DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendments made to claims 12 and 13, the addition of new claims 21-36, and the cancellation of claims 1-11 and 16-20 in the response filed 6/27/25 are acknowledged.
Claims 12-15 and 21-36 are now pending, with claims 12-15 remaining as previously withdrawn.
Claims 21-36 are examined below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 21, 224, 26, 27, 30, 34, and 36 are objected to because of the following informalities:
“the environment” in claim 21, line 4 should be amended to recite –an environment—
“the air” in claim 21, line 17 should be amended to recite –air—
“the air” in claim 21, line 18 should be amended to recite –air—
“melting” in claim 21, line 18 should be amended to recite –configured to melt—
“absorbs” in claim 24, line 2 should be amended to recite –is configured to absorb—
“occurs” in claim 26, line 2 should be amended to recite –is configured to occur—
“melts” in claim 27, line 1 should be amended to recite –is configured to melt—
“an inner surface” in claim 30, line 3 should be amended to recite –the inner surface—
“absorbing” in claim 34, line 2 should be amended to recite –configured to absorb—
“melts” in claim 36, line 2 should be amended to recite –is configured to melt—
“solidifies” in claim 36, line 3 should be amended to recite –is configured to solidify--
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 21-36 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 21, the claim positively recites the wearer in lines 3 and 4. Language such as “configured” or “adapted” is suggested to avoid claiming a human organism.
Regarding claims 22-36, the claims are rejected under 35 U.S.C. 101 by virtue of their dependence on claim 21.
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 21-36 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 21, the claim recites the limitation “the wearer” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 22, the claim recites the limitation “the interior surface” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 23-36, the claims are rejected under 35 U.S.C. 112(b) by virtue of their dependence on claim 21.
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 pre-AIA 35 U.S.C. 103(a) 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 negated by the manner in which the invention was made.
Claim 21-23, 26, 27, 29, 31, 32, 35, and 36 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tucker et al. US 2015/0047642 A1 in view of Becker EP 0356000 A2.
Regarding claim 21, Tucker discloses a respirator 100 (fig. 4 and [0016], mask 100) comprising:
a frame 50 defining an opening, the frame 50 configured to provide structure to the respirator to allow it to retain a defined shape (fig. 4 and [0018], support structure 50 allows filter media to remain as expanded as possible, indicating that it provides structure and shape), wherein the frame 50 has an inner side facing towards the wearer and an outer side that faces away from the wearer and is exposed to the environment (fig. 4, the inner side facing filter 30 and the wearer, the outer side being the opposite side, which is exposed to the environment), the opening extending through the frame 50 between the inner and outer sides (fig. 4, the opening being the main opening in frame 50 that extends from the inner to the other side);
a filter layer 30 configured to prohibit permeation of aerosol contaminants therethrough ([0017], the filter media 30 may include a high efficiency filtering media used in the medical field, which would be capable of filtering aerosol contaminants), the filter layer 30 configured to be mounted to the frame 50 such that it covers the opening, wherein the filter layer 30 is mounted to the outer side of the frame 50 (fig. 4 [0018], filter 30 spans support structure 50 and thus covers the opening; further, since the filter media 30 is attached between the frame 50 and molded base 20 as described in [0021], filter media 30 is mounted to frame 50, including to its outer side; please note the claim does not require the filter layer to be directly mounted on the outer side);
an oronasal member 20 mounted to the inner side of the frame 50, the oronasal member 20 fluidically coupled to the opening, the oronasal member 20 including a seal contact area 24 configured to engage a facial surface of the wearer (fig. 4 and [0016], shaped molded base 20 forms a face seal 22 with a sealing edge 24 for contact with the face, and is capable of sealing around the mouth and nose; [0021], shaped molded base 20 is attached to the inner side of support structure 50 over filter media 30; the shaped molded base 20 is fluidically coupled to the opening of frame 50, as filter media allows for breathing/fluid communication between the user wearing the molded base 20 and the external environment), wherein a cavity is formed between the filter layer 30 and the seal contact area 24 within the oronasal member 20 (fig. 2 shows more clearly the cavity within the molded base 20 formed inside the protruding face seal 22, such that the cavity exists between the sealing edge 24 and the filter layer 30, which is more forward relative to the molded base 20);
a harness assembly having at least one strap coupled to at least one of the frame 50 and the oronasal member 20 (fig. 1 shows straps of a harness being connected through side apertures in frame 50; please note that according to [0021], the alternative embodiment in figs. 3 and 4 revolve around an alternate location of the filter media relative to the frame 50 and molded member 20; thus, with the same reference numbers and apertures shown in frame 50 in fig. 4, it is understood that the embodiment shown in fig. 4 can also be used with the straps shown in fig. 1).
Tucker is silent on a phase change material being incorporated into at least one of the filter layer proximate to the opening, the frame, or an inner surface of the cavity, such that the respirator is configured to allow heat from the air within the cavity to be absorbed by the phase change material to cool the air within the respirator, the phase change material melting at a predetermined temperature associated with the wearer.
However, Becker teaches an analogous respirator 2 (fig. 1 and col. 2, lines 53-54) comprising a phase change material 12 being incorporated into the filter layer 5 proximate to the opening (fig. 2 and col. 3, lines 17-32, the filter pack 5 comprises a heat sink 12 containing wax 14 having a high heat capacity that undergoes at least one phase transition; as shown in the figure, the heat sink 12 is proximate/near the opening formed in the material 4 of the hood 2), such that the respirator 2 is configured to allow heat from the air within the cavity to be absorbed by the phase change material 14 to cool the air within the respirator 2 (fig. 1, the filter pack 5 is spaced from the wearer’s face and is thus capable of allowing heat from the air circulating in the cavity of the hood 2 to be absorbed to cool the air), the phase change material 14 melting at a predetermined temperature associated with the wearer (col. 1, lines 41-46 and col. 3, lines 27-29).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the filter layer of Tucker with a phase change material incorporated into at least one of the filter layer proximate to the opening, the frame, or an inner surface of the cavity, such that the respirator is configured to allow heat from the air within the cavity to be absorbed by the phase change material to cool the air within the respirator, the phase change material melting at a predetermined temperature associated with the wearer, as taught by Becker, to prevent overheating of the air within the respirator, maintaining comfort for the user.
Regarding claim 22, Tucker in view of Becker discloses the claimed invention as discussed above.
Becker further teaches a patch or bed of phase change material 14 being bonded to the interior surface of the filter layer 5 (fig. 2 and col. 3, lines 17-32, heat sink 12 contains phase change wax inside cells 19; thus, the wax inside these cells can be considered beds of wax; further, layer 12 is fixed to the interior surface of layer 11 of the filter 5), to allow heat to be removed from inside the respirator.
Regarding claim 23, Tucker in view of Becker discloses the claimed invention as discussed above.
Becker further teaches the phase change material 14 being disposed on a component 11 that does not contact the wearer directly (fig. 2, heat sink 12 comprising PCM 14 is disposed on filter layer 11, which does not contact the wearer directly, as it is an inner layer of filter 5), to provide room in the respirator for air to circulate and be cooled.
Regarding claim 26, Tucker in view of Becker discloses the claimed invention as discussed above.
Becker further teaches a phase change of the phase change material 14 occurring at a temperature that is proximate to at least one of an exhalation air temperature of the wearer or a body temperature of the wearer (average body temperature of a human is considered to be 37 C, which falls within the phase transition temperature range of the heat sink material, as described in col. 1, lines 41-45), to allow the user to feel the cooling effects of the phase change material.
Regarding claim 27, Tucker in view of Becker discloses the claimed invention as discussed above.
Becker further teaches the phase change material 14 melting at a temperature between 30 C and 40 C (col. 1, lines 41-45, phase transition temperature can be between 20 and 100 C, which includes 30 to 40 C), to allow the user to feel the cooling effects of the phase change material, as human body temperature is typically 37 C.
Regarding claim 29, Tucker in view of Becker discloses the claimed invention as discussed above.
Becker further teaches the phase change material 14 being encapsulated by the at least one of the filter layer 5 proximate to the opening (fig. 2 and col. 3, lines 17-32, heat sink 12 contains phase change wax inside cells 19), the frame, or an inner surface of the cavity that incorporates the phase change material, to securely affix the phase change material within the respirator.
Regarding claim 31, Tucker in view of Becker discloses the claimed invention as discussed above.
Tucker further discloses the oronasal member 20 being formed of at least one of a silicone, polyisoprene, halo-butyl, and a thermoplastic elastomer ([0016], the shaped molded base 20 may be made of silicone or thermoplastic elastomer).
Regarding claim 32, Tucker in view of Becker discloses the claimed invention as discussed above.
Tucker further discloses the filter layer 30 being disposed rearward of the frame 50 (fig. 4) and at least one of leftward, rightward, and downward of the seal contact area 24 of the oronasal member 20 (fig. 4, the filter layer 30 is below/downward of the uppermost part of seal contact area 24).
Regarding claim 35, Tucker in view of Becker discloses the claimed invention as discussed above.
Tucker further discloses the respirator 100 being a half-face respirator (fig. 4, the mask capable of being worn over the mouth and nose, making it a half-face respirator).
Regarding claim 36, Tucker in view of Becker discloses the claimed invention as discussed above.
Becker further teaches at least one of: at least a first portion of the phase change material 14 melting upon absorbing heat (col. 3, lines 27-32, the wax 14 of the heat sink 12 absorbs heat and undergoes a solid-liquid phase transition); and at least a second portion of the phase change material solidifies upon releasing heat, to cool the air in the respirator, maintaining comfort for the wearer.
Claims 24, 25, 28, and 34 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tucker et al. US 2015/0047642 A1 in view of Becker EP 0356000 A2 further in view of Tucker et al. US 2015/0238725 A1 (hereinafter, “Tucker 2”).
Regarding claim 24, Tucker in view of Becker discloses the claimed invention as discussed above.
Tucker in view of Becker is silent on the phase change material being incorporated into the seal contact area of the face seal member and absorbing heat to provide cooling to the facial surface that engages the seal contact area.
However, Tucker 2 teaches an analogous face seal member 101 (fig. 1, the device 101 is in direct contact with the face), comprising phase change material 11 being incorporated into the seal contact area of the face seal member 101 (fig. 1 and [0062], where the thermal regulator/phase change material 11 is directly on the head, such that it forms the seal contact area of the device) and absorbing heat to provide cooling to the facial surface that engages the seal contact area ([0014], the thermal regulation being cooling).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the phase change material of Tucker in view of Becker to be incorporated into the seal contact area of the face seal member and absorbing heat to provide cooling to the facial surface that engages the seal contact area, as taught by Tucker 2, for “sustaining the temperature of the specific region of the head at a desired temperature” [0042], which would be beneficial to avoid extreme temperatures from developing at the contact areas of the mask with the face due to friction and body warmth.
Regarding claim 25, Tucker in view of Becker further in view Tucker 2 discloses the claimed invention as discussed above.
Tucker 2 further teaches the phase change material 11 being covered with an intermediate material that is safe to the touch but also allows thermal transfer between the facial surface of the wearer and the phase change material 11 ([0062], there may be a thermal transfer region on the inner surface between the thermal regulator 11 and the subject’s forehead/scalp (i.e., skin), indicating that the transfer region is safe to the touch but allows thermal transfer), to prevent extreme temperatures from directly contacting the user’s skin.
Regarding claim 28, Tucker in view of Becker discloses the claimed invention as discussed above.
Tucker in view of Becker is silent on the phase change material being at least one of a paraffin, a fatty acid, or a salt hydrate.
However, Tucker 2 teaches an analogous face seal member 101 (fig. 1, the device 101 is in direct contact with the face), comprising phase change material 303 being at least one of a paraffin, a fatty acid, or a salt hydrate ([0021], may be a paraffin).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the phase change material of Tucker in view of Becker to be at least one of a paraffin, a fatty acid, or a salt hydrate, as taught by Tucker 2, which is prima facie obvious due to the selection of a known material based on its suitability for its intended use (please see MPEP 2144.07, In reLeshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), "selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious"; please note the specification does not provide criticality as to the specific material of the phase change material, and thus one of ordinary skill in the art would have looked to materials typically known in the art for phase changing).
Regarding claim 34, Tucker in view of Becker discloses the claimed invention as discussed above.
Tucker in view of Becker is silent on the phase change material being incorporated into the inner surface of the cavity, the phase change material absorbing heat at least from air within the cavity to provide cooling inside the respirator.
However, Tucker 2 teaches an analogous face seal member 101 (fig. 1, the device 101 is in direct contact with the face), comprising phase change material 11 being incorporated into the contact area of a face seal member 101 (fig. 1 and [0062], where the thermal regulator/phase change material 11 is directly on the head, such that it forms the seal contact area of the device; this contact area is analogous to the inner surface of the cavity of Tucker in view of Becker, as the inner surface of the cavity would directly contact the skin of the nose and cheeks when the mask is worn) and absorbing heat at least from air within the cavity to provide cooling inside the respirator ([0014], the thermal regulation being cooling; thus, the combination of Tucker, Becker, and Tucker 2 would result in heat being absorbed from air within the cavity due to the inner surface of the cavity (i.e., the contact surface) including cooling phase change material).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the phase change material of Tucker in view of Becker to be incorporated into the inner surface of the cavity, the phase change material absorbing heat at least from air within the cavity to provide cooling inside the respirator, as taught by Tucker 2, for “sustaining the temperature of the specific region of the head at a desired temperature” [0042], which would be beneficial to avoid extreme temperatures from developing at the contact areas of the mask with the face due to friction and body warmth.
Claim 30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tucker et al. US 2015/0047642 A1 in view of Becker EP 0356000 A2 further in view of Bryant et al. US 5,366,801.
Regarding claim 30, Tucker in view of Becker discloses the claimed invention as discussed above.
Tucker in view of Becker is silent on the phase change material being microencapsulated in a polymer coating prior to being incorporated into at least one of the filter layer proximate to the opening, the frame, or an inner surface of the cavity that incorporates the phase change material.
However, Bryant teaches a fabric with phase change material (col. 1, lines 6-11) wherein the phase change material is microencapsulated in a polymer coating 10 prior to being incorporated into the analogous substrate (col. 4, lines 9-14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the phase change material incorporated into at least one of the filter layer proximate to the opening, the frame, or an inner surface of the cavity that incorporates the phase change material of Tucker in view of Becker to be microencapsulated in a polymer coating prior to being incorporated into the mask, as taught by Bryant, to add durability and enhance its life (col. 4, lines 22-24).
Claim 33 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tucker et al. US 2015/0047642 A1 in view of Becker EP 0356000 A2 further in view of Montesi US 4,630,604.
Regarding claim 33, Tucker in view of Becker discloses the claimed invention as discussed above.
Tucker in view of Becker is silent on the frame including an exhalation valve.
However, Montesi teaches an analogous mask 10 with a frame 14 (fig. 1 and col. 3, lines 42-46), the frame 14 including an exhalation valve 26 (fig. 1 and col. 4, lines 13-20, ring 22 of frame 14 supports exhalation valve 26).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the frame of Tucker in view of Becker with an exhalation valve, as taught by Montesi, to provide more controlled respiration.
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 MICHELLE J LEE whose telephone number is (571)270-7303. The examiner can normally be reached 9 AM - 5 PM.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786