DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-15, drawn to a face mask.
Group II, claim(s) 16-18, drawn to a method for securing a mask.
Group III, claim(s) 19 and 20, drawn to a method of assembling a face mask
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II, and Group III and II, lack unity of invention because even though the inventions of these groups require the technical feature of a mask body with at least two nasal prongs disposed therein, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Turnberg (US 2,663,297), which discloses a mask body (body 12) with nasal prongs (elements 31 of nasal cannula 30) disposed therein (Fig. 1). See also Ziaee and Amarasinghe, discussed below, which also disclose these elements. This raises an objection of lack of unity a posteriori, wherein a mask body with at least two nasal prongs disposed therein is not a technical feature that defines a contribution over the prior art.
Groups I and III lack unity of invention because even though the inventions of these groups require the technical feature of a mask body that covers at least the nostrils of a subject that includes at least two inlet ports, at least two tubes fluidly coupled to at least two transition features that are fluidly coupled to at least two nasal prongs, wherein the at least two tubes or transition features pass through the at least two inlet ports, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Ziaee (US 2002/0053347 A1), which discloses a mask body (shell 21) (Figs. 1, 5 and 12-14) that covers at least the nostrils of a subject (Fig. 12) that includes at least two inlet ports (openings 31), at least two at least partially external tubes (air supply hoses 58 and/or tubular portions 32) (Figs. 5 and 12; para [0030] or [0046]) fluidly coupled to at least two at least partially internal transition features (comprising members 23) that are fluidly coupled to at least two nasal prongs (Figs. 1, 4, 5 and 15; para [0043]), wherein the at least two tubes or transition features pass through the at least two inlet ports (Figs. 1, 5 and 15). See also Amarasinghe, discussed below, which also discloses these elements. This raises an objection of lack of unity a posteriori, wherein a mask body that covers at least the nostrils of a subject that includes at least two inlet ports, at least two at least partially external tubes fluidly coupled to at least two at least partially internal transition features that are fluidly coupled to at least two nasal prongs, wherein the at least two tubes or transition features pass through the at least two inlet ports is not a technical feature that defines a contribution over the prior art.
During a telephone conversation with Harmonhinder Bedi on 2/23/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Novel Face Masks With Internal Nasal Prongs and Methods Relating Thereto
Claim Objections
Claims 1-4, 6, 8-11, 13 are objected to because of the following informalities:
Regarding claims 1-4, 6, 8, 11 and 13, the claims should be amended to read “configured to” in all instances (15 instances) to make it clearer that structural considerations are being recited, rather than indefinite mental steps
Claim 1, line 17 should read “within a nasal cavity”
Claim 1, line 20 should read “of the at least two of said tubes” for clarity, because it is understood to be referring to that of line 19
Claim 1, line 22 should read “of the at least two of said tube transition features” for clarity, because it is understood to be referring to that of lines 20-21
Claims 9 and 10 should be amended to read “wherein the at least two…pass through the at least two of said inlet ports such that [said] portions of the at least two…wherein the at least two…respective ones of the at least two of said inlet ports” to make it clearer that the elements are being positively recited, rather than conditionally recited, and that they are referring to those of claim 1
Claim 10, line 3 should read “features are”
Claim 11, line 2 may have been intended to read “and of”
Appropriate correction is required.
Claim Interpretation
An “embedded” filtration element per claims 12-13 is understood to mean one that is positioned within a mask port.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1 (and thus its dependent claims), lines 10-11 recite “said tube…said tube transition feature” but line 8 recites “at least two tube transition features,” line 6 recites “at least two tubes,” and lines 8-9 recites “at least one of said tubes”, such that it is unclear to which tube and which transition feature lines 10-11 are referring. As best understood, for purposes of examination, the claim will be considered to read “from said at least one of said tubes
Regarding claim 1 (and thus its dependent claims), lines 12-13 recite “said tube transition feature” but line 8 recites “at least two tube transition features” and lines 12-13 recites “at least one of said tube transition features”, such that it is unclear to which transition feature lines 12-13 are referring. As best understood, for purposes of examination, the claim will be considered to read “said at least one of said tube transition features”.
Further regarding claim 1, lines 16-18 recites at least two terminating features “each of which is disposed around said nasal prongs…said nasal prongs within [a] nasal cavity inside the nostril [note: “the nostril” lacks antecedent basis]” (emphasis added) but it understood from the specification as originally filed, see e.g. instant Fig. 2, that each terminating feature is only associated with one of the nasal prongs, not both of the nasal prongs, and each nasal prong is associated with one of two nostrils. As best understood, for purposes of examination, the claim will be considered to read “each of which is disposed around one of said nasal prongs…said one of said nasal prongs within [a] nasal cavity inside a nostril”.
Regarding claim 4 (and thus its dependent claim 5), lines 1 and 6-7 recite “at least two of said tubes” wherein it is unclear whether these two instances of “at least two” refer to the same two, and it is unclear if either or both instances are the same “at least two” from claim 3, or the same “at least two” as claim 1, lines 19-20, or whether they are all the same or different. As best understood, for purposes of examination, the “at least two” tubes in claim 4 are the same and are the same as in claim 3, but not necessarily the same two as in claim 1.
Regarding claim 4 (and thus its dependent claim 5), line 5 recites “said circumferential clip” but line 3 recites a circumferential clip disposed around each of at least two tubes, i.e. claim 3 recites at least two clips, such that it is unclear to which clip line 3 is referring. For purposes of examination, the claim will be considered to read “to one of said circumferential clips”.
Regarding claim 5, it is unclear whether the “at least two of said tubes” in lines 1-2 are the same or different “at least two” in claims 1, 3 and 4. As best understood, for purposes of examination, they are the same as in claims 3 and 4, but not necessarily the same two as in claim 1.
Regarding claim 7, line 1 recites “said terminating feature” but claim 1 recites at least two terminating features, such that it is unclear to which claim 7 is referring. As best understood, for purposes of examination, claim 7 will be considered to read “each terminating feature”.
Further regarding claim 7, it is unclear what is meant by “a second dimension corresponding to the first dimension” in line 4. As best understood, for purposes of examination, the dimensions are measurements made across the bottoms of the respective umbrella seals.
Claim 7 recites the limitation "said tube transition feature that is communicatively coupled to said terminating feature" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. As best understood, for purposes of communication, the claim will be considered to read “a base of the associated nasal prong”.
Regarding claims 12 and 13, it is unclear if claim 12 is intended to positively recite the filtration element, given that it is said to be “embedded,” or not, given the “designed[/configured] to house” language, and re: claim 13, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite, see MPEP 2173.05(p).II, and also “the air borne particles” in claim 13 lack antecedent basis. For purposes of examination, claim 12 will be considered to read “ing" claim 13 will be considered to read “wherein said embedded filtration element is configured to filter
Claim 14 recites the limitation "said exhaust port" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, claim 14 will be considered to depend from claim 2, which provides the requisite antecedent basis.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 2, 9, 10 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Amarasinghe (US 2011/0203591 A1; hereinafter “Amarasinghe”).
Regarding claim 1, Amarasinghe discloses a face mask (mask assembly 10) (e.g. Figs. 2-3 and 5-6) comprising:
a mask body (frame 14) including an interior side (to the left in Fig. 3/facing the viewer in Fig. 5) and an exterior side (generally to the right in Fig. 3/facing away from the viewer in Fig. 5), said interior side designed to cover a mouth and a nose of a subject (e.g. Fig. 3);
at least two inlet ports (ports 70) defined on said mask body and designed to provide access between said exterior side and said interior side of said mask body (Figs. 2-3; para [0058]);
at least two tubes (e.g. supplemental hoses 145 OR supplemental hoses+bridging portions 76) (e.g. Fig. 6 in view of Fig. 13C; para [0076]) designed to convey air flow and/or oxygen flow and at least a portion of each of said tubes is disposed on said exterior side of said mask body (e.g. Fig. 6 in view of Fig. 13C; each port…onto which small bore tubing…may be attached, para [0058]);
at least two tube transition features (bridging portions 76 OR comprised by the lower portions of cannulas 45), each of which is communicatively coupled to at least one of said tubes and including a portion that is disposed on said interior side of said mask body and is designed to advance air flow and/or oxygen flow received from said tube communicatively coupled to said tube transition feature (Figs. 5-6; paras [0061-64], [0073-77]);
at least two nasal prongs (cannulas 45 OR the upper portions of cannulas 45) (e.g. Figs. 5 and 7-1 to 7-6; paras [0065], [0069]), each of which is communicatively coupled to at least one of said tube transition features and designed to receive air flow and/or oxygen flow from said tube transition feature and designed to further advance air flow and/or oxygen flow towards or into the nostrils of the subject (paras [0061-65], [0069], [0073-77]);
at least two terminating features (e.g. bead 235 or portion 245) (Figs. 5 and 7-4/5; para [0065]), each of which is disposed around said nasal prongs and designed to occupy or stabilize said nasal prongs within nasal cavity inside the nostril of the subject (Figs. 7-4/5; para [0065]); and
wherein at least two of said tubes (supplemental hoses+bridging portions 76) pass through at least two of said inlet ports such that portions (bridging portions 76) of at least two of said tubes are present on said interior side of said mask body (e.g. Fig. 6 in view of Fig. 13C; paras [0074-76]) or at least two of said tube transition features (when considered as bridging portions 76) pass through at least two of said inlet ports such that portions (bases 73) of at least two of said tube transition features are present on said exterior side of said mask body (Fig. 6; paras [0074-76]).
Regarding claim 2, Amarasinghe discloses the face mask of claim 1, further comprising an exhaust port (vent assembly 42 and/or the central port when not occupied by elbow assembly 18, e.g. as shown in Figs. 5-6) disposed on said mask body at a region that is designed to be near the mouth of said subject (Fig. 3; where the entire mask is near the mouth) and said exhaust port being designed to remove, out of said mask body, exhaled air present inside said interior side (para [0056] and in light of the central port being an unobstructed opening to the exterior in Figs. 3 and 5-6).
Regarding claim 9, Amarasinghe discloses the face mask of claim 1, wherein when at least two of said tubes (supplemental hoses+bridging portions 76) pass through at least two of said inlet ports (70) such that said portions (76) of at least two of said tubes are present on said interior side of said mask body (e.g. Fig. 6 in view of Fig. 13C; paras [0074-76]), then at least two of said tubes are arranged to angularly displace about respective ones of at least two of said inlet ports (e.g. Fig. 6 in view of Fig. 13C; paras [0058], [0074-76]; where a standard, small-bore supplemental gas tube is flexible and thus fully capable of being angularly displaced around an inlet port 70).
Regarding claim 10, Amarasinghe discloses the face mask of claim 1, wherein when at least two of said tube transition features (when considered as bridging portions 76) pass through at least two of said inlet ports (70) such that portions (73) of at least two of said tube transition features [are] present on the exterior side of said mask body (Fig. 6; paras [0074-76]), then at least two of said tube transition features are arranged to angularly displace about respective ones of at least two of said inlet ports (bridging portion 76 may be formed from plastic rubber, para [0073], where rubber is flexible and thus fully capable of being angularly displaced around an inlet port 70).
Regarding claim 15, Amarasinghe discloses the face mask of claim 1, further comprising one or more mounting features (clips 34) of securing thereon retention straps being designed to secure said mask body around the mouth and the nose of the subject (Figs. 1 and 3; para [0056]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Amarasinghe in view of Johnson, Jr. et al. (US 5,438,979; hereinafter “Johnson”).
Regarding claim 3, Amarasinghe discloses the face mask of claim 1, but Amarasinghe is silent regarding a single source tube extending to at least one Y-split that is designed for splitting the air flow and/or the oxygen flow inside said single source tube into at least two of said tubes, and wherein said single source tube is communicatively coupled to a source of air and/or oxygen. However, Johnson teaches that it was well known in the supplemental gas delivery art before the effective filing date of the claimed invention to include a single source tube (dashed line in Fig. 1) extending to at least one Y-split (fitting 17) that is designed for splitting the air flow and/or the oxygen flow inside said single source tube into at least two tubes (tubes 15), and wherein said single source tube is communicatively coupled to a source of air and/or oxygen (col. 2, lines 25-43). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Amarasinghe to include a single source tube extending to at least one Y-split that is designed for splitting the air flow and/or the oxygen flow inside said single source tube into at least two of said tubes, and wherein said single source tube is communicatively coupled to a source of air and/or oxygen as taught by Johnson, in order to provide the predictable result of a standard connection means (y-split) for attaching two supplemental gas delivery tubes to a single gas source for convenience and delivery of the same gas to both tubes.
Claim(s) 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Amarasinghe in view of Johnson as applied to claim 3, and further in view of O’Connor et al. (US 2014/0000626 A1; hereinafter “O’Connor”).
Regarding claims 4 and 5, Amarasinghe in view of Johnson teaches the face mask of claim 3, wherein Johnson further educates modified Amarasinghe to include said face mask further comprising:
a circumferential clip (bow 25 comprising clip 27) disposed around each of said tubes (Johnson Fig. 5), and
an adjustable head strap (strap 40) that couples at one end to said circumferential clip and is designed, at another end, to be disposed behind a head of the subject to stabilize positioning of at least two of said tubes around the head of the subject (Johnson Figs. 4-5), in order to provide the predictable result of a known means (circumferential clips and rear straps) for holding the tubes steady on the patient, but modified Amarasinghe is silent regarding wherein said single source tube and/or at least two of said tubes include smooth-bore tubing to facilitate high-flow oxygen and high-flow air delivery and are made from a corrugated material for facilitating efficient air flow and/or oxygen flow. However, O’Connor teaches that it was known in the respiratory therapy art before the effective filing date of the claimed invention to utilize smooth-bore tubing to facilitate high-flow oxygen and high-flow air delivery made from a corrugated material for facilitating efficient air flow and/or oxygen flow (Fig. 3B; smooth bore to provide low resistance to flow, while the exterior wall layer of the tube is corrugated to aid with body flexibility, para [0481]; high-flow applications, para [0592]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Amarasinghe to include wherein said single source tube and/or at least two of said tubes include smooth-bore tubing to facilitate high-flow oxygen and high-flow air delivery and are made from a corrugated material for facilitating efficient air flow and/or oxygen flow as taught by O’Connor, in order to provide the predictable results of low flow resistance and body flexibility (O’Connor para [0481]).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Amarasinghe in view of Tatkov (US 2012/0305001 A1; hereinafter “Tatkov”).
Regarding claim 6, Amarasinghe discloses the face mask of claim 1, wherein Amarasinghe further discloses a peripheral seal (cushion 16) disposed around a periphery of said mask body (Figs. 1-3; para [0056]), but Amarasinghe is silent regarding wherein said peripheral seal includes a gel or is an inflatable portion designed for snugly fitting said mask body around the mouth and the nose of the subject. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07,Tatkov teaches that it was known in the art of masks with nasal prongs therein before the effective filing date of the claimed invention to include wherein said peripheral seal (seal 311) (Fig. 3) includes a gel (seal…311… encapsulated gel (forming a gel pad), para [0166]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the seal of Amarasinghe to include a gel as taught by Tatkov, in order to utilize a standard cushion material (gel) to form the seal to provide user comfort and functionality with low deformation forces (Tatkov para [0166]).
Claim(s) 7 rejected under 35 U.S.C. 103 as being unpatentable over Amarasinghe in view of Zhan et al. (US 2019/0351170 A1; hereinafter “Zhan”).
Regarding claim 7, Amarasinghe discloses the face mask of claim 1, wherein Amarasinghe teaches that any suitable terminating feature can be used (e.g. Figs. 7-1 to 7-6; para [0065]) but Amarasinghe is silent regarding wherein said terminating feature includes a first umbrella seal and a second umbrella seal, wherein said first umbrella seal includes a first base portion having a first diameter or a first dimension and said second umbrella seal includes a second base portion having a second diameter or a second dimension corresponding to said first dimension, wherein said first base portion is closer in distance than said second base portion to said tube transition feature that is communicatively coupled to said terminating feature, and wherein said first base portion has a greater diameter than the second base portion or said first dimension is larger than corresponding said second dimension. However, Zhan teaches that it was known in the nasal prong terminating feature art before the effective filing date of the claimed invention for a terminating feature to include a first umbrella seal (first [upper] sealing rim 122) and a second umbrella seal (second [lower] sealing rim 122) (Fig. 2; para [0088]), wherein said first umbrella seal includes a first base portion having a first diameter or a first dimension and said second umbrella seal includes a second base portion having a second diameter or a second dimension corresponding to said first dimension (Fig. 2; the radius/dimension of the lower-most part of each umbrella-shaped rim 122), wherein said first base portion is closer in distance than said second base portion to said tube transition feature that is communicatively coupled to said terminating feature (Fig. 2; first sealing rim 122…away from the nasal pad body 11, and a second sealing rim 122 is closer to the nasal pad body when compared with the first sealing rim 122, para [0088]), and wherein said first base portion has a greater diameter than the second base portion or said first dimension is larger than corresponding said second dimension (Fig. 2, where the base of the second/lower sealing rim extends out further/has a larger dimension than the first/upper sealing rim; the projection of the first sealing rim 122 on the second sealing rim 122 covers the second sealing rim 122 [only] partially, para [0088]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Amarasinghe to include wherein said terminating feature includes a first umbrella seal and a second umbrella seal, wherein said first umbrella seal includes a first base portion having a first diameter or a first dimension and said second umbrella seal includes a second base portion having a second diameter or a second dimension corresponding to said first dimension, wherein said first base portion is closer in distance than said second base portion to said tube transition feature that is communicatively coupled to said terminating feature, and wherein said first base portion has a greater diameter than the second base portion or said first dimension is larger than corresponding said second dimension as taught by Zhan, in order to utilize known structure (two tapered umbrella seals) to provide the predictable result of a better sealing effect (Zhan para [0085]), by providing both redundancy of sealing, as well as sizing the seals to correspond to the natural tapering of a typical nostril for user comfort and/or ease of installation and/or for ensuring an effective double seal.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Amarasinghe in view of McAuley et al. (US 9,333,315 B2; hereinafter “McAuley”).
Regarding claim 8, Amarasinghe discloses the face mask of claim 1, wherein Amarasinghe further discloses a bridge feature (device 43 comprising end portion 86) (Fig. 7) having defined therein at least two inlet apertures (holes 90) designed for receiving the air flow and/or the oxygen flow from at least two of said tubes, and structurally integrating at least two of said tube transition features (when considered as comprised by the lower portions of cannulas 45) such that, during an operative state of said bridge feature, the air flow and/or the oxygen flow received from at least two of said tubes is advanced to at least two of said tube transition features (Figs. 4 and 7; para [0079]), but Amarasinghe does not disclose this embodiment in combination with the embodiment comprising the nasal prongs with terminating features. However, McAuley teaches that it was known in the respiratory therapy art before the effective filing date of the claimed invention to provide a single-upper-opening bridge (body part 22) (Fig. 6) in combination with nasal prongs (prongs 24, 25) with terminating features (protrusions 35, 35). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Amarasinghe to combine the bridge and nasal prong embodiments as taught by McAuley to arrive at the claimed invention, in order to allow a user to easily configure the device for single-opening delivery or nasal-prong delivery by inserting the bridge of Amarasinghe Fig. 7 into the mask as shown in Amarasinghe Fig. 4 and then optionally adding nasal prongs as a topper on the bridge, as taught by McAuley, if desired.
Claim(s) 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Amarasinghe in view of Chang (US 2016/0030695 A1; hereinafter “Chang”).
Regarding claim 11, Amarasinghe discloses the face mask of claim 1, but Amarasinghe is silent regarding wherein at least a front portion of said mask body is transparent to allow visibility into said interior side of said mask body and into at least two of said nasal prongs for facilitating adjustment into the nostril of the subject. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Chang teaches that it was known in the art of respiratory masks with nasal prongs therein before the effective filing date of the claimed invention to include wherein at least a front portion of said mask body (mask body 510) is transparent (Fig. 7; mask body 510 material can be transparent, para [0096]) to allow visibility into said interior side of said mask body and into at least two of said nasal prongs (behind ports 570 in Fig. 7) for facilitating adjustment into the nostril of the subject (para [0096]; where the intended use is fully capable given the transparency taught by Chang). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Amarasinghe to include wherein at least a front portion of said mask body is transparent to allow visibility into said interior side of said mask body and into at least two of said nasal prongs for facilitating adjustment into the nostril of the subject as taught by Chang, in order to provide the predictable result of allowing clinicians to observe the patient’s condition (Chang para [0096]).
Regarding claim 12, Amarasinghe discloses the face mask of claim 1, wherein Amarasinghe further discloses one or more secondary airflow ports (vent assembly 42 and/or the central port occupied by elbow assembly 18) (Fig. 1), but Amarasinghe is silent regarding one or more secondary airflow ports, as best understood, housing an embedded filtration element. However, Chang teaches/suggests that it was known in the art of respiratory masks with nasal prongs therein before the effective filing date of the claimed invention to include one or more secondary airflow ports (vent port 230) (Fig. 2) housing an embedded filtration element (filters 260) (Fig. 4; para [0087], where including the filters in the ports would have been an obvious configuration for securing the filters to the ports). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Amarasinghe to include the one or more secondary airflow ports housing an embedded filtration element as taught by Chang, i.e. to include a filter in the openings of the vent assembly 42 and/or the central port occupied by elbow assembly 18 of Amarasinghe, in order to provide the predictable result of filtering the incoming and/or out-going gases to prevent contamination and/or infection of the user and/or the environment (Chang para [0087]).
Claim(s) 13 and 14 rejected under 35 U.S.C. 103 as being unpatentable over Amarasinghe or Amarasinghe in view Chang as applied to, as best understood, claims 2 and 12 above, and further in view of Parazynski et al. (US 11,253,670 B1; hereinafter “Parazynski”).
Regarding claims 13 and 14, Amarasinghe in view of Chang teaches the face mask of claim 12, but modified Amarasinghe is silent regarding wherein said embedded filtration element filters out at least 95% of the air borne particles or further comprising a high-efficiency particulate air (“HEPA”) filter coupled to an exhaust tube, which is connected to said exhaust port. However, it has been held to be within the general skill of one in the art to select a known material on the basis of its suitability for the intended use, see MPEP 2144.07, and Parazynski teaches that it was known in the respiratory therapy art before the effective filing date of the claimed invention to include wherein said embedded filtration element (filter F) (Fig. 1) filters out at least 95% of the air borne particles (col. 9, lines 30-45) or further comprising a high-efficiency particulate air (“HEPA”) filter (e.g. filter 570) coupled to an exhaust tube (body 510), which is connected to said exhaust port (at fitting 535) (Fig. 28; HEPA…N-95…N-99…N-100, col. 9, lines 30-45). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Amarasinghe to include wherein said embedded filtration element filters out at least 95% of the air borne particles or further comprising a high-efficiency particulate air (“HEPA”) filter coupled to an exhaust tube, which is connected to said exhaust port as taught by Parazynski, in order to provide the predictable result of a desired (high) level of particulate filtration (Parazynski col. 9, lines 30-45).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references teaching the integration of nasal prongs inside face masks: Yarahmadi (US 2012/0125338 A1); Hussain (US 2014/0107517 A1); Bahammam (US 2017/0246414 A1); Kertser et al. (US 2018/0207386 A1); Zoellner et al. (US 2021/0016050 A1). Additional references regarding double terminating features for nasal prongs: Thomlinson et al. (US 2005/0011524 A1; Fig. 1, paras [0259-263]); Wondka (US 2005/0066976 A1; Fig. 18D); Tohara (US 2007/0106382 A1); Genger et al. (US 2014/0166021 A9); Lubke et al. (US 9,032,955 B2; Fig. 38). Additional references regarding holding means for nasal cannula tubes: Sullivan (US 4,944,310); Tiep (US 4,422,456); Jackman et al. (US 8,701,669 B2).
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785