in a substantially central portion of the substantially pyramidal upper-end surface portion 46.” Column 7, Line 20 thru Column 8, Line 10; also see: “Also, in the embodiment shown in the drawings, the gas introduction opening 51 of the first connector 31 has a diameter of approximately 3 mm, and an opening area of approximately 7 mm.sup.2, which indicates the size of the opening 51. Column 8, Lines 10-25) in the facemask (Figures 1 and 2).
Regarding the remaining limitations of the claims, Matsubara discloses two cheek rims (11a and 11b) at the two cheek covering regions (defined by the portion of 6 which covers the remainder of the “face 3” of the patient and is proximate 11a and 11b, Column 5, Lines 15-45) extending away from the mouth covering region (defined by the portion of 6 which covers “mouth 5” and is proximate 11d, Column 5, Lines 15-45) in an elongated flared lateral touch region (via U shape at the rim (11) best seen Figure 1; also see: Figure 5, wherein “. At least left and right side portions 11a and 11b of an outer peripheral portion 11 of the mask main body 6 are so formed as to form a substantially flat surface over a substantially whole region (in other words, a substantially horizontal surface is formed when the mask main body 6 is placed upward on a horizontal surface 7 as shown in FIG. 5).” Column 5, Lines 15-50) to a cheek rim (11a and 11b) at a right angle (via U shape) from a vertical reference line by a 90 degree reference angle that passes through a facemask nose bridge rim apex (via U shape at 11c) along the Y-axis and the chin rim apex (via U shape at 11a and 11b) along the X axis.
In light of the relationship of cheek rims (11a and 11b) to provide sealing engagement along the human cheek (the lateral peripheries of the “face 3” remote form the midsagittal region) of the patient, it would have been obvious to one having ordinary skill in the art to select the specific length of the claimed elongated flared lateral touch region to be consistent with the known anatomical features of the general demographics of the human patient.
By the consideration of the “upward” shape as shown in Figure 5, Matsubara appears to consider that the general demographics of the human patient includes the features of cheeks which extend anterior to the position of the mouth whilst in line with the philtrum of the nose of the patient to conform to a human patient by enabling a seal between the facemask and the face of the patient.
Consequently, the specific length as claimed to be “at least one inch” 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 of the “elongated flared lateral touch region” to form a seal between the facemask and the face of the patient. Hence, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with Matsubara as the length of the “elongated flared lateral touch region” would yield the predictable results of forming a seal between the facemask and the face of the patient.
Moreover, Applicant has not asserted the specific “at least one inch in length” dimension of the “elongated flared lateral touch region” provides a particular advantage, solves a stated problem, or serves a particular purpose different from that of providing a sealing surface upon which the facemask may be sealed to the face of the patient; thus, the specific dimensions of “at least one inch in length” appears to lack criticality in its design.
Therefore, it would have been obvious to one having ordinary skill in the art to modify cheek rims of Rudolph to be the explicit length of the “elongated flared lateral touch region” to be “at least one inch in length” as claimed, a known result effective variable, in order to permit the sealing engagement of the facemask to the face of the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hinkle (4,896,666) discloses a facemask for a child in need of a pacifier and discusses the importance of reducing dead space volume.
Schneider et al. (2008/0092898) discloses a facemask for an adult user (Para 0026) encompassing the nose and mouth of the user (Para 0032) and discusses the importance of the facemask having a reduced dead space volume “less than 20 mL” for the purpose “to maintain patient comfort and minimize rebreathing of exhalation” (Para 0074).
Chang (2016/0030695) discloses a facemask for a user encompassing the nose and mouth of the user (Para 0078) and discusses the importance of dead space volume as compared to the waste of oxygen in other conventional patient interfaces (Paras 0107-0118).
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
Prosecution Insights