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 .
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 “dispersing unit” (claim 1), “conduit” (claim 1), and “collection unit” (claim 1) must be shown or the feature(s) canceled from the claim(s). 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.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a dispersing unit” in claim 1;
“a collection unit” in claim 1; and
“a measurement unit” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 1 recites “a dispersing unit”, “a collection unit”, and “a measurement unit” . The specification merely discloses the functional limitations of the dispersing unit (paragraphs [0042],[0225]), collection unit ([0042],[0226]), and measurement unit ([0042],[0048],[0227]). The specification is silent on what structures contributes to the “dispersing unit”, “collection unit”, and “measurement unit”. The figures (e.g. Fig. 1) discloses various elements, however it is unclear which elements are the claimed “dispersing unit”, “collection unit”, and “measurement unit”. Therefore, the disclosure is devoid of any structures that performs the functions in the claim and fails to clearly link the structure, material, or acts to the function. The disclosure does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention. Claims 2-15 are rejected by virtue of their dependency on claim 1.
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 1-15 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 1, claim 1 recites “the tag composition comprises two or more tags, a tag comprising a nonpathogenic portion…” in lines 2-4. It is unclear if “a tag” is further defining “two or more tags” or if the “tag composition” comprises both “two or more tags” AND “a tag comprising a nonpathogenic portion…” (i.e. three tags). For examination purposes, “a tag” is being interpreted as further defining “two or more tags”, i.e. “a tag” is interpreted as a tag of the two or more tags. Claims 2-15 are rejected by virtue of their dependency on claim 1.
Regarding claim 1, claim 1 recites “dispersed tags” in line 6. It is unclear if the “dispersed tags” of line 6 is the same or different from the “two or more tags” established in line 3. Claims 2-15 are rejected by virtue of their dependency on claim 1.
Regarding claim 1, claim 1 recites “collected tag composition” in line 8. It is unclear if the collected tag composition is the same or different from the “tag composition”. It is suggested to recite “collected tag composition” as “the tag composition”. Claims 2-15 are rejected by virtue of their dependency on claim 1.
Regarding claim 5, claim 5 recites “disperse tags” in line 2. It is unclear if the “tags” is the same or different from the “two or more tags” established in claim 1.
Regarding claim 6, claim 6 recites “concentrations” in line 4. It is unclear if “concentrations” of line 4 is the same or different from “pathogen surrogate concentrations” in line 3.
Regarding claim 10, the term “relatively highly robust” in claim 10 is a relative term which renders the claim indefinite. The term “relatively highly robust” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 11, claim 11 recites “tags” in line 1. It is unclear if the “tags” is the same or different from the “two or more tags” established in claim 1.
Regarding claim 11, claim 11 recites “tags are deployed in an aerosol form…” It is unclear if the tags are deployed by the dispersing unit of the system or if the “tags are deployed” are merely an intended use of the system, e.g. a user can deploy the tags?
Regarding claim 12, claim 12 recites “tags” in line 1. It is unclear if the “tags” is the same or different from the “two or more tags” established in claim 1. Claim 13 is rejected by virtue of its dependency on claim 12.
Regarding claim 12, claim 12 recites “tags are deployed in a solid form…” It is unclear if the tags are deployed by the dispersing unit of the system or if the “tags are deployed” are merely an intended use of the system, e.g. a user can deploy the tags? Claim 13 is rejected by virtue of its dependency on claim 12.
Regarding claim 15, claim 15 recites “tags” in line 1. It is unclear if the “tags” is the same or different from the “two or more tags” established in claim 1.
Regarding claim 1, claim limitation “a dispersing unit”, “a collection unit”, and “a measurement unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification merely discloses the functional limitations of the dispersing unit (paragraphs [0042],[0225]), collection unit ([0042],[0226]), and measurement unit ([0042],[0048],[0227]). The specification is silent on what structures contributes to the “dispersing unit”, “collection unit”, and “measurement unit”. The figures (e.g. Fig. 1) discloses various elements, however it is unclear which elements are the claimed “dispersing unit”, “collection unit”, and “measurement unit”. Therefore, the disclosure is devoid of any structures that performs the functions in the claim and fails to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
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.
(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 1-11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Molyneux et al. (US 20220341955 A1).
Regarding claim 1, Molyneux teaches a germicidal verification system (Figs. 1-6; paragraph [0021] teaches a pathogen detection system including a molecular tracer dispenser and air sampler; [0030],[0072] teaches a cleaning module to sanitize surfaces; [0130] teaches the system verifies if a pathogen level on a surface is safe; therefore, the system is capable of germicidal verification) comprising:
a dispersing unit (note that because adequate structure has not been identified in the disclosure for performing the claimed function, the 112(f) limitation is interpreted for the purpose of applying prior art as any known structure that can perform the function of dispersing a tag composition; [0027] teaches a molecular tracer dispenser 102, i.e. dispersing unit, configured to dispense or release droplets of tracer samples or barcode samples) for dispersing a tag composition (note that “tag composition” is interpreted as an intended use, see MPEP 2114; note that the “tag composition” is not positively recited structurally; [0027] teaches the molecular tracer dispenser 102 configured to dispense or release droplets of tracer samples or barcode samples from a set of tracer reservoirs; therefore, the dispenser 102 is capable of dispersing a tag composition), wherein the tag composition comprises two or more tags, a tag comprising a nonpathogenic portion having a particular range of sensitivity to exposure to ultraviolet (UV) radiation, wherein not all tags of the two or more tags have the same range of sensitivity (note that “tag composition” is interpreted as an intended use, see MPEP 2114; note that the “tag composition” and therefore “two or more tags “, “a tag comprising a nonpathogenic portion…”, and “not all tags of the two or more tags have the same range of sensitivity” is not positively recited structurally; [0027] teaches the molecular tracer dispenser 102 configured to dispense or release droplets of tracer samples or barcode samples from a set of tracer reservoirs; [0201] teaches the dispenser can be configured to dispense a tracer test load including a first modified barcode linked to UV light and a second quantity of a second modified barcode linked to a particular chemical disinfectant; therefore, the dispenser is capable of dispersing two or more tags, i.e. tracer or barcode samples, that have different UV sensitivities);
a conduit (Figs. 5A-5B and [0027],[0064] teaches a fluid outlet, i.e. conduit, for passing tracer test loads into an external environment) for providing dispersed tags in the tag composition, for being dispersed into an environment (interpreted as an intended use, see MPEP 2114; Figs. 5A-5B and [0027],[0064] teaches a fluid outlet capable of passing tracer test loads, i.e. dispersed tags, into an external environment);
a collection unit (note that because adequate structure has not been identified in the disclosure for performing the claimed function, the 112(f) limitation is interpreted for the purpose of applying prior art as any known structure that can perform the function of collecting collected tag composition; Fig. 6 and [0021], [0025],[0033] teaches air sampler 104 configured to collect bioaerosols that include tracer molecules or barcodes) for collecting collected tag composition, wherein the collected tag composition comprises portions of the dispersed tags dispersed into the environment, exposed at least in part to some UV radiation in the environment, and then collected by the collection unit (interpreted as an intended use, see MPEP 2114; Fig. 6 and [0021], [0025],[0033] teaches air sampler 104 configured to collect bioaerosols that include tracer molecules or barcodes; therefore, the air sampler is capable of collecting the tag composition that are exposed at least in part to some UV radiation; note that “UV radiation in the environment” is not a positively recited structure); and
a measurement unit (note that because adequate structure has not been identified in the disclosure for performing the claimed function, the 112(f) limitation is interpreted for the purpose of applying prior art as any known structure that can perform the function of measuring amounts of the two or more tags in the collected tag composition; [0103] teaches the system includes a fluorescence detector and computer to measure and interpret magnitude of fluorescent molecules of the air sample) for measuring amounts of the two or more tags in the collected tag composition, wherein measurements of the measurement unit of a given tag depend, at least in part, on an amount of sensitivity to UV exposure of the given tag (interpreted as an intended use, see MPEP 2114; [0103] teaches the system includes a fluorescence detector and computer to measure and interpret magnitude of fluorescent molecules of the air sample; [0037] teaches the system is configured to analyte and calculate a concentration of the barcodes; [0040] teaches the system identifies a detected tracer concentration for each tracer molecule type; [0178],[0182],[0201] teaches tracer test loads that include barcodes that are sensitive to UV-light; therefore, the fluorescence detector and computer are capable of measuring amounts of tags, that includes measuring a tag that depends on UV exposure).
Note that “tag composition…two or more tags, a tag comprising a nonpathogenic portion…”, “dispersed tags”, “an environment”, “collected tag composition”, “UV radiation in the environment”, “given tag” are not positively recited structurally and is interpreted as a functional limitation of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article “tag composition…two or more tags, a tag comprising a nonpathogenic portion…”, “dispersed tags”, “an environment”, “collected tag composition”, “UV radiation in the environment”, “given tag”) worked upon by a structure (dispersing unit, conduit, collection unit, measurement unit) being claimed does not impart patentability to the claims (see MPEP 2115).
Note that an intended use or functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended uses or functional limitations, then it meets the claim. See MPEP 2114. The apparatus of Molyneux is identical to the presently claimed structure. Molyneux discloses the claimed dispersing unit, conduit, collection unit, and measurement unit as claimed and therefore, would have the ability to perform the uses or functional limitations recited in the claim. See MPEP 2112.01 (I).
Regarding claim 2, note that “given tag” is not positively recited structurally and thus is interpreted as part of the intended uses and functional limitations of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (e.g. given tag) worked upon by a structure (e.g. dispersing unit, conduit, collection unit, and measurement unit) being claimed does not impart patentability to the claims (see MPEP 2115). The intended uses and functional limitations are given patentable weight to the extent which effects the structure of the claimed system. The prior art structure is capable of performing the intended uses and functional limitations as discussed above.
In this case, Molyneux teaches a dispersing unit ([0027] teaches a molecular tracer dispenser 102), conduit (Figs. 5A-5B and [0027],[0064] teaches a fluid outlet), collection unit (Fig. 6 and [0021], [0025],[0033] teaches air sampler 104), and measurement unit ([0103] teaches the system includes a fluorescence detector and computer) as claimed and therefore, would have the ability to perform the intended uses and functional limitations regarding the given tag, wherein sensitivity to UV exposure of the given tag is due to UV radiation degradation of the given tag. See MPEP 2112.01(I).
However, Molyneux further teaches the germicidal verification system of claim 1, wherein sensitivity to UV exposure of the given tag is due to UV radiation degradation of the given tag (note that “tag composition” and “tag” are not positively recited structurally; [0178],[0182],[0201] teaches tracer test loads that include barcodes that are sensitive to UV-light; [0182] teaches the DNA strand of the modified barcode is cut, i.e. degraded, responsive to exposure to UV light).
Regarding claim 3, note that “two or more tags” is not positively recited structurally and thus is interpreted as part of the intended uses and functional limitations of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (e.g. two or more tags) worked upon by a structure (e.g. dispersing unit, conduit, collection unit, and measurement unit) being claimed does not impart patentability to the claims (see MPEP 2115). The intended uses and functional limitations are given patentable weight to the extent which effects the structure of the claimed system. The prior art structure is capable of performing the intended uses and functional limitations as discussed above.
In this case, Molyneux teaches a dispersing unit ([0027] teaches a molecular tracer dispenser 102), conduit (Figs. 5A-5B and [0027],[0064] teaches a fluid outlet), collection unit (Fig. 6 and [0021], [0025],[0033] teaches air sampler 104), and measurement unit ([0103] teaches the system includes a fluorescence detector and computer) as claimed and therefore, would have the ability to perform the intended uses and functional limitations (i.e. dispersing, providing, collecting, measuring) regarding the two or more tags, wherein the tags of the two or more tags comprise noncoding strings of nucleic acid base pairs. See MPEP 2112.01(I).
Regarding claim 4, note that “two or more tags” and “the noncoding strings of nucleic acid base pairs” are not positively recited structurally and thus are interpreted as part of the intended uses and functional limitations of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (e.g. “two or more tags” and “the noncoding strings of nucleic acid base pairs”) worked upon by a structure (e.g. dispersing unit, conduit, collection unit, and measurement unit) being claimed does not impart patentability to the claims (see MPEP 2115). The intended uses and functional limitations are given patentable weight to the extent which effects the structure of the claimed system. The prior art structure is capable of performing the intended uses and functional limitations as discussed above.
In this case, Molyneux teaches a dispersing unit ([0027] teaches a molecular tracer dispenser 102), conduit (Figs. 5A-5B and [0027],[0064] teaches a fluid outlet), collection unit (Fig. 6 and [0021], [0025],[0033] teaches air sampler 104), and measurement unit ([0103] teaches the system includes a fluorescence detector and computer) as claimed and therefore, would have the ability to perform the intended uses and functional limitations (i.e. dispersing, providing, collecting, measuring) regarding the two or more tags, wherein the tags of the two or more tags comprise noncoding strings of nucleic acid base pairs, wherein the noncoding strings of nucleic acid base pairs are selected from the group of: DNA sequences and RNA sequences. See MPEP 2112.01(I).
Regarding claim 5, Molyneux further teaches the germicidal verification system of claim 1, wherein the conduit ([0027],[0064] teaches a fluid outlet, i.e. conduit, for passing tracer test loads into an external environment) is adapted to disperse tags into or upon air, water, and/or a material that is to be sanitized (interpreted as an intended use, see MPEP 2114; Figs. 5A-5B and [0027],[0064] teaches a fluid outlet capable of passing tracer test loads, i.e. dispersed tags, as aerosolized particles into an external environment, therefore is adapted to disperse the tags as claimed; note that “air, water, and/or a material that is to be sanitized” are note positively recited structurally).
Regarding claim 6, Molyneux further teaches the germicidal verification system of claim 1, wherein the measurements of the measurement unit measure concentrations of pathogen surrogates having differing UV sensitivities (interpreted as an intended use of the measurement unit, see MPEP 2114; note that “pathogen surrogates…” are not positively recited structurally; [0103] teaches the system includes a fluorescence detector and computer to measure and interpret magnitude of fluorescent molecules of the air sample; [0037] teaches the system is configured to analyte and calculate a concentration of the barcodes; [0040] teaches the system identifies a detected tracer concentration for each tracer molecule type; [0178],[0182],[0201] teaches tracer test loads that include barcodes that are sensitive to UV-light; [0201] teaches a first modified barcode linked to UV light, i.e. sensitive to UV light, and a second modified barcode linked to a particular chemical disinfectant, i.e. at least less sensitive or not sensitive to UV light; therefore, the fluorescence detector and computer are capable of measuring concentrations of pathogen surrogates having different UV sensitivities since the detector and computer is capable of measuring concentration of different tracer barcodes that have different UV sensitivities), whereby changes in pathogen surrogate concentrations due to UV exposure can be distinguished from changes in concentrations due to air mixing, dilution, flow obstructions, and/or introduction of non-tag materials (interpreted as an intended use of the system, see MPEP 2114; [0103] teaches the system includes a fluorescence detector and computer to measure and interpret magnitude of fluorescent molecules of the air sample; [0037] teaches the system is configured to analyte and calculate a concentration of the barcodes; [0040]-[0041] teaches the system identifies a detected tracer concentration for each tracer molecule type and monitoring changes in the tracer molecules, allowing for investigation of changes in airflow, barriers, occupancy, dilution, disinfection; [0178],[0182],[0201] teaches tracer test loads that include barcodes that are sensitive to UV-light; [0201] teaches a first modified barcode linked to UV light, i.e. sensitive to UV light, and a second modified barcode linked to a particular chemical disinfectant, i.e. at least less sensitive or not sensitive to UV light; therefore, changes in pathogen concentrations are capable of being measured to allow for distinguishing concentrations changes due to UV exposure from concentrations changes due to air mixing, dilution, flow obstructions, and/or introduction of non-tag materials).
Regarding claim 7, note that “the tag comprises a primer portion, a tag identifying sequence, and a dose-responsive sequence” is not positively recited structurally and thus is interpreted as part of the intended uses and functional limitations of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (e.g. “the tag comprises a primer portion, a tag identifying sequence, and a dose-responsive sequence”) worked upon by a structure (e.g. dispersing unit, conduit, collection unit, and measurement unit) being claimed does not impart patentability to the claims (see MPEP 2115). The intended uses and functional limitations are given patentable weight to the extent which effects the structure of the claimed system. The prior art structure is capable of performing the intended uses and functional limitations as discussed above.
In this case, Molyneux teaches a dispersing unit ([0027] teaches a molecular tracer dispenser 102), conduit (Figs. 5A-5B and [0027],[0064] teaches a fluid outlet), collection unit (Fig. 6 and [0021], [0025],[0033] teaches air sampler 104), and measurement unit ([0103] teaches the system includes a fluorescence detector and computer) as claimed and therefore, would have the ability to perform the intended uses and functional limitations (i.e. dispersing, providing, collecting, measuring) regarding the tag, wherein the tag comprises a primer portion, a tag identifying sequence, and a dose-responsive sequence. See MPEP 2112.01(I).
Regarding claim 8, note that “the tag composition comprises at least two tags that have different dose-responsive sequences” is not positively recited structurally and thus is interpreted as part of the intended uses and functional limitations of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (e.g. “the tag composition comprises at least two tags that have different dose-responsive sequences”) worked upon by a structure (e.g. dispersing unit, conduit, collection unit, and measurement unit) being claimed does not impart patentability to the claims (see MPEP 2115). The intended uses and functional limitations are given patentable weight to the extent which effects the structure of the claimed system. The prior art structure is capable of performing the intended uses and functional limitations as discussed above.
In this case, Molyneux teaches a dispersing unit ([0027] teaches a molecular tracer dispenser 102), conduit (Figs. 5A-5B and [0027],[0064] teaches a fluid outlet), collection unit (Fig. 6 and [0021], [0025],[0033] teaches air sampler 104), and measurement unit ([0103] teaches the system includes a fluorescence detector and computer) as claimed and therefore, would have the ability to perform the intended uses and functional limitations (i.e. dispersing, providing, collecting, measuring) regarding the tag composition, wherein the tag composition comprises at least two tags that have different dose-responsive sequences. See MPEP 2112.01(I).
However, Molyneux further teaches the germicidal verification system of claim 7, wherein the tag composition comprises at least two tags that have different dose-responsive sequences ([0033],[0087] teaches the barcodes have a DNA sequence; [0201] teaches a first modified barcode linked to UV light, i.e. sensitive to UV light, and a second modified barcode linked to a particular chemical disinfectant, i.e. at least less sensitive or not sensitive to UV light; therefore, the barcodes that are sensitive to UV light and sensitive to a chemical disinfectant would have different dose-responsive sequences, e.g. different UV dose-responsive sequences, in order to be responsive to desired interventions).
Regarding claim 9, note that “the tag composition comprises at least two tags that have different dose-responsive sequences” and “the different dose-responsive sequences” are not positively recited structurally and thus is interpreted as part of the intended uses and functional limitations of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (e.g. “the tag composition comprises at least two tags that have different dose-responsive sequences” and “the different dose-responsive sequences”) worked upon by a structure (e.g. dispersing unit, conduit, collection unit, and measurement unit) being claimed does not impart patentability to the claims (see MPEP 2115). The intended uses and functional limitations are given patentable weight to the extent which effects the structure of the claimed system. The prior art structure is capable of performing the intended uses and functional limitations as discussed above.
In this case, Molyneux teaches a dispersing unit ([0027] teaches a molecular tracer dispenser 102), conduit (Figs. 5A-5B and [0027],[0064] teaches a fluid outlet), collection unit (Fig. 6 and [0021], [0025],[0033] teaches air sampler 104), and measurement unit ([0103] teaches the system includes a fluorescence detector and computer) as claimed and therefore, would have the ability to perform the intended uses and functional limitations (i.e. dispersing, providing, collecting, measuring) regarding the tag composition, wherein the different dose-responsive sequences are base pair sequences selected to control for sensitivity of a tag to UV degradation. See MPEP 2112.01(I).
However, Molyneux further teaches the germicidal verification system of claim 8, wherein the different dose-responsive sequences are base pair sequences selected to control for sensitivity of a tag to UV degradation ([0033],[0087] teaches the barcodes have a DNA sequence; [0201] teaches a first modified barcode linked to UV light, i.e. sensitive to UV light, and a second modified barcode linked to a particular chemical disinfectant, i.e. at least less sensitive or not sensitive to UV light; therefore, the barcodes that are sensitive to UV light and sensitive to a chemical disinfectant would have different dose-responsive sequences, e.g. different UV dose-responsive sequences, that were selected to control sensitivity of the desired tag to UV degradation).
Regarding claim 10, note that “primer portion” (claim 7) and “the primer portion is selected to be relatively highly robust to UV exposure” (claim 10) are not positively recited structurally and thus is interpreted as part of the intended uses and functional limitations of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (e.g. “primer portion” and “the primer portion is selected to be relatively highly robust to UV exposure”) worked upon by a structure (e.g. dispersing unit, conduit, collection unit, and measurement unit) being claimed does not impart patentability to the claims (see MPEP 2115). The intended uses and functional limitations are given patentable weight to the extent which effects the structure of the claimed system. The prior art structure is capable of performing the intended uses and functional limitations as discussed above.
In this case, Molyneux teaches a dispersing unit ([0027] teaches a molecular tracer dispenser 102), conduit (Figs. 5A-5B and [0027],[0064] teaches a fluid outlet), collection unit (Fig. 6 and [0021], [0025],[0033] teaches air sampler 104), and measurement unit ([0103] teaches the system includes a fluorescence detector and computer) as claimed and therefore, would have the ability to perform the intended uses and functional limitations (i.e. dispersing, providing, collecting, measuring) regarding the primer portion, wherein the primer portion is selected to be relatively highly robust to UV exposure.. See MPEP 2112.01(I).
Regarding claim 11, Molyneux further teaches the germicidal verification system of claim 1, wherein tags are deployed in an aerosol form to be mixed with air that is to be sanitized (interpreted as an intended use, see MPEP 2114; [0064] teaches the dispenser includes a sprayer to deploy the tracer test load, or barcodes in aqueous solution, as aerosolized particles to move throughout a space; therefore, the dispenser is capable of deploying tags in aerosol form to be mixed with air that is to be sanitized at a later time; note that “tags” and “air that is to be sanitized” are not positively recited structurally).
Regarding claim 15, note that “tags” is not positively recited structurally and thus is interpreted as part of the intended uses and functional limitations of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (e.g. “tags”) worked upon by a structure (e.g. dispersing unit, conduit, collection unit, and measurement unit) being claimed does not impart patentability to the claims (see MPEP 2115). The intended uses and functional limitations are given patentable weight to the extent which effects the structure of the claimed system. The prior art structure is capable of performing the intended uses and functional limitations as discussed above.
In this case, Molyneux teaches a dispersing unit ([0027] teaches a molecular tracer dispenser 102), conduit (Figs. 5A-5B and [0027],[0064] teaches a fluid outlet), collection unit (Fig. 6 and [0021], [0025],[0033] teaches air sampler 104), and measurement unit ([0103] teaches the system includes a fluorescence detector and computer) as claimed and therefore, would have the ability to perform the intended uses and functional limitations (i.e. dispersing, providing, collecting, measuring) regarding the tags, wherein tags are selected to have robustness to UV exposure that is determined based on an amount of expected UV exposure in the environment. See MPEP 2112.01(I).
However, Molyneux further teaches the germicidal verification system of claim 1, wherein tags are selected to have robustness to UV exposure that is determined based on an amount of expected UV exposure in the environment ([0033],[0087] teaches the barcodes have a DNA sequence; [0201] teaches a first modified barcode linked to UV light, i.e. sensitive to UV light, and a second modified barcode linked to a particular chemical disinfectant, i.e. at least less sensitive or not sensitive to UV light; therefore, the barcodes that are sensitive to UV light and sensitive to a chemical disinfectant would have robustness to UV exposure, e.g. different UV dose-responsive sequences, that is determined based on an amount of expected UV exposure in the environment in order to be responsive to desired interventions).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Molyneux as applied to claim 1 above, and further in view of Zografos et al. (US 20170038353 A1).
Regarding claim 12, Molyneux fails to teach: the germicidal verification system of claim 1, wherein tags are deployed in a solid form and applied to coupons attachable to surfaces.
Zografos teaches a pathogen surrogate, formed by a DNA tag or barcode and a carrier, for use in the validation and verification of sanitation (abstract). Zografos teaches the surrogate can be introduced as an aerosol, as a suspension in a liquid spray, or on coupons that have been inoculated with known quantities of the surrogate placed at specific locations, such as areas known to be challenging for sanitization ([0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tags of Molyneux to incorporate Zografos’ teachings of pathogen surrogates introduced on coupons that have been inoculated with known quantities of the surrogate placed at specific locations ([0041]) to provide: the germicidal verification system of claim 1, wherein tags are deployed in a solid form and applied to coupons attachable to surfaces. Doing so would have a reasonable expectation of successfully improving analysis of pathogens and sanitization at specific locations that are known to be challenging for sanitization (Zografos, [0041]).
Additionally, since Zografos teaches known alternatives of tags as aerosols or coupons ([0041]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the tags of Molyneux to incorporate Zografos’ teachings of pathogen surrogates introduced on coupons that have been inoculated with known quantities of the surrogate placed at specific locations ([0041]) to provide: the germicidal verification system of claim 1, wherein tags are deployed in a solid form and applied to coupons attachable to surfaces. The result of the substitution would have been predictable, such as analysis of pathogens and sanitization at specific locations that are known to be challenging for sanitization. See MPEP 2143(I)(B).
Regarding claim 13, modified Molyneux fails to teach: the germicidal verification system of claim 12, wherein the coupons are formed from a substrate having tags attached thereto, suitable for application to a surface to be sanitized using UV radiation exposure.
Zografos teaches a pathogen surrogate, formed by a DNA tag or barcode and a carrier, for use in the validation and verification of sanitation (abstract). Zografos teaches the surrogate can be introduced as an aerosol, as a suspension in a liquid spray, or on coupons that have been inoculated with known quantities of the surrogate placed at specific locations, such as areas known to be challenging for sanitization ([0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tags of Molyneux to incorporate Zografos’ teachings of pathogen surrogates introduced on coupons that have been inoculated with known quantities of the surrogate placed at specific locations ([0041]) to provide: the germicidal verification system of claim 12, wherein the coupons are formed from a substrate having tags attached thereto, suitable for application to a surface to be sanitized using UV radiation exposure. Doing so would have a reasonable expectation of successfully improving analysis of pathogens and sanitization at specific locations that are known to be challenging for sanitization (Zografos, [0041]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Molyneux as applied to claim 1 above, and further in view of Vasefi et al. (US 20210228757 A1).
Regarding claim 14, Molyneux further teaches the germicidal verification system of claim 1, wherein the measurement unit for measuring amounts measures a first original concentration of a first tag , a second original concentration of a second tag, a first post-exposure concentration of the first tag, and a second post-exposure concentration of the second tag (interpreted as an intended use, see MPEP 2114; [0103] teaches the system includes a fluorescence detector and computer to measure and interpret magnitude of fluorescent molecules of the air sample; [0037] teaches the system is configured to analyte and calculate a concentration of the barcodes; [0040]-[0041] teaches the system identifies a detected tracer concentration for each tracer molecule type and monitoring changes in the tracer molecules; [0047] teaches air sampling and detecting presence and magnitude of materials over time; [0132]-[0133] teaches measuring changes in levels of detected barcodes in the space over time; [0141] teaches collecting an initial sample; [0178],[0182],[0201] teaches tracer test loads that include barcodes that are sensitive to UV-light; therefore, the fluorescence detector and computer are capable of measuring concentration of two tags at multiple time points, e.g. at an original concentration and at a post-exposure concentration),
wherein the first tag and the second tag have differing robustness to UV exposure ([0201] teaches a first modified barcode linked to UV light, i.e. sensitive to UV light, and a second modified barcode linked to a particular chemical disinfectant, i.e. at least less sensitive or not sensitive to UV light; therefore, the first and second tags, i.e. tracer or barcode samples, have differing robustness to UV exposure).
Molyneux fails to teach: the measurement unit for measuring amounts determines a UV germicidal effectiveness based on original versus measured concentrations of the first tag compared to original versus measured concentrations of the second tag.
Molyneux teaches the system identifies a detected tracer concentration for each tracer molecule type and monitoring changes in the tracer molecules ([0040]-[0041]). Molyneux teaches air sampling and detecting presence and magnitude of materials over time ([0047]). Molyneux teaches measuring changes in levels of detected barcodes in the space over time ([0132]-[0133]). Molyneux teaches comparing a detected pathogen curve in near real-time to a calibration period to predict current and/or future pathogen levels within this space ([0134]). Molyneux teaches the system characterizes effectiveness of intervention, such as electromagnetic disinfectants, using an unmodified tracer molecule for calibration and a known amount of modified tracer molecule or barcode that is associated with UV-light disinfectant ([0173]). Molyneux teaches the detected amounts of the barcodes allows for detection of effectiveness of an intervention type, e.g. UV light ([0174]-[0175]).
Vasefi teaches an inspection device for imaging fluorescence emission from a contaminant and configured to sanitize (abstract; [0002]). Vasefi teaches a need and desire to ensure effectiveness of a cleaning process ([0004]). Vasefi teaches analysis software also dynamically interprets measurements and calculates the duration of UV illumination required for effective disinfection for each task and also monitors the disinfection to determine if it was completed or if disinfection needs to be repeated ([0116]). Vasefi teaches the system software calculates the amount of time required to deliver sufficient disinfection energy to effectively disinfect the pathogen species of concern at the desired log reduction level ([0141]). Vasefi teaches fluorescence tags or labels can be used to bind to proteins and applied by spraying or misting ([0153]). Vasefi teaches disinfection time is dependent on the species to be disinfected or deactivated, different species different amount of UV energy; and by determining the concentration of the contamination material that may contain a pathogen the system can modify the time required so that sufficient energy is delivered to disinfect the pathogen; and the system can determine the concentration by fluorescence ([0184]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the measurement unit of Molyneux to incorporate Molyneux’s teachings of monitoring changes in levels the tracer molecules over time ([0040]-[0041],[0047],[0132]-[0133]), comparing detected pathogen in near-real time to a calibration period to predict current and future pathogen levels ([0134]), and characterizing UV-light disinfectant effectiveness based on multiple tracer molecules ([0173]-[0175]) and Vasefi’s teachings of dynamically measuring and calculation duration of UV illumination for effective disinfection ([0116],[0141]), detection of fluorescence tags ([0153]), and UV disinfection time is dependent on the species to be disinfected and amount of UV energy, wherein determining concentration by fluorescence can allow for modification of time for disinfection ([0184]) to provide: the measurement unit for measuring amounts determines a UV germicidal effectiveness based on original versus measured concentrations of the first tag compared to original versus measured concentrations of the second tag. Doing so would have a reasonable expectation of successfully improving characterization of pathogens and effectiveness of sanitation via UV over time, such as using measured concentration data before and after UV exposure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lacey et al. (US 20090023217 A1) teaches a chemical indicator device for use in detecting exposure to an oxidizing agent (abstract). Lacey teaches the chemical indicator device may be placed in an enclosed or sealed environment, such as a sterilizer, with a load of articles being processed; and the device may be monitored or observed after processing to assure that the load is exposed to the oxidizing agent and that the dose is effective for sterilization; thus, the chemical indicator device may be used to evaluate not only if the load was processed by exposure to the oxidizing agent, but also if the processing cycle achieved the appropriate effective conditions, in terms of concentration vs. time, for sterilization ([0044]).
Abad (US 20120004776 A1) teaches including introducing an inert tracer in a component; forming a fluid comprising the component; observing the concentration of the tracer in the fluid; calculating the concentration of the component in the fluid (abstract). Abad teaches more than one detection channel might be required to detect a given tracer if substantial overlap exists between the response of various tracers for a certain channel, for instance in the case of various tracers with differentiated UV absorbance profiles ([0035]).
Bower (US 20170350822 A1) teaches an apparatus including sensor elements (abstract), wherein the sensor elements have different sensitivities this can provide a detailed record about the level of exposure to a parameter ([0060]).
Mattrei (US 20210108192 A1) teaches tagging items by applying a plurality of non-coding DNA tags, wherein the selection of the particular taggants correspond to nonbinary code sequence (abstract). Mattrei teaches pathogen surrogates based on encapsulated tagged DNA for verification of sanitation ([0004]).
Hodges et al. (US 20210324485 A1) teaches airborne pathogen mobility and the airborne mobility of respiratory droplets and testing thereof, can be monitored by tracking detectable compounds and measuring concentrations (abstract). Hodges teaches a disperser (Fig. 2, computer controlled sprayer), collector (Fig. 2, sampling control), and measuring unit (Fig. 2, data processing and control system). Hodges teaches a DNA taggant ([0043]), and multiple tests can be run overlapping in time and/or space, using distinct DNA tags for pathogen simulants in tests for airflow that might overlap in time and/or space ([0053]), wherein the DNA taggant might comprise a noncoding short segment of DNA ([0055]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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