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 Arguments
Applicant's arguments filed 01/26/2026 have been fully considered but they are not persuasive.
Applicant argued on page 6 of Remarks that if the central region of the lid 109 of Persson (US 20110220108 A1) was modified to comprise the central inlet of Leitbitzki (WO 2015067234 A2) then the valve of Persson would not close airflow entering the valve and would not "closingly engage the valve seat in the closed position," as required by Persson, the openings (on the side and the purported opening in the lid) would not be closed when the cover is pressed downward, as required by Persson, pushing the lid 109, 209 downward would not "close the communication between the trachea and the surroundings," as required by Persson, pushing the lid 109, 209 would not have a closing effect as the central inlet would remain open and unaffected, and the air would pass through the device and into the trachea and prevent the air from flowing through a voice prosthesis into the pharynx. The examiner respectfully disagrees. Persson in view of Leibitzki teaches a central inlet, wherein the central inlet (taught by Leibitzki) comprises a boss 111 (taught by Persson) surrounding the central inlet which provides guidance for the user to locate and push the circular lid 109 to be displaced towards the proximal end of the housing for a closing effect as seen in Figs. 1-2a and [0046] of Persson. When a user presses their finger on the boss 111 (see [0022] of Persson), the central inlet will be blocked by the user’s finger to prevent airflow (see page 5, paragraphs 4-7 of Leibitzki). Furthermore, the apertures 108 will be closed due to the lid 109 being pressed down until it sits on valve seat 105 as seen in [0022] of Persson. As such, Persson in view of Leitbitzki teaches the valve of Persson would closingly engage the valve seat, and the openings and central inlet would be closed when a user presses their finger to cover the central inlet guided by the boss 111 of Persson and depress lid 109 downwards to sit on valve seat 105 to close first opening 101 (see [0022]). Therefore, the combination of Leitbitzki in view of Persson does not teach away from Persson as lid 109 will still be depressed to close openings 101 and the user’s finger would be used to cover the central inlet to close/prevent airflow into the trachea. Furthermore, Persson already teaches using a finger to add pressure to lid 109 until the lid 109 sits or rests on valve seat 105 (see [0022]).
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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.
Claim(s) 1, 6, 10, 12-13, 16 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Persson (US 20110220108 A1) in view of Leibitzki (WO 2015067234 A2; machine translated 9/12/2025).
Regarding claim 1, Persson teaches a breathing protector for use in a stoma of a laryngectomized or tracheotomised person (“The device according to one embodiment of the invention is shown in FIGS. 1, 2a and 2b, said device comprising a cylindrical filter housing 100. The device may be a breathing protector for use in a stoma of a laryngectomized or tracheotomised person.” See [0017]), said breathing protector comprising;
a housing (cylindrical filter housing 100, see Fig. 1) comprising a wall extending between a proximal end and a distal end (housing 100 has a wall extending between a proximal end and a distal end) and having
at least one side inlet (apertures 108, see Fig. 1) formed in the wall (apertures 108 is formed in the wall as seen in Figs. 1-2b) and at least one outlet (second opening 102, see Fig. 1) formed in the proximal end (second opening 102 is formed in the proximal end as seen in Figs. 1-2b),
a heat and moisture exchanger (HME) (heat-moisture exchanging filter 103, see Fig. 1), wherein said HME is arranged within and enclosed between the proximal end and the distal end of said housing (the heat-moisture exchanging filter is arranged within and enclosed between the proximal and the distal end of cylindrical filter housing 100 as seen in Figs. 1-2b),
a closing member (circular lid 109, see Fig. 1) arranged in a traversal plane to a central axis of the housing with the closing member defining the distal end of said housing (the circular lid 109 may be arranged in a transversal plane to the central axis of the housing (see [0020]), is at a distal open end of said housing as the circular lid 109 covers the top of the cylindrical filter housing 100 as seen in Fig. 2a), arranged distally of said HME (circular lid 109 is arranged distally of heat-moisture exchanging filter 103 as seen in Fig. 1, as the proximal end is where second opening 102 is located), with the closing member including a protrusion (protrusions 110, see Fig. 1) that engages with an inner surface of the wall of the housing to retain the closing member within the housing (“The circular lid 109 may also be peripherally provided with radially extending protrusions 110, said protrusions 110 engaging with the apertures 108…” see [0020]), and
wherein, when said closing member is in an open position, the airflow in use will pass from surroundings of said user through said at least one side inlet of said housing, pass through said HME and further to said at least one outlet, into a trachea of said person (when circular lid 109 is an open position as seen in Fig. 1, breathing air will enter through inlet apertures 108/first opening 101 (see [0019]) and out through second opening 102 (see [0018]) during inhalation into the trachea of said patient as seen in [0018]).
but does not explicitly teach a central inlet formed at a center of said closing member,
wherein the central inlet of said closing member allows a user to both locate the closing member and block airflow into the central inlet when said closing member is displaced toward the proximal end of the housing to close the at least one side inlet formed in the wall of the housing,
wherein, when said closing member is in an open position, the airflow in use will pass from surroundings of said user through said at least one side inlet of said housing and said central inlet of said closing member, pass through said HME and further to said at least one outlet, into a trachea of said person.
However, Leibitzki teaches a central inlet (through hole 42, see Figs. 2a-2c) formed at a center of said closing member (cover 4, see Figs. 2a-2c) (through hole 42 is formed at a center of cover 4 as seen in Fig. 2).
Leibitzki teaches a kit for a tracheostoma patient, including a rotationally symmetric housing 2, a sponge-like ventilation filter 3 and a lid 4 (see page 8, first paragraph). Leibitzki further teaches air passage openings 43 on the side and a second valve seat for a disc 5 (see page 8, last paragraph). Wherein by pressure of a finger, the disc 5 moves towards a close position as seen in Fig. 2c (see page 5, paragraphs 4-7). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the breathing protector taught by Persson to include a central inlet formed at a center of said closing member as taught by Leibitzki as it is known in the art to have a central inlet on the cover. Persson in view of Leibitzki teaches wherein the central inlet of said closing member allows a user to both locate the closing member and block airflow into the central inlet when said closing member is displaced toward the proximal end of the housing to close the at least one side inlet formed in the wall of the housing (Persson in view of Leibitzki teaches a central inlet, wherein the central inlet (taught by Leibitzki) comprises a boss 111 (taught by Persson) surrounding the central inlet which provides guidance for the user to locate and push the circular lid 109 to be displaced towards the proximal end of the housing for a closing effect as seen in Figs. 1-2a and [0046] of Persson. When a user presses their finger on the boss 111 (see [0022] of Persson), the central inlet will be blocked by the user’s finger to prevent airflow. Furthermore, the apertures 108 will be closed due to the lid 109 being pressed down until it sits on valve seat 105 as seen in [0022] of Persson),
wherein, when said closing member is in an open position, the airflow in use will pass from surroundings of said user through said at least one side inlet of said housing and said central inlet of said closing member, pass through said HME and further to said at least one outlet, into a trachea of said person (when circular lid 109 of Persson is an open position as seen in Fig. 1, breathing air will enter through both the central inlet (taught by Leibitzki) and inlet apertures 108/first opening 101 (see [0019] of Persson) and out through second opening 102 (see [0018] of Persson) during inhalation into the trachea of said patient as seen in [0018] of Persson).
Persson’s Annotated Fig. 1
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Regarding claim 6, Persson in view of Leibitzki teaches the breathing protector of claim 1, and further teaches wherein said closing member is provided with a rim interface structure (boss 111, see Fig. 1 and 2a) laterally surrounding said central inlet and projecting in a distal direction relative to said closing member (boss 111 laterally surrounds the central inlet and projects in a distal distance relative to the circular lid 109 as seen in Fig. 1).
Regarding claim 10, Persson in view of Leibitzki teaches the breathing protector of claim 1, and Persson further teaches wherein said housing is provided with a closing valve seat (valve seat 105, see Fig. 1) surrounding said HME (the valve seat 105 surrounds the heat-moisture exchanging filter 103 as seen in Fig. 1), and said closing member is provided with a closing valve (circular lid 109 is also a valve member as seen in [0020]), wherein said closing valve is adapted to seal against the closing valve seat and block the at least one side inlet formed in the walt and close the airflow to the at least one outlet (circular lid 109 is adapted to sit on valve seat 105 to close/cover said first opening 101, therefore closing/sealing the communication between the trachea and the surroundings as seen in [0022], resulting in blocked apertures 108 and closed airflow to second opening 102 as both aperture 108 and second opening 102 are inlets/outlets as seen in [0018]- [0019]).
Regarding claim 12, Persson in view of Leibitzki teaches the breathing protector of claim 1, and Persson further teaches wherein the HME comprises foam (“The heat-moisture exchanging filter 103 is of a flexible/resilient material, such as a resilient foam.” See [0022]).
Regarding claim 13, Persson in view of Leibitzki teaches the breathing protector of claim 12, and Persson further teaches wherein said foam is structured and arranged to act as a return spring for the closing member (“Thus, the heat-moisture exchanging filter 103 acts both as heat-moisture exchanger and return spring, pressing the lid 109 axially and distally into the open position.” See [0022]).
Regarding claim 16, Persson in view of Leibitzki teaches the method of claim 1, and Persson further teaches wherein said HME is configured to act is a return spring for said closing member (“Thus, the heat-moisture exchanging filter 103 acts both as heat-moisture exchanger and return spring, pressing the lid 109 axially and distally into the open position.” See [0022]).
Regarding claim 21, Persson in view of Leibitzki teaches the breathing protector of claim 1, and Persson further teaches wherein the protrusion of the closing member extend radially and engage with at least one side inlet formed in the wall of the housing (“The circular lid 109 may also be peripherally provided with radially extending protrusions 110, said protrusions 110 engaging with the apertures 108…” see [0020]).
Claims 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Persson (US 20110220108 A1) in view of Leibitzki (WO 2015067234 A2), as applied to claim 1 above, and further in view of Depel (US 4582058 A).
Regarding claim 3, Persson in view of Leibitzki teaches the breathing protector of claim 1, but does not further teach wherein said central inlet in the closing member is provided with at least one dividing bar.
However, Depel teaches wherein said central inlet in the closing member is provided with at least one dividing bar (cover 4 (taken as closing member) is in the form of a spider 24 which comprises of four dividing bars and results in a plurality of openings 23 (taken as central inlet) which permits air to be inhaled into the valve assembly as seen in Col. 4, lines 1-7 and Figs. 2-4).
Depel teaches a tracheostoma valve assembly 1, comprising a cylindrical-shaped central body 3, a cover or end cap 4 on one end, valve member 6 and a spring 9 as seen in Col. 3, lines 4-17 and Fig. 4. Similarly, to Persson, Depel teaches the valve member moving between an open and closed position using the spring as seen in Col. 4, lines 55-67. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the breathing protector taught by Persson in view of Leibitzki to have the closing member include the four dividing bars in the central inlet taught by Depel as an alternative design choice that does not affect the function of the device.
Regarding claim 4, modified Persson teaches the breathing protector of claim 3, and further teaches wherein said central inlet in the closing member is provided with a plurality of dividing bars (Modified Persson teaches the central inlet (taught by Leibitzki) within a circular lid 109 (see Fig. 1 of Persson) with a plurality of dividing bars as taught by Depel (see Figs. 2-4 and Col. 4, lines 1-7 of Depel).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Persson (US 20110220108 A1) in view of Leibitzki (WO 2015067234 A2), as applied to claim 1 above, and further in view of in view of Chmielinski (US 5022394 A).
Regarding claim 5, Persson in view of Leibitzki teaches the breathing protector of claim 1, but does not teach wherein said closing member further comprises plurality of inlets formed radially outside of said central inlet.
Chmielinski teaches a heat and moisturing device 10 for a patient having a tracheostomy (see Fig. 1 and Col. 2, lines 41-44). Chmielinski further teaches a plurality of slotted openings 56 (taken as plurality of inlets) are formed in the disc portion (taken as closing member) to permit passage of gas from the atmosphere through the exchange material, wherein the plurality of openings may be of any suitable size and shape to permit the passage of the gas as seen in Col. 3, lines 56-61). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the breathing protector taught by Persson in view of Leibitzki to include a plurality of openings on the closing member as taught by Chmielinski as a design choice that will not affect the function of the device.
With respect to Claim 5, modified Persson teaches wherein said closing member further comprises plurality of inlets (taught by Chmielinski) but does not explicitly teach wherein said closing member further comprises plurality of inlets formed radially outside of said central inlet. However, it has been held that the mere rearrangement of parts does not constitute a patentable improvement in the art when said rearrangement of parts does not result in a non-obvious change in functionality (see MPEP § 2144.04. VI. C). In this case, it is unclear why rearranging the plurality of inlets to be formed radially outside the central inlet would substantially change the functionality of the device in a non-obvious way. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify the breathing protector to have said closing member further comprises plurality of inlets formed radially outside of said central inlet, since it has been held that the rearrangement of parts involves only routine skill in the art. Furthermore, the applicant has placed no criticality on the design/arrangement of inlets as Figs. 1, 3 and 4 show a different closing member design for the inlet(s).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Persson (US 20110220108 A1 in view of Leibitzki (WO 2015067234 A2), as applied to claim 1 above, and further in view of) in view of Lambert (US 20030029456 A1).
Regarding claim 9, Persson in view of Leibitzki teaches the breathing protector of claim 1, but does not teach wherein said closing member is made of a non-flexible material configured to resist deformation due to pressure applied by the user.
However, Lambert teaches wherein said closing member is made of a non-flexible material configured to resist deformation due to pressure applied by the user (Lambert teaches cover plate 8 to be made of hard material as seen in [0028] and therefore can resist deformation due to pressure applied by the user).
Lambert teaches a breathing protector for a person with tracheostoma which adheres around a stoma 4 as seen in [0027] and Figs, 8-9. The breathing protector comprises a cylindrical heat-moisture exchanger body 6 with a cover plate 8 that although is preferred to be made of soft elastic plastic material, can be made out of hard OR soft material as seen in [0028]. Furthermore, Lambert teaches the breathing protector with a valve function in which the valve is closed by exerting finger pressure against the cover plate 8 as seen in [0034] and Fig. 9 which is similar to Persson’s teaching. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the breathing protector taught by Persson in view of Leibitzki to have a closing member made out of a hard material as taught by Lambert, as an alternative material choice that will not affect the function and/or the operation of the device.
Conclusion
THIS ACTION IS MADE FINAL. 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 Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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