DETAILED ACTION
This Office Action is in response to the filing of an amendment to the claims on 5/16/2025. As per the amendment, claims 155-156 have been amended, and no claims have been added or cancelled. Thus, claims 155-162 are pending in the application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 155-161 are rejected under 35 U.S.C. 103 as being obvious over Nelson et al. (US Pat. 11,826,509) in view of Holley et al. (US Pat. 11,160,941) in view of Thornton (US Pub. 2007/0006879).
Regarding claim 155, Nelson discloses a method comprising: providing a flow of gas to a patient through a patient interface apparatus (see the respiratory therapy system of Fig. 1, having a gas source 3 that is provided to a user interface 7 via a breathing gas delivery conduit 29) such that, during a portion of a breathing cycle of a patient: a first flow path (flow path F1 in Fig. 5b) is provided from an inlet of the patient interface apparatus (see Figs. 1 and 5b where flow path F1 comes from conduit 29 into elbow connector 111), through a nose of the patient (see nasal prongs 123 in Fig. 5b), out of the patient (see Col. 11 lines 53-63 where flow F1 flushes dead space and is expelled from the respiratory tract), and out a gas outlet of the patient interface apparatus (see vent arrangement 151 with vent holes 153 in Figs. 10a-10b); a second flow path is provided from the inlet to the gas outlet without passing through the nose or the mouth of the patient (see flow F2 in Fig. 5b); and wherein the patient interface apparatus resists flow along the second flow path such that the first flow path provides flushing of anatomical dead space of the patient during the portion of the breathing cycle of the patient (see Col. 10 line 66 to Col. 11 line 5, and Col 11 lines 17-20 where flow F2 is a higher pressure flow that better resists air flow and creates a seal in the patient interface, while flow F1 provides flushing of anatomical dead space during the breathing cycle).
Nelson lacks a detailed description of wherein the first flow path goes through a mouth of the patient and out of the nose of the patient, to provide flushing of anatomical dead space.
However, Holley teaches a similar dead space flushing respiratory system, where pressurized gas is delivered via the mouth of a patient to reduce anatomical dead space (see Figs. 12-19 and Col. 8 lines 38-43) and can then flow out of the nasal cavity (see Col. 8 lines 55-58) to flush anatomical dead space (see Col. 11 lines 16-30).
Therefore 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 flow paths of Nelson such that the flow F1 for flushing dead space is supplied to the mouth rather than the nostrils, as taught by Holley, as it would be a matter of design choice for one of ordinary skill in the art to choose which breathing orifice (nose or mouth) that the positive pressure flushing flow is applied to, while also having the benefit of the mouth allowing for the gas being supplied towards the posterior end for more effective flushing of dead space (Holley; see Col. 11 lines 30-35). It is understood that in the modified Nelson device, it is only the flow path direction that is adjusted, and the modified device does not include the intra-oral tubing of Holley.
The modified Nelson device lacks a detailed description of wherein no portion of the patient interface is configured to enter an oral or a nasal cavity of the patient.
However, Thornton teaches an oronasal mask, where the nasal flow path has a nasal portion with a flow path openings that is outside of the nostrils (see Figs. 2A-2B where upper chamber 108 has openings 112 which allow for the free flow of air between the upper chamber and the nose, but where openings 112 do not enter the nostrils).
Therefore 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 nasal prongs of the modified Nelson device to instead be the upper chamber and nasal openings as taught by Thornton, as it would be a simple substitution of one type of air delivery aperture for another, to yield the predictable result of providing a flow path of air through the nose, as well as not having to worry about the nasal prong irritating the nasal membranes.
Regarding claim 156, the modified Nelson device has wherein the first flow path and the second flow path are provided during or after exhalation of the patient (Nelson; see Col. 11 lines 48-63 where the removal of expelled dead space gas through the vents of the patient interface is the exhalation phase) while the mouth of the patient is open (Holley; see Col. 8 lines 31-43 where the reduction of dead space requires a flow of pressurized gas into the oral cavity, and thus the mouth is at least partially open).
Regarding claim 157, the modified Nelson device has wherein the patient interface apparatus comprises: a sealing mask forming a seal with a mouth and a nose of the patient (Nelson; see user interface 7 comprises mask body 103 and mask cushion 105 which is an oronasal mask); a first chamber in fluid communication with the mouth of the patient (Nelson; see Fig. 5b where nasal cannula assembly 113 is modified by Thornton (see Figs. 2A-2B upper chamber 108), which is further modified in light of Holley to be a flow path leading to the oral cavity); a second chamber in fluid communication with the nose of the patient (Nelson; see Fig. 5b where when modified by Holley, the flow F2 that leads into the space of the mask interacts with the mask space, and thus also the nose of the patient, which is not covered by a nasal cannula in light of the modification of Holley and Thornton); a dividing wall at least partially separating the first chamber from the second chamber (Nelson; see Fig. 5b, where the wall of the nasal cannula assembly 113 are modified to be an upper chamber as taught by Thornton, which acts as a wall that divides the first chamber (upper chamber 108 in Figs. 2A-2B of Thornton) from the second chamber (the interior mask space of Nelson)); a gas inlet fluidly connected to the first chamber (Nelson; see Fig. 2 inlet 109 leading to the oral cavity as modified by Holley); and a gas outlet fluidly connected to the second chamber (Nelson; see Figs. 10a-10b vent holes 153 which connect to the interior chamber space of the mask).
Regarding claim 158, the modified Nelson device has wherein the gas outlet further causes a pressure of the second chamber to be less than the pressure of the first chamber (Holley; see Col. 9 lines 24-36 where the oral interface operates at a low pressure for dead space flushing, and in the modified Nelson device, the mask interior has vent holes (Fig. 10a-10b vent holes 153) which vent to atmosphere, thus further reducing the pressure within the mask interior).
Regarding claim 159, the modified Nelson device has wherein the dividing wall further causes the pressure of the second chamber to be less than the pressure of the first chamber (Nelson; see Fig. 5b, where the nasal cannula 113 (as modified to be the upper chamber 108 in Figs. 2A-2B of Thornton) has walls which divide the two chambers, with vent holes for the two flow paths (Nelson; see Figs. 4a-4d vent holes 125) which lead to exhaust vent holes (Nelson; see Figs. 10a-10b vent holes 153) and thus the walls of the tubing cause the split in the airflow which leads to a lower pressure in the mask chamber. Additionally, it would appear that the claimed invention and the modified prior art of record have the same structure as claimed, and thus would have equal flow dynamics and characteristics).
Regarding claim 160, the modified Nelson device has wherein the dividing wall further causes the pressure of the second chamber to be less than the pressure of the first chamber (Nelson; see Fig. 5b, where the nasal cannula 113 (as modified to be the upper chamber 108 in Figs. 2A-2B of Thornton) has walls which divide the two chambers, with vent holes for the two flow paths (Nelson; see Figs. 4a-4d vent holes 125) which lead to exhaust vent holes (Nelson; see Figs. 10a-10b vent holes 153) and thus the walls of the tubing cause the split in the airflow which leads to a lower pressure in the mask chamber. Additionally, it would appear that the claimed invention and the modified prior art of record have the same structure as claimed, and thus would have equal flow dynamics and characteristics).
Regarding claim 161, the modified Nelson device has wherein the gas outlet comprises a bias vent (Nelson; see Figs. 10a-10b vent holes 153, which bias to atmosphere).
Claim 162 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Holley in view of Thornton as applied to claim 157 above, and further in view of Tatkov (US Pat. 10,556,079).
Regarding claim 162, the modified Nelson device has the gas outlet.
The modified Nelson device lacks a detailed description of wherein the gas outlet is configured to connect to an expiratory limb.
However, Tatkov teaches a similar mask system for delivering gas to the user, where exhaled gas is taken by an expiratory limb (see Col. 13 lines 54-62).
Therefore 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 outlet of the modified Nelson device to be an expiratory limb as taught by Tatkov, as it would be a simple substitution of one means for removing the exhaled gas for another, with the benefit of allowing the exhaled gas to be pulsed to a ventilator that can regulate the pressure within the user interface (Tatkov; see Col. 13 lines 54-62).
Response to Arguments
Applicant’s arguments with respect to claims 155-162 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record. Specifically, the newly applied Thornton reference is understood to teach a nasal access flow path that does not enter the nose.
Applicant argues on pages 7-8 that the modification of Nelson in view of Holley relies on impermissible hindsight, and are entirely different principles of operation where Holley describes only a single flow path. The arguments are not well-taken. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Further, Holley is not a different principle of operation, as both Nelson and Holley deliver pressurized gas to the respiratory tract of a patient, through an orifice. Rather, the main substantive difference argued is that Holley is only one flow path directed to a mouth, rather than a dual flow path system as disclosed in Nelson. However, the teachings of Holley, whereby a flow path can be guided to a mouth in order to reduce dead space, comes directly from the teachings of Holley where the benefits are clear to a person of ordinary skill in the art. Additionally, the interpretation in view of Holley has been adjusted due to the inclusion of the Thornton reference, such that Holley only teaches the flow path direction for flushing a dead space, and not the inclusion of a mouthpiece and tubes for oral delivery. The opening of the mouth and the impedance of Holley are not part of the modified Nelson device.
Applicant argues on pages 9-10 that the modification of Nelson in view of Holley for claim 157 is drastic as it requires a substantial redesign of the elements of Nelson. The argument is moot in light of the teachings in view of Thornton.
For the reasons above, the rejections hold.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Thurs 9:00-6:00.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785
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