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 .
Response to Amendment
This office action is in response to the preliminary amendment filed 8/28/2023. As directed by the amendment, claims 3, 5-11, 13, 16-18, 20-22 and 24 have been amended, and claims 25-57 have been cancelled. As such, claims 1-24 are pending in the instant application.
Election/Restrictions
This application contains claims directed to the following patentably distinct species of slit HMX material:
Species A: Figs. 11A-12B
Species B: Figs. 13A-C and 15A-B
Species C: Figs. 14A-C
The species are independent or distinct because they require different slit arrangements and/or different conformational changes to effect the non-flat shape. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 1-6, 9-16 and 18-24 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
a. the species require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
b. the prior art applicable to one species may not be applicable to another species.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Corey Hawse on 3/9/2026 a provisional election was made without traverse to prosecute the invention of Species A, claims 1-7 and 9-24. Affirmation of this election must be made by applicant in replying to this Office action. Claim 8 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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: SLITTED AND NON-FLAT HEAT AND MOISTURE EXCHANGER DEVICE FOR A PATIENT INTERFACE .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, all of the slits being the same length or each slit having edges that terminate at two common points (i.e. none of the slits are truncated/extend to the edge of the material, as shown in e.g. Figs. 11A/12A, 13A and 14A-B, because these slits are shorter than other slits and have edges that only terminate at a single common point, i.e. the point within the perimeter of the material) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Applicant could address these objections by amending claim 7 to read “wherein all of the slits of the plurality of slits” (because the partial slits in the Figs. could be considered as not part of the claimed plurality) and claim 17 to read “wherein the at least one slit”.
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 Objections
Claims 4 and 18 are objected to because of the following informalities:
Claim 4, line 1 should read “wherein the slits of the plurality of slits are parallel to one another” because “a/the plurality of slits” is a) singular, i.e. the “are” verb does not grammatically match the number of the noun, and b) a single entity cannot be parallel to “one another”
Claim 18, line 4 should read “plenum chamber comprising a connection port”
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 6 and 18-24 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.
Claim 6 recites the limitation "the rows of slits" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, claim 6 will be considered to depend from claim 5, which provides the requisite antecedent basis.
Regarding claim 18 (and thus its dependent claims 19-24), line 19 requires the patient interface to be “configured to leave the patient’s mouth uncovered,” but then lines 19-20 go on to recite “or if the seal-forming structure is configured to seal around the patient’s…mouth” (emphasis added), which conflicts with the mouth being uncovered. For purposes of examination, the claim will be considered to read “uncovered and the patient interface is configured”.
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, 3, 4, 7, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Umehara et al. (US 9,950,133 B2; hereinafter “Umehara”).
Regarding claim 1, Umehara discloses a heat and moisture exchanger (HMX) device (heat and moisture exchanger 9) (Fig. 3) for use with a patient interface system to treat a patient with a flow of air at a therapeutic pressure (col. 1, lines 5-20; col. 2, lines 52-60), the HMX device comprising:
a frame (comprising casing member 7) (Fig. 3); and
at least one layer of HMX material (heat and moisture exchange material 5) supported by the frame (Fig. 3), the HMX material being configured to adsorb water vapour from gases exhaled by the patient and desorb water vapour into the flow of air at the therapeutic pressure (col. 4, lines 1-12; col. 5, lines 6-59), the HMX material being flexible (Figs. 1-2; where the material is flexible enough to be rolled), the at least one layer of HMX material having a flat shape in an undeformed state (Fig. 1), and the at least one layer of HMX material having at least one slit (slits 2) that is configured to be widened when the at least one layer of HMX material is deformed into a non-flat shape (Fig. 2; where the slits are positioned on the outer surface, such that, when coiled, they will widen slightly on the open ends thereof as the inner surface is contracted/the outer surface expanded to form the curvature/spiral).
Regarding claim 3, Umehara discloses the HMX device of claim 1, wherein the at least one slit comprises a plurality of slits (slits 2) (Figs. 1-2).
Regarding claim 4, Umehara discloses the HMX device of claim 3, wherein the plurality of slits are parallel to one another (Fig. 1C).
Regarding claim 7, Umehara discloses the HMX device of one of claim 3, wherein all of the slits are the same length (Fig. 1C).
Regarding claim 13, Umehara discloses the HMX device of claim1, wherein the non-flat shape is curved (Fig. 2; the non-flat shape is a curved roll/spiral).
Regarding claim 15, Umehara discloses the HMX device of claim 13, wherein the non-flat shape has a radius of curvature that is different at different points on the non-flat shape (Fig. 2; where the radius of curvature gets smaller as the spiral/curve moves toward the center).
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) 1-7, 9, 10, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nudeshima et al. (EP 0205072; hereinafter “Nudeshima”) in view of Calisch et al. (US 2017/0182723 A1; hereinafter “Calisch”).
Regarding claim 1, Nudeshima discloses a heat and moisture exchanger (HMX) device (heat and moisture exchanger 1) (Fig. 1) for use with a patient interface system to treat a patient with a flow of air at a therapeutic pressure (Fig. 4), the HMX device comprising:
a frame (housing 2); and
at least one layer of HMX material (sheet 51) supported by the frame (Figs. 1 and 3), the HMX material being configured to adsorb water vapour from gases exhaled by the patient and desorb water vapour into the flow of air at the therapeutic pressure (page 2, lines 2-33), the HMX material being flexible (paper sheets are flexible, see e.g. sheet 51 flexed into corrugations in Fig. 3), the at least one layer of HMX material having a flat shape in an undeformed state (sheet 51 has a flat shape when not corrugated), and the at least one layer of HMX material deformed into a non-flat shape (when sheet 51 is corrugated, see Fig. 3).
While Nudeshima teaches that the heat and moisture exchanger is configured to have a honeycomb-like structure (Fig. 2; page 5, lines 7-11), Nudeshima is silent regarding the at least one layer of HMX material having at least one slit that is configured to be widened when the at least one layer of HMX material is deformed into a non-flat shape. However, Calisch teaches that it was known in the art of honeycomb structure formation/to solve the problem of forming a honeycomb structure before the effective filing date of the claimed invention by utilizing at least one layer of flexible material having a flat shape in an undeformed state (Fig. 1A) and having at least one slit (cut lines 105) that is configured to be widened when the at least one layer of material is deformed into a non-flat shape (Figs. 1C-D). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the formation of the honeycomb HMX structure of Nudeshima to include the at least one layer of HMX material having at least one slit that is configured to be widened when the at least one layer of HMX material is deformed into a non-flat shape as taught by Calisch, in order to use a known method (slitting and folding per Calisch Figs. 1A-D) to provide a honeycomb HMX structure as taught by Nudeshima with minimal waste (Calisch para [0005]) and without bonding (used to secure the corrugations per Nudeshima page 4, lines 30-31), in order to predictably reduce material costs and/or avoid failure points (detached bond regions) and/or minimize the number of materials (if bonding using adhesive) fluidly connected to a patient’s airways that could be a source of irritation.
Regarding claim 2, Nudeshima in view of Calisch teaches the HMX device of claim 1, wherein Calisch educates modified Nudeshima to include wherein the at least one slit passes completely through the at least one layer of HMX material (Calisch Figs. 1A-D), in order to provide the construction discussed above regarding claim 1.
Regarding claim 3, Nudeshima in view of Calisch teaches the HMX device of claim 1, wherein Calisch educates modified Nudeshima to include wherein the at least one slit comprises a plurality of slits (Calisch Fig. 1A), in order to provide the construction discussed above regarding claim 1.
Regarding claim 4, Nudeshima in view of Calisch teaches the HMX device of claim 3, wherein Calisch educates modified Nudeshima to include wherein the plurality of slits are parallel to one another (Calisch Fig. 1A), in order to provide the construction discussed above regarding claim 1.
Regarding claim 5, Nudeshima in view of Calisch teaches the HMX device of claim 3, wherein Calisch educates modified Nudeshima to include wherein the plurality of slits are formed in rows such that all of the slits in each row have a common longitudinal axis (Calisch Fig. 1A), in order to provide the construction discussed above regarding claim 1.
Regarding claim 6, Nudeshima in view of Calisch teaches the HMX device of claim [5], wherein Calisch educates modified Nudeshima to include wherein each of the rows of slits are staggered such that an end of one of the slits in a first row is positioned between ends of one of the slits in a second row that is adjacent to the first row (Calisch Fig. 1A), in order to provide the construction discussed above regarding claim 1.
Regarding claim 7, Nudeshima in view of Calisch teaches the HMX device of claim 3, wherein Calisch educates modified Nudeshima to include wherein all of the slits [of the plurality of slits] are the same length (Calisch Fig. 1A), in order to provide the construction discussed above regarding claim 1.
Regarding claim 9, Nudeshima in view of Calisch teaches the HMX device of claim 1, wherein Nudeshima further discloses wherein the HMX material is fabric, foam, or paper (page 6, lines 10-16).
Regarding claim 10, Nudeshima in view of Calisch teaches the HMX device of claim 1, wherein Nudeshima further discloses wherein the HMX material is treated with a salt compound (page 6, line 17-page 7, line 2).
Regarding claim 16, Nudeshima in view of Calisch teaches the HMX device of claim1, wherein Calisch educates modified Nudeshima to include wherein each slit forms a two-dimensional hole through the at least one layer of HMX material (Calisch Figs. 1A-D), in order to provide the construction discussed above regarding claim 1.
Regarding claim 17, Nudeshima in view of Calisch teaches the HMX device of claim1, wherein Calisch educates modified Nudeshima to include wherein each slit comprises two straight edges that are opposite one another across the slit, each of the edges having a first end that terminates at a first common point, and each of the edges having a second end that terminates at a second common point (Calisch Fig. 1A), in order to provide the construction discussed above regarding claim 1.
Claim(s) 11, 12 and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Nudeshima in view of Calisch as applied to claim 1 above, and further in view of Harrington (US 2016/0175552 A1; hereinafter “Harrington”).
Regarding claim 11, Nudeshima in view of Calisch teaches the HMX device of claim 1, but modified Nudeshima is silent regarding at least two layers of HMX material. However, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, see MPEP 2144.04.VI.B, and Harrington teaches that it was known in the respiratory HMX art before the effective filing date of the claimed invention to include at least two layers of HMX material (Harrington Fig. 7C; para [0430]; where honeycomb layers are stacked horizontally). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Nudeshima to include at least two layers of HMX material as taught by Harrington, in order to provide the predictable result of increasing the device size/surface area available for heat and moisture exchange and/or to allow the shape of the HMX device to be tailored as desired (Harrington paras [0075] and [0430]).
Regarding claim 12, Nudeshima in view of Calisch teaches the HMX device of claim 11, wherein modified Nudeshima further teaches wherein each of the layers of HMX material is the same HMX material or a different HMX material, because these are the two finite possibilities and it must be one of them. Moreover, it would have been obvious to an artisan before the effective filing date of the claimed invention for the layers to be the same material in order to predictably provide more of the same type of exchange and/or to use the same material for economies of scale, or to be different materials in order to predictably provide a different degree and/or type of exchange.
Regarding claim 18, Nudeshima in view of Calisch teaches the HMX device of claim 1 (see discussion above), but modified Nudeshima is silent regarding the device being comprised by a patient interface as instantly claimed. However, Harrington teaches that it was known in the respiratory HMX device art before the effective filing date of the claimed invention to include a HMX device (HME 7000) with a frame (frame 7003) and HMX honeycomb-like material (formed by layers 7001) (Figs. 9A and 9J) in a patient interface comprising:
a plenum chamber (plenum chamber 3200) pressurisable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure by a flow of air at the therapeutic pressure for breathing by a patient (paras [0026], [0232], [0370], [0422], [0456], claim 89), the plenum chamber [comprising] a connection port (mask inlet 3260) configured to receive the flow of air at the therapeutic pressure (Fig. 9A or 15A; paras [0434-435]);
a seal-forming structure (seal-forming structure 3100) connected to the plenum chamber (Fig. 9J or 15A), the seal-forming structure being constructed and arranged to seal with a region of the patient's face at least partly surrounding an entrance to the patient's airways (paras [0026], [0034], [0190-198], [0433]), said seal-forming structure having a hole therein (e.g. Fig. 8B; to the right in Fig. 9J or to the left in Fig. 15A) such that the flow of air at said therapeutic pressure is delivered to at least the patient's nares (paras [0026], [0034], [0072], [0185]), the seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (paras [0321-325], claim 89);
a positioning and stabilising structure (mask frame 3250 and/or positioning and stabilizing structure 3300) comprising at least one tie (elongated member on either side of frame 3250 or strap connectors 3301) configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head (Fig. 9A or 14F in view of Fig. 3A; paras [0037], [0433], [0567-568], claim 89);
a vent structure (vent 3400) configured to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use (Fig. 9A or 15B; paras [0204-206], [0434-435], [0453]); and
wherein the patient interface is configured to leave the patient's mouth uncovered (Figs. 1B and 9A; paras [0026], [0034], [0049], [0190-197], [0433]), or, as best understood, the seal-forming structure is configured to seal around the patient's nose and mouth [and] the patient interface is configured to allow the patient to breath from ambient in the absence of a flow of pressurised air (e.g. Fig. 14D and 15A; paras [0034], [0190-198], [0214], [0433], where Figs. 14D and 15A would have reasonably suggested a standard anti-asphyxia valve on the depicted elbow and/or the vent 3400 also provides the claimed functionality). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to include an HMX device with a frame and HMX honeycomb-like material as taught by modified Nudeshima in a patient interface as claimed and as taught by Harrington, in order to utilize a known/obvious HMX construction in a known patient interface arrangement to provide the predictable result of a patient interface containing an efficiently-constructed HMX device (see claim 1 discussion above) for use in treating disordered breathing (Harrington abstract, paras [0009-20], [0064-65], [0072]).
Regarding claim 19, Nudeshima in view of Calisch and Harrington teaches the patient interface of claim 18, wherein Harrington educates modified Nudeshima to include wherein the HMX device is positioned within the plenum chamber (Harrington Fig. 9J or 15A), in order to provide the HMX functionality in the interface discussed above regarding claim 18.
Regarding claim 20, Nudeshima in view of Calisch and Harrington teaches the patient interface of claim 18, wherein Harrington educates modified Nudeshima to include wherein the HMX device is connected to the plenum chamber (Harrington Fig. 9J or 15A), in order to provide the HMX functionality in the interface discussed above regarding claim 18.
Regarding claim 21, Nudeshima in view of Calisch and Harrington teaches the patient interface of claim 18, wherein Harrington educates modified Nudeshima to include wherein the HMX device is removably connected to the plenum chamber (Harrington Fig. 9A; paras [0080], [0434]), in order to optionally and/or replaceably provide the HMX functionality in the interface discussed above regarding claim 18.
Regarding claim 22, Nudeshima in view of Calisch and Harrington teaches the patient interface of claim 18, wherein Harrington further educates modified Nudeshima to include a connector (swivel 3510) removably and rotatably connected to the connection port (3260) and having a swivel configured to be removably connected to an air delivery tube to receive the flow of air (Harrington Fig. 9A; paras [0208] and [0575]), and Harrington further demonstrates that a connector that is specifically an elbow (e.g. Fig. 14F) was well known in the respiratory patient interface art before the effective filing date of the claimed invention, such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Nudeshima to include an elbow removably and rotatably connected to the connection port and having a swivel configured to be removably connected to an air delivery tube to receive the flow of air as further taught by Harrington, in order to provide the predictable result of a downward-facing swivel connector for patient comfort/reduced line-of-sight of the connecting tubing with a swivel connection between the mask and the connector and the connector and the tube for maximal accommodation of patient movement/decoupling (Harrington paras [0208], [0575]).
Regarding claim 23, Nudeshima in view of Calisch and Harrington teaches the patient interface of claim 22, wherein it has been held that rearranging parts of an invention involves only routine skill in the art, see MPEP 2144.04.VI.C, and Harrington further educates modified Nudeshima to include wherein the elbow further comprises the vent structure (the vent 3400 is located in the plenum chamber…[a]lternatively, the vent 3400 is located in a decoupling structure 3500, e.g. a swivel 3510, Harrington para [0206]), in order to provide the predictable result of locating the vent structure in a location known to be suitable therefor.
Claim(s) 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nudeshima in view of Calisch as applied to claim 1 above, and further in view of Wong et al. (WO 2020/240495 A1; hereinafter “Wong”).
Regarding claim 13, Nudeshima in view of Calisch teaches the HMX device of claim1, wherein Calisch further teaches wherein the non-flat shape is curved (e.g. Fig. 2D, 5B or 26), and Wong teaches that it was known in the respiratory HMX art before the effective filing date of the claimed invention to utilize an HMX with a shape wherein the shape is curved (Figs. 23 and 32; paras [0244-246]), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Nudeshima to include wherein the non-flat shape is curved as taught by Calisch and Wong, in order to provide the predictable result of an HMX device that is shaped to fit into a known (curved) patient interface to provide an efficiently-constructed HMX device (see claim 1 discussion above) for use in treating disordered breathing (Wong paras [0244-246]).
Regarding claim 14, Nudeshima in view of Calisch teaches the HMX device of claim 13, wherein Wong further educates modified Nudeshima to include wherein the non-flat shape has a uniform radius of curvature (Wong Fig. 23), in order to predictably fit the HMX device to a patient interface with a uniform radius of curvature.
Regarding claim 15, Nudeshima in view of Calisch teaches the HMX device of claim 13, wherein Calisch and Wong further educate modified Nudeshima to include wherein the non-flat shape has a radius of curvature that is different at different points on the non-flat shape (Calisch Fig. 2D or 26; Wong paras [0234] and [0241], when varying the thickness), in order to predictably fit the HMX device to a patient interface with a radius of curvature that is different at different points.
Claim(s) 18 and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Nudeshima in view of Calisch as applied to claim 1 above, and further in view of Hallett et al. (US 2013/0186394 A1; hereinafter “Hallett”).
Regarding claim 18, Nudeshima in view of Calisch teaches the HMX device of claim 1 (see discussion above), but modified Nudeshima is silent regarding the device being comprised by a patient interface as instantly claimed. However, Hallett teaches that it was known in the respiratory HMX device art before the effective filing date of the claimed invention to include a HMX device (heat and moisture exchange element 61) with a frame (housing 63) and HMX material (HME insert 69) (Fig. 4; para [0076]) in a patient interface comprising:
a plenum chamber (within interface 12) (see Fig. 3) pressurisable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure by a flow of air at the therapeutic pressure for breathing by a patient (para [0004]; obvious for the mask of Hallet to meet the typical minimum operating pressure for CPAP in order to be used as CPAP mask), the plenum chamber [comprising] a connection port (opening to the left in Fig. 3) configured to receive the flow of air at the therapeutic pressure (para [0004]);
a seal-forming structure connected to the plenum chamber (obvious to be present to form the sealed connection of para [0064]), the seal-forming structure being constructed and arranged to seal with a region of the patient's face at least partly surrounding an entrance to the patient's airways (Fig. 1; para [0064]), said seal-forming structure having a hole therein (the opening for the face that is required for mask seals) such that the flow of air at said therapeutic pressure is delivered to at least the patient's nares (Fig. 1; paras [0064-65]), the seal-forming structure being constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (paras [0004], [0064]l obvious in order to ensure that the desired CPAP pressure is delivered);
a positioning and stabilising structure (e.g. comprising the straps of Fig. 1) comprising at least one tie (headgear straps and/or the frame connectors in Fig. 3) configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head (para [0004], per the standard function of CPAP mask headgear);
a vent structure (comprising exhausted apertures 30) configured to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use (Fig. 7; paras [0069], [0079-86], where a continuous flow occurs during exhalation) and
wherein the patient interface is configured to leave the patient's mouth uncovered (Figs. 1-2; a nasal user interface is depicted here, para [0065]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to include an HMX device with a frame and HMX material as taught by modified Nudeshima in a patient interface as claimed and as taught by Hallett, in order to utilize a known/obvious HMX construction in a known patient interface arrangement to provide the predictable result of a patient interface containing an efficiently-constructed HMX device (see claim 1 discussion above) for use in treating disordered breathing (e.g. Hallett paras [0004-5]).
Regarding claim 20, Nudeshima in view of Calisch and Hallett teaches the patient interface of claim 18, wherein Hallett educates modified Nudeshima to include wherein the HMX device is connected to the plenum chamber (Hallett Figs. 3-4), in order to provide the HMX functionality in the interface discussed above regarding claim 18.
Regarding claim 21, Nudeshima in view of Calisch and Hallett teaches the patient interface of claim 18, wherein Hallett educates modified Nudeshima to include wherein the HMX device is removably connected to the plenum chamber (Hallett Figs. 3-4; para [0076]), in order to optionally and/or replaceably provide the HMX functionality in the interface discussed above regarding claim 18.
Regarding claim 22, Nudeshima in view of Calisch and Hallett teaches the patient interface of claim 18, wherein Hallett further educates modified Nudeshima to include an elbow (apparatus 10) removably and rotatably connected to the connection port and having a swivel (swivel connector 76) configured to be removably connected to an air delivery tube to receive the flow of air (Figs. 1-4; paras [0009], [0067-70]), because it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Nudeshima to include an elbow removably and rotatably connected to the connection port and having a swivel configured to be removably connected to an air delivery tube to receive the flow of air as further taught by Hallett, in order to provide the predictable result of a downward-facing connector for patient comfort/reduced line-of-sight of the connecting tubing with a swivel connection between the mask and the connector and the connector and the tube for maximal accommodation of patient movement/decoupling (Hallett para [0070]).
Regarding claim 23, Nudeshima in view of Calisch and Hallett teaches the patient interface of claim 22, wherein Hallett educates modified Nudeshima to include wherein the elbow further comprises the vent structure (Hallett Fig. 4), in order to utilize the vent structure/elbow discussed above regarding claims 18 and 22.
Regarding claim 24, Nudeshima in view of Calisch and Harrington teaches the patient interface of claim 22, wherein Hallett educates modified Nudeshima to include wherein the HMX device is positioned within the elbow (Hallett Fig. 4), in order to provide the HMX functionality near the interface as discussed above regarding claim 18.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Additional references teaching forming a 3D honeycomb structure by slitting a flat layer of material and deforming it to widen the slits: Delage et al. (US 5,415,715); Herrera et al. (US 10,443,496 B2); Norcom et al. (US 5,894,044); North (US 2006/0163756 A1). Additional references regarding honeycomb-like celled HMXs for respiratory interfaces: Dodd, Jr. (US 5,595,173); Gutpa et al. (US 2022/0054783 A1; Fig. 139); Haycock (EP 0255387); Holecek et al. (WO 2006/017875 A1); Nilson (US 5,906,201); Numano (US 5,007,114); Wang et al. (US 2024/0189533 A1). Additional references teaching HMX materials in/associated with respiratory elbows: Lambert et al. (US 5,462,048); Thomas (US 2011/0108036 A1). Additional reference teaching HMX materials of different shapes/thicknesses/curvatures: Harrison (US 2016/0158474 A1; para [0047]); Short (WO 2022/073075 A1; para [0288]).
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/KATHRYN E DITMER/ Primary Examiner, Art Unit 3785
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