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 .
DETAILED ACTION
In view of the appeal brief filed on 2/04/2026, PROSECUTION IS HEREBY REOPENED. The rejections are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785
Response to Amendment
Currently claims 55, 56, 58-60, 62-73 are pending for examination in this application.
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.
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) 55-56, 58-60, 62-64, 66-68 and 72-73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maryyanek et al. (US 4,592,350), hereinafter Maryyanek in view of Arrow-Smith et al. (WO 2016/032343 A1).
Regarding claim 55, Maryyanek discloses: A breathing mask (10) , wherein the breathing mask comprises a mask body (18), a mask bead (32), at least one strap holder (col. 4, lines 27-35), and at least one filter device (14, 16, 22), the mask bead, the at least one strap holder and the at least one filter device being connected to the mask body and/or are part of the mask body (see figure 1), wherein the breathing mask as a whole encloses a nose and mouth of a user (col. 2, lines 4-8), the mask bead partially delimiting a receiving opening for the nose and mouth of the user (see figure 6), wherein the at least one filter device comprises at least one filter receptacle (22) and at least one filter element (14), wherein the mask bead has a bearing region (region of 32 touching the user’s face) embodied as a sealing lip (cross-section of lip can be seen in figure 2) and is configured so that the breathing mask bears against facial skin around at least the nose and mouth of the user with the sealing lip during use and provides a seal in a respiratory-gas-tight manner (col. 3, lines 8-15), and wherein the filter device is at least partially replaceable (col. 2, lines 29-34) and respiratory gas can at least partially flow through it (col. 4, lines 36-42), the filter element comprising at least one filter material (14), wherein the mask bead comprises a nasal bridge region (32 at top of figure 6), a base region (32 at bottom of figure 6), two side regions (side regions shown in figure 6), a mask fitting (where 32 meets remainder of body 18), and a contact region (portion of 32 which contacts the user’s face), the nasal bridge region and the base region being spatially separated from one another by the side regions (see figure 6) and the nasal bridge region and the base region being each connected to both side regions (see figure 6).
Maryyanek does not explicitly disclose wherein a wall thickness of the mask bead is less in the nasal bridge region and base region than in the side regions, the wall thickness increasing in the base region toward the side regions, so that a transition region results which is arranged at least partially in the base region and wherein the wall thickness in the nasal bridge region and the base region at least corresponds to the wall thickness of the sealing lip.
However, Arrow-Smith teaches a patient interface (abstract; figure 17 shows the mask bead 180) wherein a wall thickness of the mask bead is less in the nasal bridge region (1042; [0198]) and base region (1040, 1048; [0195]-[0196]) than in the side regions (1046 [0210]), the wall thickness increasing in the base region toward the side regions ([0198] [0196] [0210]), so that a transition region (1048) results which is arranged at least partially in the base region (see figure 17; [0210]), wherein the wall thickness in the nasal bridge region and the base region at least corresponds to the wall thickness of the sealing lip (figure 17) [0196] [0198], forming a respiratory gas-tight seal [0039].
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Maryyanek to include a wall thickness of the mask bead is less in the nasal bridge region and base region than in the side regions, the wall thickness increasing in the base region toward the side regions, so that a transition region results which is arranged at least partially in the base region, wherein the wall thickness in the nasal bridge region and the base region at least corresponds to the wall thickness of the sealing lip forming a gas tight seal as taught by Arrow-Smith for the benefit of conforming to the anatomy of the user and thus improving comfort. [0191] [0196] [0198] [0200]
Regarding claim 56, Maryyanek further discloses wherein the mask body (18), the filter receptacle (22), and the mask bead (32) define a respiratory gas chamber (chamber within mask 10), which is essentially respiratory-gas-tight during use (col. 3, lines 8-12) and a respiratory gas flow from and/or to the mouth and nose of the user is thus exclusively possible through the filter device (flow into the mask and thus to the mouth and nose is exclusively through 24 and thus through 14, 16, 22; col. 3, lines 8-12; see figure 2).
Regarding claim 58, Maryyanek further discloses wherein the sealing lip, starting from the side regions, the nasal bridge region, and the base region, describes a curve in cross section and an edge of the sealing lip determines a size of an area of the receptacle opening (see figures 2 and 6).
Regarding claim 59, Maryyanek further wherein a wall thickness in a region of the side regions is greater than a wall thickness of the sealing lip (see figure 2).
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Regarding claim 60, Maryyanek further discloses wherein a wall thickness of the mask bead decreases continuously from the side regions to the sealing lip (see figure 2).
Regarding claim 62, Maryyanek further discloses wherein the bearing region of the mask bead has corner points (see points shown in annotated figure 6 below which are at corners), which are used for aligning the breathing mask on a face (the examiner notes this limitation is intended use), at the transitions from the nasal bridge region a to the side region and from the base region a to the side region (see figure 6 below).
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Regarding claim 63, Maryyanek further discloses wherein the sealing lip, starting from the side regions, the nasal bridge region, and the base region, protrudes in an arc into the receptacle opening of the mask bead (see figure 2).
Regarding claim 64, Maryyanek further discloses wherein the filter receptacle is formed as a surface (surface of 22), thus has a significantly greater dimension in a direction x2 and a direction y2 (forming the triangular shape as shown in figure 1) perpendicular thereto than in a direction z2 perpendicular to a plane E2 spanned by x2 and y2 (the thickness shown in figure 2).
Regarding claim 66, Maryyanek further discloses wherein the respiratory gas chamber and the filter device are at least dimensioned in such a way that it is possible to wash out CO2. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). It is the examiner’s position that Maryyanek discloses all the structural limitations and thus is capable of performing the function of CO2 wash out.
Regarding claim 67, Maryyanek further discloses wherein the filter device is arranged in such a way that an unobstructed flow between mouth/nose and filter device is enabled (see figure 6).
Regarding claim 68, Maryyanek further discloses wherein the filter receptacle defines a plane E2 (plane defined by 22) and the mask bead defines a plane E1 (plane defined by 32), wherein the mask bead is constructed mirror symmetrically (see figure 6), a mirror plane E3 extending through the base region and the nasal bridge region, but not through the side regions, and wherein the plane El intersects the mirror plane E3 and is spanned by at least two connecting lines (Li, L2), the connecting lines (L1, L2) each extending between a point (p1, p2) on an outer side of the bearing region facing toward a face of the user and an associated mirror point (p1', p2'). See annotated figure below.
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Regarding claim 72, Maryyanek discloses the claimed invention substantially as claimed as set forth for claim 68 above. Maryyanek does not explicitly disclose wherein the planes El and E2 are perpendicular or at an angle of 90 to 45 degrees to one another (see figure 2).
However, Maryyanek illustrates the planes El and E2 are perpendicular or at an angle of 90 to 45 degrees to one another (figure 2). The description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977). See MPEP 2125. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the angle between the planes to be within applicant’s claimed range as this is reasonably taught by the drawings.
Regarding claim 73, Maryyanek further discloses wherein the filter material is configured and designed to filter germs and other microorganisms out of air and/or other gases and to retain them on and/or in the filter material (col. 2, lines 29-34).
Claim(s) 55, 65 and 68-71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gurtowksi (US 3,137,296), hereinafter Gurtowski, in view of Arrow-Smith et al. (WO 2016/032343 A1).
Regarding claim 55, Gurtowski discloses: A breathing mask (figure 1) , wherein the breathing mask comprises a mask body (1), a mask bead (portion of 1 that interfaces with a user as shown in figure 6), at least one strap holder (6, 6b), and at least one filter device (2, 9, 4, 3, 10, 11, 8), the mask bead, the at least one strap holder and the at least one filter device being connected to the mask body and/or are part of the mask body (see figure 1), wherein the breathing mask as a whole encloses a nose and mouth of a user (see figure 6), the mask bead partially delimiting a receiving opening for the nose and mouth of the user (see figure 6; col. 1, lines 40-45), wherein the at least one filter device comprises at least one filter receptacle (2) and at least one filter element (9), wherein the mask bead has a bearing region (region of 1 touching the user’s face; col. 1, lines 40-45) embodied as a sealing lip (cross-section of lip can be seen in figure 2) and is configured so that the breathing mask bears against facial skin around at least the nose and mouth of the user with the sealing lip during use and provides a seal in an respiratory-gas-tight manner (col. 1, lines 40-45), and wherein the filter device is at least partially replaceable (col. 2, lines 15-20) and respiratory gas can at least partially flow through it (col. 1, lines 8-12), the filter element comprising at least one filter material (9);
wherein the mask bead comprises a nasal bridge region (1 at top of figure 6), a base region (1 at bottom of figure 6), two side regions (side regions shown in figure 6 and figures 1 and 3), a mask fitting (where 1 which interfaces the user meets remainder of body 1), and a contact region (portion of 1 which contacts the user’s face), the nasal bridge region and the base region being spatially separated from one another by the side regions (see figures, 1, 3, 6) and the nasal bridge region and the base region being each connected to both side regions (see figures 1, 3, 6).
Gurtowski does not explicitly disclose wherein a wall thickness of the mask bead is less in the nasal bridge region and base region than in the side regions, the wall thickness increasing in the base region toward the side regions, so that a transition region results which is arranged at least partially in the base region and wherein the wall thickness in the nasal bridge region and the base region at least corresponds to the wall thickness of the sealing lip.
However, Arrow-Smith teaches a patient interface (abstract; figure 17 shows the mask bead 180) wherein a wall thickness of the mask bead is less in the nasal bridge region (1042; [0198]) and base region (1040, 1048; [0195]) than in the side regions (1046 [0210]), the wall thickness increasing in the base region toward the side regions ([0198] [0195] [0210]), so that a transition region (1048) results which is arranged at least partially in the base region (see figure 17; [0210]), wherein the wall thickness in the nasal bridge region and the base region at least corresponds to the wall thickness of the sealing lip (figure 17). [0196] [0198], forming a respiratory gas-tight seal [0039].
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Maryyanek to include a wall thickness of the mask bead is less in the nasal bridge region and base region than in the side regions, the wall thickness increasing in the base region toward the side regions, so that a transition region results which is arranged at least partially in the base region, wherein the wall thickness in the nasal bridge region and the base region at least corresponds to the wall thickness of the sealing lip forming a gas tight seal as taught by Arrow-Smith for the benefit of conforming to the anatomy of the user and thus improving comfort. [0191] [0196] [0198] [0200]
Regarding claim 65, Gurtowski discloses the claimed invention substantially as claimed as set forth for claim 55 above. Gurtowksi does not explicitly disclose wherein a ratio of an area of the receptacle opening of the mask bead to an area of the filter device through which flow occurs is from 2:1 to 1:2, an area of the filter device through which respiratory gas flows being at least 16 cm2.
However, Gurtowski illustrates area of the receptacle opening of the mask bead to an area of the filter device through which flow occurs is from 2:1 to 1:2 (see figures 1 and 3). The description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977). See MPEP 2125. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify a ratio of an area of the receptacle opening of the mask bead to an area of the filter device through which flow occurs is from 2:1 to 1:2 to be within applicant’s claimed range as this is reasonably taught by the drawings.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Gurtowski to have an area of the filter device through which respiratory gas flows being at least 16 cm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Gurtowski would not operate differently with the claimed dimensions and the device would function appropriately having the claimed dimension. Further, applicant places no criticality on the range claimed.
Regarding claim 68, Gurtowski further discloses wherein the filter receptacle defines a plane E2 (plane defined by 9) and the mask bead defines a plane E1 (plane defined by periphery of 1), wherein the mask bead is constructed essentially mirror symmetrically (see figures 1 and 3), a mirror plane E3 (through 10) extending through the base region and the nasal bridge region (see figures 1 and 3), but not through the side regions (see figures 1 and 3), and wherein the plane El intersects the mirror plane E3 and is spanned by at least two connecting lines (Li, L2), the connecting lines (L1, L2) each extending between a point (p1, p2) on an outer side of the bearing region facing toward a face of the user and an associated mirror point (p1', p2'). See annotated figure below. Similar points exist in figure 1 as well.
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Regarding claim 69, Gurtowski discloses the claimed invention substantially as claimed as set forth for claim 68 above. Gurtowksi does not explicitly disclose wherein the planes El and E2 extend essentially in parallel to one another and are spaced apart from one another.
However, Gurtowski illustrates wherein the planes El and E2 extend essentially in parallel to one another and are spaced apart from one another (see figure 6 when mask is worn by user). The description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977). See MPEP 2125. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the mask of Gurtowski such that the planes El and E2 extend essentially in parallel to one another and are spaced apart from one another as this is reasonably taught by the drawings.
Regarding claim 70, Gurtowski discloses the claimed invention substantially as claimed as set forth for claim 68 above. Gurtowksi does not explicitly disclose
wherein the planes El and E2 extend perpendicular to the mirror plane E3.
However, Gurtowski illustrates (see figure 6) wherein the planes El and E2 extend perpendicular to the mirror plane E3 (defined by 10 as shown in figure 3). The description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977). See MPEP 2125. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the mask of Gurtowski such that the planes El and E2 extend essentially perpendicular to the mirror plane E3 as this is reasonably taught by the drawings.
Regarding claim 71, Gurtowski discloses the claimed invention substantially as claimed as set forth for claim 68 above. Gurtowksi does not explicitly disclose
wherein the plane El is perpendicular to the mirror plane E3 and the plane E2 is inclined at an angle of from 0 to 15 degrees in relation to the plane El and/or the mirror plane E3.
However, Gurtowski illustrates (see figure 6 and/or figure 2) wherein the plane El is perpendicular to the mirror plane E3 (defined by 10) and the plane E2 is inclined at an angle of from 0 to 15 degrees in relation to the plane El and/or the mirror plane E3 (defined by 10). The description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977). See MPEP 2125. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the mask of Gurtowski such that the planes El and E2 extend essentially perpendicular to the mirror plane E3 as this is reasonably taught by the drawings.
Response to Arguments
Applicant's arguments filed 8/03/2026 have been fully considered but they are not persuasive.
Applicant argues that Arrow-Smith does not disclose the feature the examiner concedes Maryyanek and Gurtowski lack. Applicant states [0195] states nothing about thickness. The rejection has been updated to include [0196] which states “Accordingly, the chin region 1040 can have a thinner cross-section than other regions of the seal 180. In some configurations, the chin region 1040 has the smallest thickness of the seal 180, which may be equal to a thickness of other regions. For example, a portion or an entirety of the chin region 1040 can have a thickness of about 0.3 mm. In some configurations, the thickness of the chin region 1040 can be less than 0.3 mm. For example, the thickness could be as low as about 0.15 mm.”
Applicant argues that the transition portion is not within the base region. The examiner respectfully points to figure 17 which very clearly shows the transition region (1048) in the base region and is further described in [0210]. Applicant states that the transition region is distinct from the base region and it is located in the base region. The prior art of Arrow-Smith shows this in figure 17 and is described in [0210].
Applicant argues Arrow-Smith teaches the opposite of “at least corresponds to the wall thickness of the sealing lip”. The examiner notes this limitation is very broad. Figure 17 shows that the thicknesses correspond as they are in conformity or agreement simply by being on the same mask. The examiner also makes note of [0196] which states that the chin region can be equal to other regions and that it can be 0.3mm and [0198] which states that the nose region can be 0.3mm.
Applicant states that there is no rational underpinning on record. The examiner respectfully disagrees. The examiner articulated the modification was for the benefit of conforming to the anatomy of the user and thus improving comfort. This rationale is maintained. [0198] indicates gently sealing and [0196] states that the chin region is a relatively soft region that contacts the area below the lower lip of the user and can allow the seal 180 to accommodate a range of chin geometries.
Applicant appears to argue that Maryyanek and Arrow-Smith are non-analogous art. Applicant states that Arrow-Smith is not reasonably pertinent to the problem with which the inventors were concerned. The examiner notes that applicant has not provided what they contend their “problem with which the inventors were concerned” is, but state that “seal leakage” as set forth by the examiner previously is erroneous and too general. The examiner again reiterates, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Maryyanek is in the same field of endeavor as applicant’s invention. Arrow-Smith is also a breathing mask, but is specifically drawn to a particular problem [0011] [0039] with which the inventor was concerned: mask seals that adapt to a user’s face to prevent leakage (see page 2 lines 9-12 of applicant’s disclosure). Thus the examiner maintains that Maryyanek and Arrow-Smith are analogous art. In response to applicant's argument based upon the age of the references, contentions that the reference patents are old are not impressive absent a showing that the art tried and failed to solve the same problem notwithstanding its presumed knowledge of the references. See In re Wright, 569 F.2d 1124, 193 USPQ 332 (CCPA 1977).
Applicant asserts that claim 56 and 66 are separately allowable and the prior art does not read on “from and/or to the mouth and nose of the user is thus exclusively possible through the at least one filter device”. The broadest reasonable interpretation of the limitation in question requires only “from” or “to” and thus since Maryyanek discloses into the mask and thus “to” the mouth and nose, the prior art reads on the claim.
Applicant asserts that “configured for” is a structural limitation and cannot be “intended use”. The examiner notes “configured for” language is describing a function/intended use, not a structure. The examiner maintains that Maryyanek discloses the claimed limitations. Further, it appears the prior art’s corner points are identical to applicants. Provided below is an annotated figure from applicant’s disclosure pointing to the corner points disclosed by applicant.
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Applicant asserts that Maryyanek does not disclose perpendicular planes or at an angle relative to one another. This is clearly shown in the annotated figure the examiner provided and is properly rejected relying on MPEP 2125.
Applicant asserts that Gurtowski does not disclose a mask bead having the claimed regions because mapping claim elements on to unlabeled portions of one undifferentiated molded periphery is conclusory citing to Warner. Applicant’s seal, shown below is also a single piece. It would be unreasonable to conclude that a seal does not include a nasal region, base region, lateral regions when they are clearly shown in the prior art, simply because they are not labeled.
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Regarding claim 65, applicant asserts that Gurtkowski does not disclose the claimed ratio. The examiner is not relying on the figure to show “particular sizes” but is relying on the figures to show what would be reasonably taught based on the figures which is proper under MPEP 2125. The examiner also disagrees that reliance on Gardner is misplaced. In Gardner, the differences between the prior art and the claimed invention were dimensional limitations and the court concluded that “the dimensional limitations did not specify a device which performed and operated any differently from the prior art”. The examiner maintains the rejection. Further “significance” does not equate to criticality. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
Regarding claims 69, 70 and 71 the examiner is relying on the figures to show what would be reasonably taught based on the figures which is proper under MPEP 2125.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA MURPHY whose telephone number is (571)270-7362. The examiner can normally be reached M-F 8:00am-4:00pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
