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 .
Priority
Priority is acknowledged to PRO 63/056884 according to the Application Data Sheet submitted 05/23/2023, for a priority date of 07/27/2020. It appears that Application data Sheet submitted 05/24/2023 contains an incorrect title for the application.
Information Disclosure Statement
The information disclosure statement (IDS) dated 05/23/2023 has been received and considered.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the locking assembly of the detachable airway tube as described in the specification in [0059]. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Claim 1 limitation “airway tube” has been interpreted to mean a tube which keeps a patient’s airway open. This appears to be a commonly used term in the art and includes a variety of tubes which are inserted into the patient’s airway. This interpretation is supported by figure 11 and [0059] in the instant application.
Claim Objections
Claims 1 and 16 are objected to because the limitation “a second conduit passing from the first conduit” (claim 1, line 5) could be better phrased as “a second conduit in fluid communication with the first conduit” to clarify the structural relationship between the first and second conduit.
Claim 16 also contains a typo in “comprising as second”, which should read “comprising [[as]] a second”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “membrane” in claims 1 and 14 is used by the claim to refer to “a flat, flexible structure” of the mask interface device, while the accepted meaning is “a thin soft pliable sheet or layer” (Merriam-Webster). Based on the specification and drawings, it does not appear that the “membrane” is a thin, soft pliable sheet, but is a rather more substantial structure as seen in figures, since the device includes several structures positioned within the device. Membranes are typically thin enough that they do not support substantial structures within its interior, as shown in the present application’s figures. The term is indefinite because the specification does not clearly redefine the term. It is suggested to amend the term “membrane” to instead be, for example, “a panel”, as depicted in the figures.
Claims 2-13 and 15-20 are rejected as dependent upon claims 1 and 14, respectively.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-3, 8-10, and 13 are rejected under 35 U.S.C. 103 as unpatentable over Eves et al. (US 2021/0038848 A1), hereafter Eves, in view of Northway-Meyer (US 4848331), hereafter Northway-Meyer.
Regarding Claim 1, Eves discloses an airway mask interface apparatus (figs. 13-32), comprising: a membrane (fig. 14, shell 3210, par. 0373; this may be considered a membrane as it is a thin wall structure) including an upper surface (upper surface of shell 3210, fig. 14, par. 0435 line 32; refer to annotated figure below) and a lower surface (lower surface of 3100 and 3230, fig. 13 par. 0449; this may be integral with shell 3210, par. 0372 lines 9-11; refer to annotated figure below), the upper surface adapted to engage an output of an external gas providing mask (upper surface is capable of receiving an external gas providing mask; “adapted to receive” is considered functional limitation, see MPEP 2173.05(g)) and the lower surface adapted to engage a user's face (3100 is arranged to surround entrances of a user’s airways, par. 00358); a first conduit passing through the membrane from the upper surface to the lower surface (fig. 13, 3240 and inner area of 3271 serve as the first conduit; examiner’s note: “conduit” is interpreted according to the dictionary definition “a means of transmitting or distributing”, Merriam-Webster) and located in a position corresponding to a point of contact with a mouth region of the user's face when the membrane is placed on the user's face (fig. 1C, fig. 97, and the position of the nasal holes 3272 aligned with the nares would place the conduit 3240 in alignment with a wearer’s mouth, par. 0363; examiner’s note: this limitation is interpreted such that direct contact is not necessarily required between the first conduit and the user’s mouth region); and a second conduit (fig. 13, nasal hole 3272, par. 0363) passing from the first conduit (nasal hole 3272 is open to the first conduit 3240 as seen in cutaway fig. 17) to a point of contact with a nose region of the user's face when the membrane is placed on the user's face (par. 0363 lines 11-13).
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However, Eves is silent on an airway tube in fluid communication with the first conduit, wherein the airway tube is attached to the first conduit at the lower surface of the membrane.
Northway-Meyer teaches the use of an airway tube in fluid communication with a first conduit (fig. 2, airway tube 271 (not labeled but shown in this fig.), face mask 330, airway receiving channel 341, col. 22 lines 61-65) wherein the airway tube is attached to the first conduit at the lower surface of the membrane (fig. 37, receiving channel 340 extends through the mask body to the lower surface).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an airway tube in fluid communication with Eves’ first conduit, wherein the airway tube is attached to the first conduit at the lower surface, as taught by Northway-Meyer, in order to be able to ventilate a patient concurrently with performing an endotracheal intubation through the oral airway (Northway-Meyer col. 4 lines 34-40).
Regarding Claim 2, Eves discloses an airway mask interface apparatus of claim 1; however, Eves does not disclose if there is an inflatable chamber configured with the membrane between the upper surface and lower surface of the embodiment of figure 13.
However, Eves does disclose an embodiment of the airway mask interface which further comprising at least one inflatable chamber configured with the membrane between the upper surface and the lower surface (Fig. 3L, par. 0152 and fig. 110, 111, seal forming structure 3100 par. 0413). This inflatable chamber is “advantageous in creating a good seal to the complex geometry under and around the nose” (par. 0413).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Eves’ fig. 13 embodiment to include at least one inflatable chamber configured between the upper surface and the lower surface, as Eves indicates that inflatable chambers are a known face sealing structure, as well as it improves the seal around the patient’s nose and mouth geometry, which varies between patients.
Regarding Claim 3, Eves discloses an airway mask interface apparatus of claim 2, but is silent on wherein the at least one inflatable chamber includes a valve mechanism adapted to inflate and/or deflate the at least one inflatable chamber.
Northway-Meyer teaches the use of a valve to inflate the pneumatic cushion of the oral mask (fig. 22, mask 230 having cushion 232 with valve 238, col. 18 lines 10-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a valve with Eves’ inflatable chamber in order to vary the pressure of the cushion by varying the amount of gas used to inflate the cushion through the use of the valve, as taught by Northway-Meyer, for the benefit of a better seal of the mask with the face and to improve the comfort of the patient (col. 18 lines 18-27).
Regarding Claim 8, Eves discloses an airway mask interface apparatus of claim 1 wherein the membrane includes a first portion located in a position corresponding to a point of contact with a chin region of the user's face when the membrane is placed on the user's face ([0463] line 2, lip inferior portion 3118 may form a seal on the user’s chin; fig. 16), a second portion located in a position corresponding to a point of contact with a mouth and cheek region of the user's face when the membrane is placed on the user's face (fig. 13, mouth region at oral portion 3260 contacts the mouth, [0461] line 3, and the cheek, par. 0464 line 13), and/or a third portion located in a position corresponding to a point of contact with a nose region of the user's face when the membrane is placed on the user's face (fig. 13, nasal portion 3230, [0465] line 11).
Regarding Claim 9, Eves discloses an airway mask interface apparatus of claim 1, but is silent on whether the embodiment of fig. 13’s second conduit includes a first tube adapted to be received into a first nostril of the user, and a second tube adapted to be received into a second nostril of the user.
Eves’ second conduit has two tubes (best seen in fig. 20), but these cannot be received into the user’s nostrils. Eves does, however, teach an embodiment of an airway mask interface which includes a first tube adapted be received into a first nostril of a user (fig. 3G, the first tube may be the left nasal pillow, par. 0147) and a second tube adapted to be received into a second nostril of a user (fig. 3 G, the second tube may be the right nasal pillow, par. 0147). Eves teaches that this is an alternative nasal sealing structure which improves flexibility to the fitment of the individual nasal structure of the wearer, since the stalk of the nasal pillow flexes to provide a better fit to the user’s nares (par. 0471-0472).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second conduit of Eves’ invention by adding the first and second tubes as Eves discloses as an alternative embodiment in order to improve fitment and comfort by increasing flexibility in the fitment to the user’s nostrils.
Regarding Claim 10, Eves discloses an airway mask interface apparatus of claim 1 wherein the second conduit is substantially perpendicular to the first conduit (figs 13 and 14, second conduit 3272 appears to be substantially perpendicular to the opening direction of the first conduit 3240; examiner’s note: “substantially” is interpreted according to its definition ”for the most part, essentially”, Oxford Languages dictionary).
Regarding Claim 13, Eves discloses an airway mask interface apparatus of claim 1, wherein the airway tube is detachably attached to the first conduit at the lower surface of the membrane (as modified by Northway-Meyer, the airway tube is attached to the first conduit at the lower surface of the membrane, fig. 37; the mask is removed from the ET tube after intubation is performed, col. 26, lines 31-35; thus the airway tube is detachably attached).
Claim 11 is rejected under 35 U.S.C. 103 as unpatentable over Eves and Northway-Meyer, further in view of Hendricks et al (US 2015/0013682 A1), hereafter Hendricks.
Regarding Claim 11, Eves discloses an airway mask interface apparatus of claim 1, but is silent on further comprising at least one fringe element configured with the lower surface.
Hendricks teaches a patient airway interface which includes a fringe element on the patient contacting surface (that is, the lower surface) in fig. 3C. Hendricks teaches that this engineered surface texture is advantageous because it will reduce surface area contact with the patient’s skin to reduce red marks and improve skin shear, which can result in pressure injury (par. 0031).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lower surface of Eves’ disclosure with the fringe element as taught by Hendricks in order to improve skin shear to avoid pressure injuries in the wearer.
Allowable Subject Matter
Claims 4-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, as well as rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding Claim 4, Eves discloses an airway mask interface apparatus of claim 1 but is silent on whether the device is further comprising at least one gas containing cassette configured with the membrane and in fluid communication with the first conduit and/or the second conduit.
The closest prior art of record, Schatz (US 11273274 B1), discloses a gas containing cassette which is in fluid communication with a first conduit (fig. 1, 3, cassette is removable cartridge 252, col. 3 line 53; cartridge is in fluid communication with the nasal opening 190, which can be construed as a first conduit, col. 3 line 3, fig. 4 for delivery of vaporized contents to the user).
However, there is no suggestion or teaching which would indicate to one of ordinary skill in the art to combine the inventions of Eves and Schatz into a single device. The face masks are structurally dissimilar with different functions and no motivation is provided by either disclosure to combine the two face masks.
Another prior art of record, Engelder (US 2641253) discloses a gas containing cassette (figs. 1 and 2, oxygen container 14, mask 12, col. 3 lines 20-24); however, there does not appear to be any motivation to include an oxygen-containing cassette into Eves’ mask since supplemental oxygen is already supplied to the patient through the patient interface (Evers [0537]).
A third prior art of record, DE 10 2017 009 391 A1 appears to feature a gas cassette (13, fig. 4) contained within an airway mask interface. However, the disclosure figures and translation are not clear on the location of the cassette and whether this cassette is in fluid communication with a structure resembling a first and/or second conduit.
Claims 5-7, as dependents upon Claim 4, would also be allowed if the dependency on a rejected base claim (parent claim 1) is resolved.
Claims 14-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Regarding Claim 14, the closest prior art includes Schatz (US 11273274 B1), which discloses an airway mask interface apparatus, comprising: a membrane (mask 100, fig. 1, col. 4 line 20) including an upper surface (upper surface of mask 100 is the outward facing surface, fig. 1) and a lower surface (lower surface is surface inwardly facing patient), the upper surface adapted to engage an output of an external gas providing mask (the mask 100 is capable of engaging with an external gas-providing mask, since it is air permeable, col. 4 line 67) and the lower surface adapted to engage a user's face (fig. 1, the lower surface is shown engaging with the user’s face); and at least one gas cassette in fluid communication with the first conduit (cartridge is in fluid communication with the nasal opening 190, which can be considered a first conduit, col. 3 line 3, fig. 4 for delivery of vaporized contents to the user).
Schatz is silent on a first conduit passing through the membrane from the upper surface to the lower surface and located in a position corresponding to a point of contact with a mouth region of the user's face when the membrane is placed on the user's face, as well at least one gas cassette configured with the membrane at least partially between the upper surface and the lower surface, and an airway tube in fluid communication with the first conduit, wherein the airway tube is attached to the first conduit at the lower surface of the membrane.
Eves discloses an airway mask interface (fig. 13) which has a first conduit (examiner’s note: “conduit” is interpreted according to the dictionary definition “a means of transmitting or distributing”, Merriam-Webster) passing through the membrane from the upper surface to the lower surface (fig. 13, 3240) and located in a position corresponding to a point of contact with a mouth region of the user's face when the membrane is placed on the user's face (fig. 1C, fig. 97, and the position of the nasal holes 3272 aligned with the nares would place the conduit 3240 in alignment with a wearer’s mouth, par. 0363).
However, there is no teaching or known motivation for one of ordinary skill in the art to combine the inventions of Schatz and Eves.
Additionally, there is no prior art of record which discloses at least one gas cassette configured to be located between the upper surface and lower surface of a membrane of an airway mask interface. The closest prior art of record is DE 10 2017 009 391 A1; however, the figures and translated disclosure do not clearly show that the device shown acts as a gas cassette (13, fig. 4).
Claims 15-20 would also be allowed as dependent upon Claim 14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2018/0043121 discloses an airway mask interface (figs. 3A and 3B).
Related patent US 12290634 discloses an airway mask interface
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA K. TOICH whose telephone number is (703)756-1450. The examiner can normally be reached M-Th 7:30 am - 4:30 pm, every other F 7:30-3:30 ET.
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/SARA K TOICH/ Examiner, Art Unit 3785
/BRANDY S LEE/ Supervisory Patent Examiner, Art Unit 3785