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 .
Information Disclosure Statement
The information disclosure statement(s) filed on 12/28/2023 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Claims
This office action is in response to the preliminary amendment filed on 7/28/2023. As directed by the preliminary amendments, claims 1, 3-15 and 18-20 have been amended. As such, claims 1-20 are being examined in this application.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-10 and 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Conlon (US 20160015098 A1).
Regarding claim 1, Conlon teaches a filtration element (face mask 10, see Fig. 3) comprising a proximal filtration layer (first layer 33, see Fig. 3), a distal filtration layer (third layer 39, see Fig. 3) and at least one filtration layer (second layer 36, see Fig. 3) placed between the proximal filtration layer and the distal filtration layer (see Fig. 3 and [0011]), each filtration layer comprising a non-woven (NW) fabric having a filtration degree (Conlon teaches first layer 33, third layer 39 and second layer 36 to be made out of nonwoven fiber as seen in [0078] and Claim 3. Conlon further teaches a nanofiber layer coated on the outer surface 35 of first layer 33, inner and outer surfaces 37, 38 of second layer 36, and inner surface 40 of third layer 39 as seen in [0079], wherein the nanofiber media will enable high filtration as seen in [0036]-[0037]);
wherein the proximal filtration layer and the distal filtration layer have, independently, a filtration degree that is lower than the filtration degree of the at least one filtration layer placed between the proximal filtration layer and the distal filtration layer (Conlon teaches both the inner and outer surfaces 37, 38 of second layer 36 to be coated with a nanofiber layer whereas both the first layer 33 and third layer 39 is only coated on a single surface as seen in [0079]. As such, second layer 36 has a filtration degree higher than the first layer 33 and third layer 39).
Regarding claim 2, Conlon teaches the filtration element of claim 1, and further teaches comprising at least one layer that comprises a hydrophilic NW fabric (Conlon teaches the nanofiber layer to be hydrophilic as seen in [0080] and further teaches first, second and third layers 33, 36, 39 comprise material increasing in hydrophilicity as seen in [0082]).
Regarding claim 3, Conlon teaches the filtration element of claim 2, and further teaches wherein said the hydrophilic NW fabric forms part of the proximal filtration layer (Conlon teaches the nanofiber layer to be hydrophilic as seen in [0080] and further teaches a nanofiber layer coated on the outer surface 35 of first layer 33 as seen in [0079], as such a hydrophilic nanofiber forms part of first layer 33).
Regarding claim 4, Conlon teaches the filtration element of claim 2, and further teaches wherein the hydrophilic NW fabric forms part of the distal filtration layer (Conlon teaches the nanofiber layer to be hydrophilic as seen in [0080] and further teaches a nanofiber layer coated on the inner surface 40 of third layer 39 as seen in [0079], as such a hydrophilic nanofiber forms part of third layer 39).
Regarding claim 6, Conlon teaches the filtration element of claim 1, and further teaches comprising two or more filtration layers placed between the proximal filtration layer and the distal filtration layer, each having a same or different filtration degree (Conlon teaches a nanofiber layer coated on the inner and outer surfaces 37, 38 of second layer 36 between first layer 33 and third layer 39 as seen in Fig. 3 and [0079], wherein the nanofiber media will enable high filtration as seen in [0036]-[0037]).
Regarding claim 7, Conlon teaches the filtration element of claim 6, and further teaches
wherein at least one of the two or more filtration layers placed between the proximal filtration layer and the distal filtration layer comprises a hydrophilic NW fabric (Conlon teaches a nanofiber layer coated on the inner and outer surfaces 37, 38 of second layer 36 between first layer 33 and third layer 39 as seen in Fig. 3 and [0079] and further teaches the nanofiber layer to be hydrophilic as seen in [0080]).
Regarding claim 8, Conlon teaches the filtration element of claim 1, and further teaches comprising at least two hydrophilic NW fabrics, wherein at least one hydrophilic NW fabric forms or constitutes part of the proximal filtration layer and at least one other hydrophilic NW fabric forms or constitutes part of the filtration layer placed between the proximal filtration layer and the distal filtration layer (Conlon teaches the nanofiber layer to be hydrophilic as seen in [0080] and further teaches a nanofiber layer coated on the outer surface 35 of first layer 33 and inner and outer surfaces 37, 38 of second layer 36 as seen in Fig. 3 and [0079]).
Regarding claim 9, Conlon teaches the filtration element of claim 1, and further teaches wherein the proximal filtration layer, the distal filtration layer and a filtration layer placed between the proximal filtration layer and the distal filtration layer are superimposed on each other (Conlon teaches first layer 33, third layer 39 and second layer 36 placed between first layer 33 and third layer 39 are superimposed on each other as seen in Fig. 3 and [0105]).
Regarding claim 10, Conlon teaches the filtration element of claim 1, and further teaches wherein the proximal filtration layer, the distal filtration layer and a filtration layer placed between the proximal filtration layer and the distal filtration layer are fixedly attached one to another (Conlon teaches first layer 33, third layer 39 and second layer 36 placed between first layer 33 and third layer 39 wherein the layers are bound to adjacent layers as seen in Fig. 3 and [0105]).
Regarding claim 13, Conlon teaches the filtration element of claim 1, and further teaches in a form of face mask (face mask 10, see Fig. 3 and [0078]).
Regarding claim 14, Conlon teaches the filtration element of claim 1, and further teaches wherein the proximal filtration layer is configured for being in contact with a subject's skin, when worn by the subject (“…the medical facemask has a first discrete nonwoven fiber layer 33 (inner layer) disposed adjacent a wearer's face.” See [0078] and Fig. 3).
Regrading claim 15, Conlon teaches a personal protective equipment (face mask 10, see Fig. 3) comprising the filtration element (face mask 10, see Fig. 3), comprising:
a proximal filtration layer (first layer 33, see Fig. 3),
a distal filtration layer (third layer 39, see Fig. 3) and
at least one filtration layer (second layer 36, see Fig. 3) placed between the proximal filtration layer and the distal filtration layer (see Fig. 3 and [0011]), each filtration layer comprising a non-woven (NW) fabric having a filtration degree (Conlon teaches first layer 33, third layer 39 and second layer 36 to be made out of nonwoven fiber as seen in [0078] and Claim 3. Conlon further teaches a nanofiber layer coated on the outer surface 35 of first layer 33, inner and outer surfaces 37, 38 of second layer 36, and inner surface 40 of third layer 39 as seen in [0079], wherein the nanofiber media will enable high filtration as seen in [0036]-[0037]); and
wherein the proximal filtration layer and the distal filtration layer have, independently, a filtration degree that is lower than the filtration degree of the at least one filtration layer placed between the proximal filtration layer and the distal filtration layer (Conlon teaches both the inner and outer surfaces 37, 38 of second layer 36 to be coated with a nanofiber layer whereas both the first layer 33 and third layer 39 is only coated on a single surface as seen in [0079]. As such, second layer 36 has a filtration degree higher than the first layer 33 and third layer 39).
Regarding claim 16, Conlon teaches the personal protective equipment of claim 15, and further teaches being in a form of a respirator configured to be worn on a subject's face (Conlon teaches a facemask 10 which is shown as a N95 respirator worn on a user’s face as seen in Fig. 1 and 3 and [0038]).
Regarding claim 17, Conlon teaches the personal protective equipment of claim 15, and further teaches being in a form of an outfit configured to be worn on a subject's body (Figs. 3 and 4 show the facemask 10 being worn on a user’s face as an outfit (similar to the mask in applicant’s Fig. 8)).
Regarding claim 18, Conlon teaches a method for protecting a subject body (Conlon teaches a facemask that can help the user properly wear the mask and to provide potential risk of contamination to the wearer and others as seen in Fig. 3 and [0007]), the method comprising applying onto the subject's body or part thereof a filtration element (Conlon teaches using ear loops 28 and 30 attached to facemask 10 to secure the facemask to the user’s head as seen in Fig. 1 and [0047] and [0064]-[0064]) comprising a proximal filtration layer (first layer 33, see Fig. 3), a distal filtration layer (third layer 39, see Fig. 3) and at least one filtration layer (second layer 36, see Fig. 3) placed between the proximal filtration layer and the distal filtration layer (see Fig. 3 and [0011]), each filtration layer comprising a non- woven (NW) fabric having a filtration degree (Conlon teaches first layer 33, third layer 39 and second layer 36 to be made out of nonwoven fiber as seen in [0078] and Claim 3. Conlon further teaches a nanofiber layer coated on the outer surface 35 of first layer 33, inner and outer surfaces 37, 38 of second layer 36, and inner surface 40 of third layer 39 as seen in [0079], wherein the nanofiber media will enable high filtration as seen in [0036]-[0037]);
wherein the proximal filtration layer and the distal filtration layer have, independently, a filtration degree that is lower than the filtration degree of the at least one filtration layer placed between the proximal filtration layer and the distal filtration layer (Conlon teaches both the inner and outer surfaces 37, 38 of second layer 36 to be coated with a nanofiber layer whereas both the first layer 33 and third layer 39 is only coated on a single surface as seen in [0079]. As such, second layer 36 has a filtration degree higher than the first layer 33 and third layer 39).
Regarding claim 19, Conlon teaches the method of claim 18, and further teaches comprising securing the filtration element to the subject's body (Conlon teaches using ear loops 28 and 30 attached to facemask 10 to secure the facemask to the user’s head as seen in Fig. 1 and [0047] and [0064]-[0064]).
Regarding claim 20, Conlon teaches a method of producing a personal protective equipment (Conlon teaches a method of making a facemask 10 as seen in [0014]), the method comprises superimposing a proximal filtration layer (first layer 33, see Fig. 3), a distal filtration layer (third layer 39, see Fig. 3) and at least one additional filtration layer (second layer 36, see Fig. 3), placed between the proximal filtration layer and the distal filtration layer (see Fig. 3 and [0011]), each filtration layer comprising a non-woven (NW) fabric having a filtration degree (Conlon teaches first layer 33, third layer 39 and second layer 36 to be made out of nonwoven fiber as seen in [0078] and Claim 3. Conlon further teaches a nanofiber layer coated on the outer surface 35 of first layer 33, inner and outer surfaces 37, 38 of second layer 36, and inner surface 40 of third layer 39 as seen in [0079], wherein the nanofiber media will enable high filtration as seen in [0036]-[0037]);
wherein the proximal filtration layer and the distal filtration layer have, independently, a filtration degree that is lower than the filtration degree of the at least one filtration layer placed therebetween (Conlon teaches both the inner and outer surfaces 37, 38 of second layer 36 to be coated with a nanofiber layer whereas both the first layer 33 and third layer 39 is only coated on a single surface as seen in [0079]. As such, second layer 36 has a filtration degree higher than the first layer 33 and third layer 39).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conlon (US 20160015098 A1) in view of Elsberg (US 6644314 B1).
Regarding claim 5, Conlon teaches the filtration element of claim 1, but does not teach comprising a single filtration layer placed between the proximal filtration layer and the distal filtration layer.
However, Elsburg teaches “filtration composite may be a composite of multiple layers or a composite of multiple materials in a single layer (see 18).”
Conlon teaches the filtration material can be a single or multiple layer design as seen in [0040]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the filtration element taught by Conlon to have the filtration layer be a composite of multiple materials in a single layer as taught by Elsburg as a design choice to have a single filtration layer. Furthermore, Conlon teaches the nanofiber in the mask to create a gradient of multi-component material as seen in [0076]. Therefore, Conlon in view of Elsburg teaches using a single filtration layer made of multiple materials.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conlon (US 20160015098 A1) in view of Bergman (US 20190166929 A1).
Regarding claim 11, Conlon teaches the filtration element of claim 10, and further teaches first layer 33, third layer 39 and second layer 36 placed between first layer 33 and third layer 39 wherein the layers are bound to adjacent layers by methods including but not limited to adhesive bonding, thermal bonding or ultrasonic bonding as seen in Fig. 3 and [0105].
But does not teach wherein the proximal filtration layer, the distal filtration layer and the filtration layer placed between the proximal filtration layer and the distal filtration layer are fixedly attached one to another by heat welding and/or sewing.
However, Bergman teaches the proximal filtration layer (inner fabric layer 110, see Fig. 2), the distal filtration layer (outer fabric layer 120, see Fig. 2) and the filtration layer (first filter layer 1310) placed between the proximal filtration layer and the distal filtration layer (see Fig. 2) are fixedly attached one to another by heat welding and/or sewing (Bergman teaches the inner fabric layer 110, outer fabric layer 120 and first filter layer 1310 to be stacked and aligned for sewing as seen in [0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the layers of the filtration element taught by Conlon to be fixedly attached by sewing as taught by Bergman as a known alternative method of bounding adjacent layers of a mask.
Regarding claim 12, Conlon in view of Bergman teaches the filtration element of claim 11, and Bergman further teaches wherein the heat welding and/or sewing is at periphery sections of the layers (Bergman teaches using an elastic material 1210 over the edge of the layers and sewn along the edge/periphery of the layers as seen in Fig. 12B and [0054]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gaynor (US 20040000313 A1) teaches a spunbound mask where the filtration functionality of a mask is in a single, distinct layer.
Cheng (US 20090084384 A1) teaches a facemask with a hydrophilic non-woven fabric.
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