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 amendment filed 09/07/23. Claim(s) 18, 20, 23, 25, 27-28, 31, 33, 35, and 37-42 have been amended, no new claims have been added, and claims 1-15 and 43-69 have been cancelled. Thus, claims 16-42 are presently pending in this application.
Claim Objections
Claim 16 is objected to because of the following informalities: In claim 16, lines 11-12 "the patient's face" is suggested to be changed to --a patient's face-- to correct antecedent basis. Appropriate correction is required.
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) 16-19, 31-32, 35-39, and 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ng (2010/0319700).
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Annotated fig 2 of Ng.
Annotated fig 6 of Ng.
With respect to claim 16, Ng discloses a patient interface (1010, fig 1) comprising a plenum chamber (1040 defines a chamber; see [0097] and fig 4) being formed entirely from a flexible material (resilient material; see [0099]), the plenum chamber including a cavity (chamber formed by 1040; see [0097]) that is pressurisable to a therapeutic pressure (see [0003]) of at least 6 cmH20 above ambient air pressure (2-30 cmH20; [0003]), an inlet port (1046, fig 2) configured to provide fluid communication between the cavity and ambient (see [0097]), and a groove (see annotated fig 2 of Ng; note the groove is formed on both side of the plenum) formed on a surface of the plenum chamber outside the cavity and exposed to ambient pressure, the groove formed radially outside of the inlet port, and the groove forming an enclosed perimeter; a seal-forming structure (1060, fig 4) constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways (see fig 1B and [0141]), the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the cavity of the plenum chamber throughout the patient's respiratory cycle in use (see [0092]); a positioning and stabilizing structure (1020/1032/1021/1024/1025, fig 4) configured to maintain the seal-forming structure in a therapeutically effective position (see [0111 and 124]), the positioning and stabilizing structure comprising a frame (1020, fig 4) coupled to the plenum chamber (removably coupled; see fig 4 and [0124]), the frame including, a central portion (see annotated fig 6 of Ng) including an inner perimeter (see annotated fig 6 of Ng) and an outer perimeter (see annotated fig 6 of Ng), the inner perimeter and the outer perimeter being removably positionable within the groove (see [0097]), the inner perimeter configured to be spaced apart from the inlet port while positioned within the groove (see fig 3 where the inner perimeter is not in close contact with the port), a pair of upper arms (1024, fig 6) that extends away from the central portion in a posterior direction (see fig 6 where 1024 extend from the central part), the pair of upper arms being configured to, in use, extend over the patient's cheeks (see fig 1B and [0102]), and a pair of lower arms (1025, fig 6) that extends away from the central portion (see fig 6); and headgear straps (1090; fig 1B) coupled to the pair of upper arms and the pair of lower arms of the frame (see fig 1B and [0125]), and configured to provide a tensile force to the seal-forming structure into the patient's face via the frame (see fig 1B and [0124-125]).
With respect to claim 17, Ng discloses the pair of upper arms are longer than the pair of lower arms (see figs 3 and 6).
With respect to claim 18, Ng discloses the pair of upper arms each include a first type of connector (slot; 1027, fig 6) and the pair of lower arms each include a second type of connector (clip; 1031, fig 6) that is different from the first type of connector (see difference in fig 6).
With respect to claim 19, Ng discloses the first type of connector is a loop (see slot of 1027 fig 6).
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Annotated fig 9 of Ng.
With respect to claim 31, Ng discloses at least one strap of the headgear straps (1092, fig 9) includes a first width (see annotated fig 9 of Ng) and a second width (see annotated fig 9 of Ng) that is greater than the first width (see different widths in fig 9).
With respect to claim 32, Ng discloses the first width is selectively receivable through the first type of connector (see fig 1B through connector 1027), and wherein the second width is substantially blocked from passing through the first type of connector (second width is too large and would not fit through the connector and additionally the second width is spaced from the connector making the headgear too tight for the user to wear; fig 1B).
With respect to claim 35, Ng discloses at least one strap of the headgear straps (1092, fig 9) includes a cut edge (see annotated fig 9 of Ng) configured to provide a tactile response when passing through the first type of connector (tactile response from edge and Velcro on the edge; see [0125]).
With respect to claim 36, Ng discloses the cut edge includes a rectangular shape (see shape in annotated fig 9 of Ng).
With respect to claim 37, Ng discloses the pair of upper arms and the pair of lower arms are integrally formed with the central portion (see fig 6 and “integrally molded” [0101]).
With respect to claim 38, Ng discloses the plenum chamber includes at least one projection that extends from the groove, and wherein the central portion of the frame includes at least one slot configured to selectably receive the at least one projection (see [0187] and 1048/1055 in fig 5).
With respect to claim 39, Ng discloses the pair of lower arms are substantially flush with the central portion (note the lower arms 1025 are flush with and extend outwardly from the central portion of the frame).
With respect to claim 42, Ng discloses a system for providing pressurized air to a patient (mask system used for treatment; [0002]), the system comprising the patient interface of claim 16 (see claim 16 above); a respiratory therapy system (RPT) device configured to provide a flow of air at the therapeutic pressure (see [0003]); and a conduit (connected to air delivery tube; see [0168]) connecting the RPT device to the patient interface, the conduit configured to convey the flow of air to the patient interface; wherein the conduit is connected to the inlet port of the plenum chamber (via elbow 1070, fig 3).
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.
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) 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ng in view of Rummery (2014/0053844).
With respect to claim 20, Ng discloses the first type of connector is the loop, but lacks the loop including a first loop portion and a second loop portion adjacent to the first loop portion.
However, Rummery teaches a patient interface (32, fig 8a) comprising a connector (50, fig 8a) that is a loop (52/54, fig 8b) including a first loop portion (52, fig 8b) and a second loop portion (54, 8b) adjacent to the first loop portion (see fig 8b).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first connector of Ng to include a first and second loop as taught by Rummery so as to replace one known connector with another for attaching the strap to the interface.
With respect to claim 21, the modified Ng shows the loop includes a dividing wall (56, fig 8b of Rummery) at least partially dividing the first loop portion from the second loop portion (see fig 8b and [0192] of Rummery).
With respect to claim 22, the modified Ng shows a strap of the headgear straps is configured to be selectively inserted into the first loop portion and contact the dividing wall, in use while under an optimal tension (see [0192] of Rummery), and wherein the strap is configured to move into the second loop portion while under tension greater than the optimal tension (note the strap moves in the loops when tightening and when tension is applied).
Claim(s) 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ng and Rummery as applied to claim 22 above, and further in view of Scheiner (2018/0318539).
With respect to claim 23, Ng discloses the second type of connector (see claim 18 above) but lacks the second type of connector is a magnetic member.
However, Scheiner teaches a patient interface (6000, fig 5) comprising a connector (6130, fig 9) that is a magnet (6155, fig 9 and [0183]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the second connector of Ng with the magnetic connector as taught by Scheiner so as to replace one connector with another for attaching two structures to each other.
With respect to claim 24, the modified Ng shows the magnetic member includes a substantially elliptical shape (see shape of 6155 in fig 9 of Scheiner).
With respect to claim 25, the modified Ng shows a housing (6161, fig 6 of Scheiner) is removably and magnetically connected to the magnetic member (see [0183] of Scheiner).
With respect to claim 26, the modified Ng shows a strap connector (see loop portion on 6161 attached to strap 6804 fig 6 of Scheiner) for connecting to a strap of the headgear straps (6804 of Scheiner), the strap connector is selected from a loop (see loop of 6161 in fig 6 of Scheiner)
With respect to claim 27, the modified Ng shows the housing is configured to engage a lip of an outer casing (see the housing connection to 6130 and [0183]).
Claim(s) 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ng in view of Amarasinghe (CN108348722).
With respect to claim 28, Ng discloses all the elements as claimed above but lacks at least one strap of the headgear straps includes an elastic portion stretchable between a first position and a second position, and wherein the at least one strap includes an alerting portion configured to be visible in the second position and substantially hidden in the first position.
However, Amarasinghe teaches a patient interface (16100, fig 78) comprising a headgear strap (16804/16160, fig 103 and [0305] of Amarasinghe translation) including an elastic portion (see [0546] of Amarasinghe translation) stretchable between a first position (attached as seen in fig 103) and a second position (detached position, the user can stretch out the strap when detached), and wherein the at least one strap includes an alerting portion (visible 16155, fig 97 and 103 when clip 16160 is detached) configured to be visible in the second position (when strap is detached) and substantially hidden in the first position (when strap is attached).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the headgear of Ng to include the alerting portion as taught by Amarasinghe so as to allow the user to safely wear the interface and avoid over stretching.
With respect to claim 29, the modified Ng shows the at least one strap further includes a tactile response element (16155, fig 103 of Amarasinghe) includes a first portion (16155A/B/C, fig 97 of Amarasinghe) and a second portion (16160/16162, fig 103 of Amarasinghe) disposed on either side of the alerting portion (see 16155 between 16155A and 16160 in fig 103 of Amarasinghe), and wherein the first portion and the second portion of the tactile response element are connecting in the first position (see fig 103 of Amarasinghe where the elements are attached) and are configured to separate in the second position in order to alert the patient (the strap can disconnect and element 16155 would be visible alerting the patient of decoupling).
With respect to claim 30, the modified Ng shows the tactile response element is a magnet (see modification by Amarasinghe where 16155 is a magnet, fig 103 and [0305] of Amarasinghe translation).
Claim(s) 33-34 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ng in view of Swift (2012/0304999).
With respect to claim 33, Ng discloses all the elements as claimed above but lacks at least one strap of the headgear straps includes a plurality of raised portions configured to provide a tactile response when passing through the first type of connector.
However, Swift teaches a patient interface (5, fig 1) comprising headgear straps (230, fig 26) including a plurality of raised portions (230.2/230.6, fig 26) configured to provide a tactile response when passing through a connector (15, fig 2 and [0078]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the headgear of Ng to include a plurality of raised portions as taught by Swift so as to provide feedback to the user for easy positioning and adjustment of the strap (see [0078] of Swift).
With respect to claim 34, the modified Ng shows the plurality of raised portions are glue dots (silicone; see [0079] of Swift).
With respect to claim 41, Ng discloses all the elements as claimed above but lacks a textile sleeve is connected to each upper arm of the pair of upper arms.
However, Swift teaches a patient interface (700, fig 31) comprising upper arms (230, fig 31) and textile sleeves (708, fig 31) connected to each upper arm (on each side of the interface).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the upper arms of Ng to include textile sleeves as taught by Swift so as to provide a level of comfort to the patient e.g., to prevent or limit contact of strap with face and/or limit or prevent marks from the straps from appearing on the patient's face after long durations of use, e.g., 5-8 hours during the patient's sleep (see [0090] of Swift).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ng in view of Chodkowski (2016/0022944).
With respect to claim 40, Ng discloses all the elements as claimed above but lacks the seal-forming structure further includes a first seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's mouth; a second seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's nares.
However, Chodkowski teaches a patient interface (2, fig 1) comprising a seal forming structure (12, fig 1) including a first seal-forming structure (oral sealing portion; 40, fig 7) constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's mouth (see [0034]); a second seal-forming structure (nasal sealing portion; 44, fig 7) constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's nares (see [0034]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the seal forming structure of Ng to include separate nasal and oral sealing structures as taught by Chodkowski so as to keep the a tight seal around both the nose and mouth, allowing for ample airflow to the user.
Note after the modification the interface would show the groove is disposed on the plenum chamber inferior to the second seal- forming structure and opposite to the first seal-forming structure (see fig 3 of Ng).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rudolph (2008/0230068), Chang (2009/0223523), Dravitzki (2012/0138061), Formica (2013/0199537), Shafer (2017/0000964), Marshal (2017/0246411), and Goldspink (2018/0236200) are cited to show additional patient interfaces.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY E BALLER whose telephone number is (571)272-8153. The examiner can normally be reached Monday - Friday 8 AM - 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KELSEY E BALLER/ Examiner, Art Unit 3785
/TU A VO/ Primary Examiner, Art Unit 3785