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 an amendment filed on 12/11/2025. As directed by the amendment, no claims were canceled, claims 1-13 were amended, and no new claims were added. Thus, claims 1-13 are pending for this application.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
In claim 1 line 8, “sealingly connected to the sealingly connected to the exit port” should be changed to --sealingly connected to the exit port-- in order to correct the typographical error.
In claim 3 line 4-5, the phrase “a pressure differential between the inner surface ambient air” should be changed to --a pressure differential between the inner surface and the ambient air-- in order to correct the typographical error.
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 10-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 10, the phrase “the support strip being deformable” in line 8 is unclear as at least one support strips have been previously claimed, therefore in a case where multiple support strips are claimed it is not clear whether the limitation of the support strip being deformable applies to all of the support strips or just one of the support strips.
Regarding claim 11, the phrase “comprising a plurality of said resilient support strips” in line 2 is unclear how many resilient support strips are being claimed by applicant (i.e. does the invention include the resilient support strip of claim 10 as well as a plurality of resilient support strips (so at least three strips are claimed), or does applicant intend to claim that the invention only includes a plurality of resilient support strips (at least two strips claimed)?).
The remaining claims are rejected due to dependence on a rejected base claim.
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.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mayo (US 2015/0013680) in view of Hoppough (US 4,653,493).
Regarding claim 1, Mayo discloses (Fig. 1-2 and 10) a face mask system (Abstract) for removal of pathogens from exhaled air (“for removal of pathogens from exhaled air” interpreted as intended use, therefore because the structure of the invention of Mayo could be used to assist in removal of pathogens from exhaled air (i.e. due to fact Mayo includes one-way exhalation valve), the limitation is comprehended) comprising:
a face mask (mask 12) having at least one flexible layer (outer shell 20, described as “flexible” in paragraph [0048]) with an inner surface (internal surface having air pillow 23) configured to form sealed contact with a user's face (paragraph [0053]) and an outer surface (external surface connected to straps 18) exposed to an environment (see Fig. 1);
an inlet port (port in outer shell 20 having intake valve 22) in the at least one flexible layer (see Fig. 1);
an exit port comprising (exit port 24 and condensation tube assembly 14) in the at least one flexible layer (see Fig. 2);
an outflow chamber (collection bag 32) sealingly connected to the exit port (sealingly connected due to exit port not allowing for reverse flow, paragraph [0052]); and
a oneway exit valve (exit port 24 which acts as a one-way valve by only allowing one-way movement of air, paragraph [0052]) within the exit port that opens in response to exhalation by the user and closes during inhalation (paragraph [0052]).
Mayo does not disclose wherein the outflow chamber is deformable.
However, Hoppaugh teaches (Fig. 1-2) an outflow chamber (containment bag 16) for a breathing system that is deformable (“flexible”, Col. 4 lines 19-25).
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 outflow chamber of Mayo to be deformable, as taught by Hoppaugh, for the purpose of allowing the volume of the bag to be adjusted based on the volume of exhaled air entering the bag.
Regarding claim 2, modified Mayo discloses the exit port is of a diameter that is dimensioned not to impede the flow of exhaled air through the oneway exit valve (exit port allows air to enter deformable chamber via the one-way exit valve and thus is dimensions not to impede the flow. See paragraph [0052] and [0057] of Mayo), but does not disclose the diameter is about 40 mm. However, outside evidence of criticality, one of ordinary skill in the art before the effective filing date of the claimed invention would find it obvious to try a dimeter of 40 mm for the purpose of selecting a diameter large enough to not to impede exhaled flow through the oneway exit valve, since discovering the optimum value only involves routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 3, modified Mayo discloses wherein the inlet port comprises a oneway inlet valve (inlet valve 22 Mayo) that opens when the user inhales (paragraph [0050] Mayo) and closes when the user exhales in response to a pressure differential between the inner surface and the ambient air (paragraph [0050]-[0051]).
Regarding claim 9, modified Mayo discloses wherein an outflow from the exit port to the deformable outflow chamber is a low resistance path (Mayo discloses collecting exhaled air and vapor in a bag and thus outflow from the exit port to the deformable outflow chamber is a low resistance path), and discloses a one-way exit valve (exit port 24 which acts as a one-way valve by only allowing one-way movement of air, paragraph [0052] Mayo) that opens in response to exhalation by the user and closes during inhalation (paragraph [0052] Mayo), but does not disclose that the oneway exit valve opens at a differential pressure no greater than about 10 mmH2O. However, outside evidence of criticality, one of ordinary skill in the art before the effective filing date of the claimed invention would find it obvious to try a differential pressure no greater than about 10 mmH2Ofor the purpose of selecting a pressure level that is small enough for users with weak lungs but large enough to prevent backflow of gas, since discovering the optimum value only involves routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Mayo (US 2015/0013680) in view of Hoppough (US 4,653,493), and further in view of Hickle (US 2002/0017299).
Regarding claim 4, modified Mayo discloses a deformable chamber, but does not disclose the system further comprising a processing unit fluidly connected to the deformable outflow chamber by a flexible conduit and configured to remove or inactivate pathogens from exhaled air.
However, Hickle teaches (Fig. 1-10B) a system comprising a processing unit (scavenger system 48) fluidly connected to a deformable outflow chamber (expiratory plenum 180) by a flexible conduit (scavenging line 85) and configured to remove or inactivate pathogens from exhaled air (via filter 86, paragraph [0107]).
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 system of modified Mayo such that the system further comprising a processing unit fluidly connected to the deformable outflow chamber by a flexible conduit and configured to remove or inactivate pathogens from exhaled air, as taught by Hickle, for the purpose of treating and releasing the exhausted gases to a safe location (paragraph [0061] Hickle).
Regarding claim 6, modified Mayo does not disclose a suction device coupled to an exhaust outlet and configured to draw exhaled air from the deformable outflow chamber through the processing unit.
However, Hoppaugh teaches (Fig. 1-2) discloses a suction device (vacuum source 22) coupled to an exhaust outlet (outlet 102) and configured to draw exhaled air from the deformable outflow chamber through the processing unit
a deformable outflow chamber (16) sealingly connected (Col. 4 lines 22-25 and 42-48) to a suction device (vacuum source 22) by means of a conduit (connecting hose 18), said conduit configured to transport expelled matter from the user via the exit port of the at least one layer and the deformable outflow chamber (Col. 4 lines 37-56).
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 system of modified Mayo such that the deformable outflow chamber is sealingly connected to a suction means by means of a conduit, said conduit configured to transport expelled matter from the user via the exit port of the at least one layer and the deformable outflow chamber, as further taught by Hoppaugh, for the purpose of providing a way to remove the excess exhaust air so that the outflow chamber does not overinflate and burst or cause pressure imbalances.
Regarding claim 7, wherein a controller varies operation of the suction device to set a flow rate through a path of exhaled air (paragraph [0107] Hickle), but does not disclose the controller operating in response to feedback from the pressure sensor located along the path of exhaled air.
However, Hickle further teaches (Fig. 9A) a controller (controller 14) operating in response to feedback from the pressure sensor (pressure sensor 166) located along the path of exhaled air (expiratory line of airway circuit 20, see paragraph [0093]).
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 system of modified Mayo such that the controller operating in response to feedback from the pressure sensor located along the path of exhaled air, as taught by Hickle, for the purpose of determining whether the expiratory line is occluded so that measures can be taken to remove blockage, thereby reducing liklihood of patient injury.
Regarding claim 8, modified Mayo does not disclose wherein the processing unit includes a safety valve that, in response to sensed pressure, opens to admit ambient air through an inlet pipe when pressure is below a threshold or opens an overpressure line through a filter when pressure exceeds a threshold.
However, Hickle teaches (Fig. 1-10B) the processing unit includes a safety valve (EPPRV valve 164 ) that, in response to a sensed pressure, opens to let ambient air through a filter (filter 175) when pressure exceeds a threshold an over-pressure line (paragraph [0097]).
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 system of modified Mayo such that the processing unit includes a safety valve that, in response to sensed pressure, opens an overpressure line through a filter when pressure exceeds a threshold, as taught by Hickle, for the purpose of removing the exhaled air and vapor from the system so that it does not stay trapped in the system, and additionally filtering this air so that it does not contaminate the environment.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mayo (US 2015/0013680) in view of Hoppough (US 4,653,493), and further in view of Hickle (US 2002/0017299), and further in view of Wood (US 2010/0319699).
Regarding claim 5, modified Mayo does not disclose wherein the processing unit comprises a valve and a pressure sensor.
However, Hickle further teaches (Fig. 9A) a processing unit (controller 14) comprises a valve (primary expiratory valve 168) and a pressure sensor (pressure sensor 166, paragraph [0093]).
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 processing unit of modified Mayo to include a valve and pressure sensor, as taught by Hickle, for the purpose of determining whether the expiratory line is occluded so that measures can be taken to remove blockage, thereby reducing liklihood of patient injury.
Modified Mayo discloses the processing unit comprising a filter assembly (filter 86 within scavenging line 85 of scavenging pump system 48 of Hickle), but does not disclose the processing unit filter assembly comprises an electrostatic desposition subunit and a filter downstream of the electrostatic deposition subunit.
However, Wood teaches (Fig. 1) a filter assembly comprising an electrostatic deposition subunit (electrostatic filter pad 10) and a filter (filter 8) downstream of the subunit (see directional arrow A and paragraph [0022]).
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 filter assembly of the processing unit of modified Mayo to include an electrostatic desposition subunit and a filter downstream of the electrostatic deposition subunit, as taught by Wood, for the purpose of preventing liquid particles from reaching the filter and thus improving life of filter (paragraph [0022]).
Claim 10-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hoppough (US 4,653,493) in view of Mayo (US 2015/0013680) and Boba (US 3,773,045).
Regarding claim 10, Hoppough discloses (Fig. 1-2) an outflow chamber apparatus comprising:
a lightweight deformable chamber (containment bag 16, described as flexible and thus deformable. Regarding “lightweight”, paragraph [0048] of applicant’s specification states the outflow chamber is formed of “a very flexible thin walled plastic chamber”, and Hoppough discloses the bag 16 is a “conventional flexible bag manufactured from a gas impermeable material, such as a polymeric or rubber compound”, Col. 4 lines 19-23, and thus would be interpreted to be lightweight) defining an interior volume;
a one way inlet (inlet line 14 of bag 16 that includes one way check valve 40) for sealed connection (sealing adhesive, Col. 4 lines 23-25) to an outlet of a face mask (sealed to an outlet of a patient breathing device, see Fig. 1. While a face mask is not disclosed, this limitation is interpreted as intended use, and because the structure of Hoppough would be capable of performing this claimed function, the limitation is comprehended);
wherein the chamber is configured to expand in volume in response to positive internal pressure and to contract toward a resting volume when internal pressure decreases (volume increasing as pressure increases due to more exhaled air entering back, and decreases as suction device removes air from bag and system. Col. 3 lines 42-48).
Hoppough does not disclose a oneway outlet valve spaced from the oneway inlet.
However, Mayo teaches teaches (Fig. 1-2 and 10) an outflow chamber (collection bag 32, paragraph [0057]) including a one-way inlet (exit port 24, which acts as a valve by allowing one-way movement of air, paragraph [0052]) and a one way outlet valve spaced from the inlet (pressure escape valve 28, located distal to exit port 24).
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 outflow chamber of Hoppough to include a oneway outlet valve spaced from the oneway inlet, as taught by Mayo, for the purpose of releasing pressure when the pressure inside the flexible bag becomes too great (paragraph [0058] Mayo).
Modified Hoppough does not disclose wherein the chamber exhibits variable compliance provided by at least one resilient support strip attached to a surface of the chamber, the support strip being deformable from a first concave shape to a second convex shape relative to the chamber so as to (i) urge the chamber to a larger internal volume when internal pressure rises, and (ii) bias the chamber toward its resting volume when internal pressure falls.
However, Boba teaches (Fig. 4) a flexible outflow chamber (bag 10) that exhibits variable compliance provided by at least one resilient support strip (strips 13-16) attached to a surface of the chamber (strips are vertical and attached to the outer surface of bag, Col. 3 lines 19-22, and deform based on the level of pressure within bag to provide an indication to user as to level of inflation of bag, Col. 3 lines 1-22), the support strip being deformable from a first concave shape to a second convex shape relative to the chamber (shape of strips depends on shape of chamber and thus changes in shape occur relative to the chamber) so as to (i) urge the chamber to a larger internal volume when internal pressure rises, and (ii) bias the chamber toward its resting volume when internal pressure falls (support strips begin as concave due to deflated state of bag of Hoppough as shown in Annotated Fig. 2 of Hoppough below, and transition to convex when the bag inflates more. Urging occurs due to being on the exterior of bag and attached to outer surface. When bag deflates, strips return to original concave position).
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[AltContent: textbox (Annotated Fig. 2 of Hoppough)]
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 outflow chamber of modified Hoppough the chamber exhibits variable compliance provided by at least one resilient support strip attached to a surface of the chamber, the support strip being deformable from a first concave shape to a second convex shape relative to the chamber so as to (i) urge the chamber to a larger internal volume when internal pressure rises, and (ii) bias the chamber toward its resting volume when internal pressure falls, as taught by Boba, for the purpose of providing an indication to user as to level of inflation of bag (Col. 3 lines 1-22 Boba).
Regarding claim 11, modified Hoppough dislcoses a plurality of the resilient support strips (plurality of strips 13-16 shown in Fig. 4 Boba).
Regarding claim 13, modified Hoppough discloses wherein the oneway outlet valve is distal the oneway inlet (pressure escape valve 28 of Mayo, located distal to exit port 24 of Mayo) and sized to permit passive selfemptying of the chamber though a downstream low resistance filter between exhalations (low resistance filter 26 that permits passive self emptying in case of failure of vacuum source, Col. 5 lines 25-45 Hoppough).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hoppough (US 4,653,493) in view of Mayo (US 2015/0013680) and Boba (US 3,773,045), and further in view of Robbins (US 2007/0037665).
Regarding claim 12, modified Hoppough discloses a plurality of resilient support strips, but does not disclose the strips have different stiffnesses such that each transitions from the fist concave shape to the second convex shape at a different internal pressure of the chamber.
However, Robbins teaches (Fig. 5) a plurality of resilient support strips (resistance elements 36) that have different stiffnesses (different thicknesses which result in different stiffnesses, paragraph [0038]). Regarding the limitation “such that each transitions from the fist concave shape to the second convex shape at a different internal pressure of the chamber”, the combined modified Hoppough/Robins invention provides for this feature due to modified Hoppough providing the structure of the chamber and strips and Robbins used merely to teach changing the thicknesses so that a different resistance profile is achieved.
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 strips of modified Hoppough so that the strips have different stiffnesses such that each transitions from the fist concave shape to the second convex shape at a different internal pressure of the chamber, as taught and suggested by Robbins, for the purpose of widening the range of resistance of the strips and thus providing for improved variable compliance of the chamber (paragraph [0038] Robbins).
Response to Arguments
Applicant’s arguments filed 12/11/2025 have been considered but are not persuasive.
Regarding rejection of claim 1, applicant argued (page 8 paragraph 1 Remarks) that Mayo addresses vapor collection/condensation for hydration and expressly provides a pressure-relief valve because its path accumulates pressure, and thus teaches away from a mask-front, very-low-resistance sneeze path. Applicant further argues that Hoppough is a ventilator side scavenging device relying on facility vacuum and is thus not a patient-worn mask architecture that captures explosive cough/sneeze boluses without faceseal blowby, and Hickle is a broad systems disclosure of scavenging/processing and does not supply the claimed low-opening-pressure exit valve and variable-compliance outflow chamber.
Examiner respectfully disagrees.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a mask-front, very-low-resistance sneeze path, patient-worn mask architecture that captures explosive cough/sneeze boluses without faceseal blowby, low-opening-perssure exit valve and variable-compliance outflow chamber) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to Applicant' s argument that Mayo teaches away from a mask-front, very-low-resistance sneeze path, it is noted that a teaching away requires a reference to actually criticize, discredit, or otherwise discourage investigation into the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). It has been further instructed that the Examiner will not read into a reference a teaching away from a process where no such language exists. See DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006).
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 R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
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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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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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