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 .
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 1 and 5 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.
Claim 1 recites “the mask stiffener member,” which lacks proper antecedent basis.
Claim 5 recites “wherein two spaced apart filter assembles are provided, one on each of opposed lateral sides of the entire assembly” suggested to be changed to --wherein the at least one filter assembly comprises two spaced apart filter assembles [[are provided]], one of the two spaced apart filter assemblies on each of opposed lateral sides of the entire assembly-- in order to provide clarity that the two spaced apparat filter assemblies include the at least one filter assembly.
Claim 5 recites “the mask cover or face shield” however a face shield is not recited in claim 1 and therefore lacks proper antecedent basis.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2 and 4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee (2023/0356009).
Regarding claim 2, in fig. 1-7 Lee discloses a respiratory mask assembly comprising a facepiece 10 sealable [0074] in use against a wearer's face, a mask stiffener (portion of 20 that includes 47, 35 and 37, shown in fig. 3) removably (with enough force) fitted to an inwardly-facing side of the facepiece (Fig. 3-4), a mask cover (portion of 20 that includes 43 and 31, shown in fig. 3) or face shield removably (with enough force) fitted to an outwardly-facing surface of the facepiece (Fig. 1 and 3) and removably attachable to the mask stiffener (Fig 3 and 4 show that the mask cover and mask stiffener are attached to one another and are able to be removed with enough force), at least one filter assembly (41 and 45, Lee) forming an inhalation port through the assembled mask cover, the facepiece and the mask stiffener (Fig. 3-4, Lee), and an exhaust assembly (35 and 37, Lee) forming an exhalation port through the facepiece ([0083] Lee), wherein the facepiece is transparent.
Regarding claim 4, in fig. 1-7 Lee discloses a respiratory mask assembly comprising a facepiece 10 sealable [0074] in use against a wearer's face, a mask stiffener (portion of 20 that includes 47, 35 and 37, shown in fig. 3) removably (with enough force) fitted to an inwardly-facing side of the facepiece (Fig. 3-4), a mask cover (portion of 20 that includes 43 and 31, shown in fig. 3) or face shield removably (with enough force) fitted to an outwardly-facing surface of the facepiece (Fig. 1 and 3) and removably attachable to the mask stiffener (Fig 3 and 4 show that the mask cover and mask stiffener are attached to one another and are able to be removed with enough force), at least one filter assembly (41 and 45, Lee) forming an inhalation port through the assembled mask cover or face shield, the facepiece and the mask stiffener (Fig. 3-4, Lee), and an exhaust assembly (35 and 37, Lee) forming an exhalation port through the facepiece ([0083] Lee), wherein the mask cover or face shield is positioned to occlude the exhaust assembly from view (mask cover occludes the exhaust assembly, see fig. 1 and 3 of Lee).
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (2023/0356009) in view of Pathania (2023/0158345).
Regarding claim 1, in fig. 1-7 Lee discloses a respiratory mask assembly comprising a facepiece 10 sealable [0074] in use against a wearer's face, a mask stiffener (portion of 20 that includes 47, 35 and 37, shown in fig. 3) removably (with enough force) fitted to an inwardly-facing side of the facepiece (Fig. 3-4), a mask cover (portion of 20 that includes 43 and 31, shown in fig. 3) removably (with enough force) fitted to an outwardly-facing surface of the facepiece (Fig. 1 and 3) and removably attachable to the mask stiffener (Fig 3 and 4 show that the mask cover and mask stiffener are attached to one another and are able to be removed with enough force), but is silent regarding that the mask cover is interchangeable. However, in fig. 1 Pathania teaches an interchangeable mask cover (A) removably attachable to an inner mask portion (A2, see last sentence of [0089]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee’s connection between the mask cover and the mask stiffener with an interchangeable mask cover removably attachable to the mask stiffener, as taught by Pathania, for the purpose of providing replacement of the mask cover as needed. The modified Lee discloses at least one filter assembly (41 and 45, Lee) forming an inhalation port through the assembled mask cover, the facepiece and the mask stiffener member (Fig. 3-4, Lee), and an exhaust assembly (35 and 37, Lee) forming an exhalation port through the facepiece ([0083] Lee).
Regarding claim 3, in fig. 1-7 Lee discloses a respiratory mask assembly comprising a facepiece 10 sealable [0074] in use against a wearer's face, a mask stiffener (portion of 20 that includes 47, 35 and 37, shown in fig. 3) removably (with enough force) fitted to an inwardly-facing side of the facepiece (Fig. 3-4), a face shield (portion of 20 that includes 43 and 31, shown in fig. 3) removably (with enough force) fitted to an outwardly-facing surface of the facepiece (Fig. 1 and 3) and removably attachable to the mask stiffener (Fig 3 and 4 show that the mask cover and mask stiffener are attached to one another and are able to be removed with enough force), but is silent regarding that the face shield is interchangeable. However, in fig. 1 Pathania teaches an interchangeable face shield (A) removably attachable to an inner mask portion (A2, see last sentence of [0089]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee’s connection between the face shield and the mask stiffener with an interchangeable face shield removably attachable to the mask stiffener, as taught by Pathania, for the purpose of providing replacement of the face shield as needed. The modified Lee discloses at least one filter assembly (41 and 45, Lee) forming an inhalation port through the assembled face shield, facepiece and the mask stiffener (Fig. 3-4, Lee), and an exhaust assembly (35 and 37, Lee) forming an exhalation port through the facepiece ([0083] Lee).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lee and Pathania, as applied to claim 1 above, and further in view of Yates et al. (2021/0386136).
Regarding claim 5, the modified Lee discloses one filter assembly (see rejection of claim 1 above), but is silent regarding two spaced apart filter assembles provided, one on each of opposed lateral sides of the entire assembly to locate and clamp together the mask cover or face shield, the facepiece and the mask stiffener. However, in fig. 4 Yates teaches two spaced apart filter assemblies 50 provided, one on each of opposed lateral sides of the entire assembly to locate and clamp together a mask cover 20, a facepiece 10 and mask stiffeners 30 and 40 [0032]. 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 modified Lee’s connection between the mask cover, face shield and the mask stiffener with a clamping structure between the filter assemblies and mask stiffeners as well as modify the single filter assembly with two laterally opposing filter assemblies, as taught by Yates, for the purpose of providing an alternate connection of parts having the predictable results of assembling the respiratory mask assembly, as well as providing further filtration surface area to reduce of the breathing work of the user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tseng (2021/0353975), Wynalda, JR. (2017/0172137), Song et al. (2019/0388715), Metzger (2001,0050081) and Michel et al. (4,850,346) directed towards respiratory mask assemblies.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785