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 1-9 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 “a filter material … wherein, when exhaled breath particles pass through the filter material, the following occurs: when the pathogen binding adsorptive reagent reacts, a positive test for respiratory viral pathogens is indicated by the filter material”. It is unclear how the filter material is indicated since the filter material does not react to the pathogen, rather the pathogen is reactive with the absorptive reagent. Thus, it is suggested that Applicant amend the claims to further clarify what feature is “indicated” when the pathogen reacts.
In addition, Applicant teaches a positive test is indicated by a particular color ([0024] of the Specification) when the respiratory viral pathogens reacts with the binding adsorptive reagent. However, it is unclear how this reaction produces a color. Applicant recites in [0022] that heparin-sepharose or sulfated cellulose are pathogen binding adsorptive reagent used to provide a color indicator when binding to respiratory viral pathogens ([0024-0025] of the Specification). However, heparin-sepharose are not known to change color during reaction (see Farooqui et al., “Purification of Lipases and Phospholipases by Heparin-Sepharose Chromatography”, Lipase and Phospholipase Protocols, Chap. 13, pp 133-144; 1999) as evidenced by the experiments performed on pages 138-139. The color from the experiment of Farooqui is from a dye of toluidine blue reacting with heparin sepharose, not due to reaction from/with heparin-sepharose. Thus, it is unclear how or where the color comes from based on the claimed invention.
Claims 2-9 are rejected because they inherit the indefiniteness issue of the parent claim, claim 1.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 6-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of copending Application No. 17/895,807 (citations to claims dated 08/25/2022; hereinafter ‘807) in view of Leung (US Patent 8,303,693). This is a provisional nonstatutory double patenting rejection.
With respect to claim 1, ‘807 teaches (claim 1) a rapid testing mechanism, including:
a filter material positioned to capture exhaled breath particles from a respiratory tract of a mammal (lines 2-3);
wherein at least a portion of the filter material is impregnated with a pathogen binding adsorptive reagent (lines 4-5), wherein the pathogen binding adsorptive reagent is positioned between an internal layer and an external layer of the filter material (it is noted that “filter material includes a pathogen binding adsorptive reagent” of lines 4-5 inherently includes material located between an inner most layer and outermost layer of the filter material); and
wherein, when exhaled breath particles pass through the filter material, the following occurs (lines 7-8):
when the pathogen binding adsorptive reagent reacts, a positive test for respiratory viral pathogens is indicated by the filter material (lines 9-10); and
when the pathogen binding adsorptive reagent does not react, a negative test for respiratory viral pathogens is indicated by the filter material (lines 11-13).
However, ‘807 is silent regarding the rapid testing mechanism including a transparent membrane positioned at the external layer of the filter material; and wherein the positive or negative test indication is visible to the external environment through the transparent membrane.
Leung teaches a filter material positioned to capture the flow of air including a transparent membrane (95; SARAN polyvinylidene chloride are transparent material, typically known as Saran Wrap) positioned at the external layer of the filter material (col. 9, lines 27-48; FIG. 1-2).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the transparent membrane as taught by Leung as the outer membrane for the filter material of ‘807 to protect the filter material from exposure to the surroundings (col. 9, lines 27-48; Leung).
With respect to claim 2, ‘807, as combined with Leung, teaches the rapid testing mechanism of claim 1, wherein the transparent membrane is incorporated into the external layer of the filter material (col. 9, lines 27-48; Leung).
With respect to claim 3, ‘807, as combined with Leung, teaches the rapid testing mechanism of claim 1, further including a porous sealed packet containing the pathogen binding adsorptive reagent (claim 6).
With respect to claim 6, ‘807, as combined with Leung, teaches the rapid testing mechanism of claim 1, wherein the pathogen binding adsorptive reagent is a sulfated cellulose membrane (claim 1, lines 5-6).
With respect to claim 7, ‘807, as combined with Leung, teaches the rapid testing mechanism of claim 1, wherein the transparent membrane forms an at least partially non-permeable barrier (col. 9, lines 27-48; Leung), filtering viruses from the external environment.
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/895,807 (citations to claims dated 08/25/2022; hereinafter ‘807) in view of Leung (US Patent 8,303,693), and further in view of Martin et al. (US Patent 10,905,903; hereinafter Martin). This is a provisional nonstatutory double patenting rejection.
With respect to claim 8, ‘807, as combined with Leung, teaches the rapid testing mechanism of claim 1. However, ‘807, as combined with Leung, is silent regarding the rapid test mechanism further including a cover having a closed position and an open position relative to the transparent membrane.
Martin teaches a mask including a filter material (12) and a cover (14) having a closed position and an open position (col. 4, line 56 to col. 5, line 28; FIG. 1).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the cover of Martin to the rapid testing mechanism as taught by ‘807, as combined with Leung, to release increased pressure inside the mask (col. 4, line 56 to col. 5, line 28; Martin). Thus, the combination of ‘807, as combined with Leung and Martin, would teach a cover (14; Martin) having a closed position and an open position (col. 4, line 56 to col. 5, line 28; FIG. 1; Martin) relative to the transparent membrane (95; Leung).
Claims 1, 3-5, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-7 of copending Application No. 17/500,126 (citations to claims dated 05/13/2022; hereinafter ‘126) in view of Leung (US Patent 8,303,693). This is a provisional nonstatutory double patenting rejection.
With respect to claim 1, ‘126 teaches (claim 1) a rapid testing mechanism, including:
a filter material positioned to capture exhaled breath particles from a respiratory tract of a mammal (lines 3-4);
wherein at least a portion of the filter material is impregnated with a pathogen binding adsorptive reagent (lines 5-6), wherein the pathogen binding adsorptive reagent is positioned between an internal layer and an external layer of the filter material (it is noted that “filter material is impregnated with a heparin sepharose pathogen binding adsorptive reagent” of lines 5-6 inherently includes material located between an inner most layer and outermost layer of the filter material); and
wherein, when exhaled breath particles pass through the filter material, the following occurs (lines 7-8):
when the pathogen binding adsorptive reagent reacts, a positive test for respiratory viral pathogens is indicated by the filter material (lines 9-10); and
when the pathogen binding adsorptive reagent does not react, a negative test for respiratory viral pathogens is indicated by the filter material (lines 11-12).
However, ‘126 is silent regarding the rapid testing mechanism including a transparent membrane positioned at the external layer of the filter material; and wherein the positive or negative test indication is visible to the external environment through the transparent membrane.
Leung teaches a filter material positioned to capture the flow of air including a transparent membrane (95; SARAN polyvinylidene chloride are transparent material, typically known as Saran Wrap) positioned at the external layer of the filter material (col. 9, lines 27-48; FIG. 1-2).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the transparent membrane as taught by Leung as the outer membrane for the filter material of ‘126 to protect the filter material from exposure to the surroundings (col. 9, lines 27-48; Leung).
With respect to claim 3, ‘126, as combined with Leung, teaches the rapid testing mechanism of claim 1, further including a porous sealed packet containing the pathogen binding adsorptive reagent (claim 5).
With respect to claim 4, ‘126, as combined with Leung, teaches the rapid testing mechanism of claim 3, wherein the porous sealed packet is positioned between two layers of multiple layers of the filter material (claim 6).
With respect to claim 5, ‘126, as combined with Leung, teaches the rapid testing mechanism of claim 1, wherein the pathogen binding adsorptive reagent is heparin Sepharose (claim 1, lines 5-6).
With respect to claim 9, ‘126, as combined with Leung, teaches the rapid testing mechanism of claim 1, including a method of testing for a plurality of different viruses using the rapid testing mechanism of claim 1 (claim 7).
Claim Rejections - 35 USC § 103
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 1-4, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Daniels (US Publication 2021/0321903; IDS dated 02/08/2024 USPub Cite No. 11) in view of Leung (US Patent 8,303,693).
With regards to claim 1, Daniels teaches a rapid testing mechanism, including:
a filter material (including mask/ EBC collector; FIG. 85) positioned to capture exhaled breath particles from a respiratory tract of a mammal ([0199]);
wherein at least a portion of the filter material is impregnated with a pathogen binding adsorptive reagent ([0203]), wherein the pathogen binding adsorptive reagent (located at biosensor) is positioned between an internal layer and an external layer of the filter material (Fig. 85); and
wherein, when exhaled breath particles pass through the filter material, the following occurs:
when the pathogen binding adsorptive reagent reacts, a positive test for respiratory viral pathogens is indicated by the filter material ([0203]; FIG. 149); and
when the pathogen binding adsorptive reagent does not react, a negative test for respiratory viral pathogens is indicated by the filter material ([0206]; FIG. 148).
However, Daniels is silent regarding the rapid testing mechanism including a transparent membrane positioned at the external layer of the filter material; wherein the positive or negative test indication is visible to the external environment through the transparent membrane.
Leung teaches a filter material positioned to capture the flow of air including a transparent membrane (95; SARAN polyvinylidene chloride are transparent material, typically known as Saran Wrap) positioned at the external layer of the filter material (col. 9, lines 27-48; FIG. 1-2).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the transparent membrane as taught by Leung as the outer membrane for the filter material of Daniels to protect the filter material from exposure to the surroundings (col. 9, lines 27-48; Leung).
With respect to claim 2, Daniels, as combined with Leung, teaches the rapid testing mechanism of claim 1, wherein the transparent membrane is incorporated into the external layer of the filter material (col. 9, lines 27-48; Leung).
With respect to claim 3, Daniels, as combined with Leung, teaches (citations to Daniels unless specified otherwise) the rapid testing mechanism of claim 1, further including a porous sealed packet (see biosensor) containing the pathogen binding adsorptive reagent (FIG. 85).
With respect to claim 4, Daniels, as combined with Leung, teaches (citations to Daniels unless specified otherwise) rapid testing mechanism of claim 3, wherein the porous sealed packet (see biosensor) is positioned between two layers of multiple layers of the filter material (FIG. 85 showing biosensor located within multiple layers).
With respect to claim 7, Daniels, as combined with Leung, teaches the rapid testing mechanism of claim 1, wherein the transparent membrane forms an at least partially non-permeable barrier (col. 9, lines 27-48; Leung), filtering viruses from the external environment.
With respect to claim 9, Daniels, as combined with Leung, teaches (citations to Daniels unless specified otherwise) the rapid testing mechanism of claim 1, including a method of testing for a plurality of different viruses ([0198, 0236, 0269]) using the rapid testing mechanism of claim 1.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Daniels (US Publication 2021/0321903; IDS dated 02/08/2024 USPub Cite No. 11) in view of Leung (US Patent 8,303,693), and further in view of Chen et al. (US Publication 2023/0157573; hereinafter Chen).
With respect to claim 5, Daniels, as combined with Leung, teaches the rapid testing mechanism of claim 1. However, Daniels, as combined with Leung, is silent regarding wherein the pathogen binding adsorptive reagent is heparin sepharose.
Chen teaches a method and device for analyzing organics in exhaled breath (abstract) wherein the pathogen binding adsorptive reagent is heparin Sepharose ([0056]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to replace one known type of pathogen binding adsorptive reagent such as those taught by Daniels, as combined with Leung, with another known type of pathogen binding adsorptive reagent as taught by Chen with reasonable expectation of capturing virus particles from exhaled breath ([0056]; Chen).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Daniels (US Publication 2021/0321903; IDS dated 02/08/2024 USPub Cite No. 11) in view of Leung (US Patent 8,303,693), and further in view of Guder et al. (US Publication 2017/0356899; IDS dated 02/08/2024 USPub Cite No. 3; hereinafter Guder).
With regards to claim 6, Daniels, as combined with Leung, teaches the rapid testing mechanism of claim 1. However, Daniels, as combined with Leung, is silent regarding wherein the pathogen binding adsorptive reagent is a sulfated cellulose membrane.
Guder teaches a sensor used in a mask ([0098]) comprising a pathogen binding adsorptive reagent ([0090]), which is a sulfated ([0095]) cellulose membrane ([0035, 0087]; FIG. 1, 14A-B).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to replace one known type of sensor as taught by Daniels, as combined with Leung, with another type of sensor as taught by Guder to provide a stronger signal for detection of vapor or gas of interest ([0095, 0097]; Guder).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Daniels (US Publication 2021/0321903; IDS dated 02/08/2024 USPub Cite No. 11) in view of Leung (US Patent 8,303,693), and further in view of Martin et al. (US Patent 10,905,903; hereinafter Martin).
With respect to claim 8, Daniels, as combined with Leung, teaches the rapid testing mechanism of claim 1. However, Daniels, as combined with Leung, is silent regarding the rapid test mechanism further including a cover having a closed position and an open position relative to the transparent membrane.
Martin teaches a mask including a filter material (12) and a cover (14) having a closed position and an open position (col. 4, line 56 to col. 5, line 28; FIG. 1).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the cover of Martin to the rapid testing mechanism as taught by Daniels, as combined with Leung, to release increased pressure inside the mask (col. 4, line 56 to col. 5, line 28; Martin). Thus, the combination of Daniels, as combined with Leung and Martin, would teach a cover (14; Martin) having a closed position and an open position (col. 4, line 56 to col. 5, line 28; FIG. 1; Martin) relative to the transparent membrane (95; Leung).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANG X.L NGUYEN whose telephone number is (571)272-1585. The examiner can normally be reached Monday-Friday 9AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, STEPHEN D. MEIER can be reached at (571) 272-2149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QXN/ Examiner, Art Unit 2853
/STEPHEN D MEIER/ Supervisory Patent Examiner, Art Unit 2853