DETAILED ACTION
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the feature(s)
“a porous sealed packet containing the pathogen binding adsorptive reagent” recited in claim 4; and
“wherein the porous sealed packet is positioned between two layers of multiple layers of the filter material” recited in claims 5 and 9
must be shown or the feature(s) canceled from the claim(s). If it is important to claim a feature as being new and novel, it is also important to show the feature. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure (specification) is objected to because the following paragraphs are unclear. Particularly, it appears that the words “filter” and “filter material” are used interchangeably, so it is unclear whether they refer to the same or different thing(s). Going forward with examination, the paragraphs are interpreted to be (Note that in applicant’s response, where a change is requested in the specification, an entire paragraph of the specification containing the change will be needed):
--[0023] Typically, the filter material 14 is made up of multiple layers of material. For example, the filter material 14 may be a three-ply material including a ply of melt-blown polymer, such as polypropylene, polyethylene, or vinyl, positioned between two plies of non-woven fabric. Numerous factors, such as, for example, shape, size, thickness, number of layers, materials used, fit, breathability, filtering capabilities, disposability, etc. may all be considered, and may vary depending on the application. Additional layers may provide more filtration; however, different materials provide different filtering. Various alternatives to face masks 12 may also be used in combination with the teachings of the present disclosure.--
--[0024] The face mask 12, or an alternative, may be positioned to capture exhaled breath particles from a respiratory tract of a mammal. For example, the face mask 12 may be positioned to cover the mouth and nose of the mammal and capture breath particles in one or more layers of the filter material 14. According to an exemplary embodiment, a layer closest to the source of the exhaled breath particles may be a filter layer. Some household items may work as a filter layer in a homemade mask, including, for example, paper products that you can breathe through, such as coffee filters, paper towels, and toilet paper. As described above, various structures, materials and configurations may be incorporated into the present disclosure.--
--[0025] Knowing the average size of a virus is about 20-400 nanometers (0.02-0.04 microns), the filter material 14 may capture particles greater than about 400 nanometers (0.4 micrometers). This may allow viruses or viral particles to pass through the filter material 14. For example, the novel coronavirus is approximately 0.12 micrometers, so the novel coronavirus would pass freely through the filter material 14, but a bacteria that is 0.2 micrometers would be stopped by the filter material 14. However, most viral particles do not travel independently, but are carried by larger media, such as water droplets, that would be stopped by the filter material 14. This filtering method is provided for exemplary purposes only and other filtering methods may be used. Further, one or more of the filtering methods may be implemented to narrow the viral pathogens that are detected.--
--[0027] According to some embodiments, the filter material 14 is formed by using heparin-based porous adsorptive beads impregnated with liquid pathogen binding adsorptive reagent, then of the binding adsorptive reagent. Further, material 14 may be packaged in a porous polymeric membrane.--
--[0030] In addition to the filtering, the disclosure utilizes affinity chromatography to signify the presence of a virus or viral particles, regardless of the speciation. Non-viral material that is less than 400 nanometer may pass through the filter material 14 but will not react with the reagent. This is a low cost, highly sensitive, and qualitative test that is not labor intensive, not prone to operator variation (i.e., correct placement of nasopharyngeal swabs), or reliant on expensive, advanced technology. This technology could be available for home or commercial testing or healthcare point of care testing. The design would allow it to be deployed in resource poor countries. This test may have other novel implications, such as screening mammals (humans or animals) for the presence of contagious diseases before boarding aircraft, within closed spaces, or other places where there might be an increased risk of disease transmission, irrespective of a pandemic state. As stated above, the filter material 14 is not restricted to use with a face mask. For example, the filter material 14 may be positioned within an aircraft, classroom, office etc. to detect a presence of the virus.--
Appropriate correction is required.
Claim Objections
Claim 9 is objected to because of an administrative error. Going forward with examination, the claims are interpreted to be (and further, as discussed in the 112 rejection below):
--The standalone detection device of claim 8,
Appropriate correction is required.
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 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-20 of copending Application No. 17/895,807 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application already claim at least the following (Note that this is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented):
1. A standalone detection device for respiratory viral pathogens, including (See claims 19-20 of the reference application):
a filter material supported in a portable housing of the standalone detection device;
wherein the standalone detective device is configured and positioned for detection of proximate exhaled breath particles from a respiratory tract of a mammal without physically contacting the mammal;
wherein at least a portion of the filter material includes a pathogen binding adsorptive reagent, wherein the pathogen binding adsorptive reagent is heparin sepharose or a sulfated cellulose membrane;
wherein, when the exhaled breath particles pass through the filter material, the following occurs:
when the binding adsorptive reagent reacts, a positive test for respiratory viral pathogens is indicated by the filter material; and
when the pathogen binding adsorptive reagent does not react, a negative test for respiratory viral pathogens is indicated by the filter material.
2. The standalone detection device of claim 1, wherein the pathogen binding adsorptive reagent is heparin Sepharose (See claims 19-20 of the reference application).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 4-5 and 8-9 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. Neither the specification nor drawings clearly describes or conveys a meaning of “a porous sealed packet.”
Going forwards with examination, the claims are interpreted to be (based on the application’s specification):
--4. The standalone detection device of claim 2, wherein the filter material is packaged in a porous membrane.--
--5. The standalone detection device of claim 4, wherein includes multiple layers.
--8. The standalone detection device of claim 6, wherein the filter material includes porous adsorptive beads containing the pathogen binding adsorptive reagent.--
--9. The standalone detection device of claim 8, adsorptive beads containing the pathogen binding adsorptive reagent are positioned between two layers of the multiple layers of the filter material--
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 and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Grieve et al. (US 2013/0334042 A1; hereinafter “Grieve”).
1. Grieve teaches a standalone detection device (1) for respiratory viral pathogens (which may come from a human, an animal, etc.; Pars. 0207-0208), including (See fig. 1, reproduced below):
a filter material (8) supported in a portable housing (2/103) of the standalone detection device 1 (See, e.g., Par. 0159);
wherein the standalone detective device (1) is configured and positioned for detection of proximate exhaled breath particles from a respiratory tract of a mammal without physically contacting the mammal (See, e.g., Pars. 0207-0208);
wherein at least a portion of the filter material (8) includes a pathogen binding adsorptive reagent, the filter material (8) may be porous (Par. 0213) and include a hydrophilic gel and/or polymer to provide moisture for the pathogen to grow on the filter material 8 (Pars. 0202-0203);
wherein, when the exhaled breath particles pass through the filter material (8), the following occurs:
when the binding adsorptive reagent reacts, a positive test for respiratory viral pathogens is indicated by the filter material 8 (as the pathogens may grow on the filter material 8 and produce a chemical or biological agent leading to an electronically detectible signal; Abstract; Pars. 0005-0010); and
when the pathogen binding adsorptive reagent does not react, a negative test for respiratory viral pathogens is indicated by the filter material 8 (Abstract; Pars. 0005-0010).
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Grieve is silent about: wherein the pathogen binding adsorptive reagent is heparin sepharose or a sulfated cellulose membrane.
Grieve, as discussed above, teaches that at least a portion of the filter material (8) includes a pathogen binding adsorptive reagent, the filter material (8) may be porous and include a hydrophilic gel and/or polymer to provide moisture for the pathogen to grow on the filter material (8). Furthermore, it is known that a sulfate (e.g., sodium sulfate, or magnesium sulfate) is highly soluble in water, therefore is highly hydrophilic (See the attached online information “Sulfate vs. Sulphonate”).
Therefore, in view of Grieve teaching and the information online, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the present application to have the pathogen binding adsorptive reagent be heparin sepharose or a sulfated cellulose membrane, in order to provide moisture for the pathogen to grow on the filter material (8).
3. Grieve as modified teaches the standalone detection device of claim 2, wherein the filter material includes multiple layers 9, 11, 22 (as evident from e.g., Fig. 6, reproduced below).
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4. Grieve as modified teaches the standalone detection device of claim 2, wherein the filter material is packaged in a porous membrane (as discussed above in claim 1; Par. 0213).
5. Grieve as modified teaches the standalone detection device of claim 4, wherein the filter material includes multiple layers (as discussed above in claim 3)
6. Grieve as modified teaches the standalone detection device of claim 1, wherein the pathogen binding adsorptive reagent is sulfated cellulose membrane (as discussed above in claim 1).
7. Grieve as modified teaches the standalone detection device of claim 6, wherein the filter material includes multiple layers (as discussed above in claim 3).
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, AND if the provisional double patenting rejections were overcome. The following would be a statement for indication of an allowable subject matter:
With respect to claim 2, prior art of record doesn’t teach, suggest, or render obvious the total combination of the recited features, including the following allowable subject matter: “…wherein the pathogen binding adsorptive reagent is heparin sepharose.”
Claims 8-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims (without a need to overcome the provisional double patenting rejections). The following would be a statement for indication of an allowable subject matter:
With respect to claim 8, prior art of record doesn’t teach, suggest, or render obvious the total combination of the recited features, including the following allowable subject matter: “…wherein the filter material includes porous adsorptive beads containing the pathogen binding adsorptive reagent.”
(Claim 9 is dependent on claim 8.)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nguyen (Wyn) Q. Ha whose telephone number is (571) 272-2863, email: nguyenq.ha@uspto.gov. The examiner can normally be reached Monday - Friday 8 am - 4:30 pm (Eastern Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Stephen 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.
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/Nguyen Q. Ha/Primary Examiner, Art Unit 2853 December 30, 2025