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 .
Claims Status
Claims 1-7 and 11-22 are pending and are examined.
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 1-7, 11-15, and 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,597,980 to Molyneux.. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are the same with broader terms for some structural elements. In one example, charging element is substituted for charging electrode.
Regarding Claim 1, the claims of Molyneux recite a system comprising: an air sampler comprising: a housing defining an inlet and an outlet; a flow path extending between the inlet and the outlet within the housing; a charging element arranged within the flow path proximal the inlet; a receptacle arranged within the housing, proximal the outlet, and comprising a cartridge terminal; and a power supply configured to drive a voltage between the charging element and the cartridge terminal to generate an electric field within the flow path and charge bioaerosols in air flowing through the flow path; and a replaceable cartridge comprising: a substrate; a collection surface arranged on the substrate and configured to attract charged bioaerosols moving through the flow path onto a surface of the collection surface; and an electrical connector configured to transiently engage the receptacle to locate the substrate and the collection surface within the flow path and electrically couple the collection surface to the cartridge terminal (See claim 1 of ‘980).
Regarding Claim 2, Molyneux recites the system of Claim 1, wherein the air sampler is configured to: ingest a stream of ambient air from an external environment containing the air sampler through the inlet of the flow path; and cooperate with the replaceable cartridge to collect a pathogen sample comprising charged bioaerosols extracted from the stream of ambient air on the collection surface for detection of a set of pathogens in the pathogen sample (see claim 2 of ‘980).
Regarding Claim 3, Molyneux recites the system of Claim 1, wherein the replaceable cartridge comprises a set of sensors configured to signal presence of a set of pathogens in a pathogen sample comprising charged bioaerosols collected on the collection surface; and wherein the air sampler further comprises a controller configured to: read a set of signals from the set of sensors; and interpret presence of the of the set of pathogens in air flowing through the flow path based on the set of signals (see claim 3 of ‘980).
Regarding Claim 4, Molyneux recites the system of Claim 3, wherein the replaceable cartridge further comprises a reservoir containing a volume of a hydrophobic fluid and configured to periodically release a metered volume of the hydrophobic fluid onto the collection surface; and wherein the set of sensors comprises a set of biosensors, each biosensor in the set of biosensors: fluidly coupled to the collection surface; configured to receive a fluid aliquot of the pathogen sample from the collection surface; configured to generate a signal, in the set of signals, representing presence of a particular pathogen in the set of pathogens (see claim 4 of ‘980).
Regarding Claim 5, Molyneux recites the system of Claim 3, wherein the set of sensors comprises: a first sensor configured to detect presence of a first pathogen, in the set of pathogens, in the pathogen sample; and a second sensor configured to detect presence of a second pathogen, in the set of pathogens, in the pathogen sample (see claim 5 of ‘980).
Regarding Claim 6, Molyneux recites the system of Claim 1, wherein the substrate comprises a printed circuit board comprising a set of traces integrated into the printed circuit board; wherein the collection surface is arranged on the printed circuit board and comprises a conductive surface configured to collect charged bioaerosols in air flowing through the flow path; and wherein the electrical connector is configured to transiently engage the receptacle to electrically couple the collection surface to the cartridge terminal via a first trace, in the set of traces, extending between the electrical connector and the collection surface (claim 6 of ‘980).
Regarding Claim 7, Molyneux recites the system of Claim 6, wherein the replaceable cartridge comprises a second collection surface arranged on the printed circuit board; and wherein the electrical connector is configured to transiently engage the receptacle to: electrically couple the collection surface to the cartridge terminal via the first trace; and electrically couple the second collection surface to the cartridge terminal via a second trace, in the set of traces, extending between the electrical connector and the second collection surface (see claim 7 of ‘980).
Regarding Claim 11, Molyneux recites the system of Claim 1, further comprising a second replaceable cartridge comprising: a second substrate; a second collection surface arranged on the second substrate and configured to collect charged bioaerosols moving through the flow path; and a second electrical connector configured to transiently engage the receptacle to locate the second substrate and the second collection surface within the flow path and electrically couple the second collection surface to the cartridge terminal; wherein the housing defines an opening arranged proximal the cartridge terminal; and wherein the air sampler is configured to: receive the replaceable cartridge, via the opening, within the receptacle for collection of a first pathogen sample on the collection surface during a first sampling period; and receive the second replaceable cartridge, via the opening, in replacement of the replaceable cartridge, within the receptacle for collection of a second pathogen sample during a second sampling period succeeding the first sampling period (see claim 11 of ‘980).
Regarding Claim 12, Molyneux recites the system of Claim 1, further comprising a cleaning module configured to sanitize surfaces of the air sampler between sampling periods to prevent sample contamination (see claim 12 of ‘980).
Regarding Claim 13, Molyneux recites a system comprising: an air sampler comprising: a housing defining an inlet and an outlet; a flow path extending between the inlet and the outlet within the housing; a set of charging elements arranged within the flow path proximal the inlet; a receptacle arranged proximal the outlet and comprising a cartridge terminal; and a power supply configured to drive a voltage between the set of charging elements and the cartridge terminal; and a replaceable cartridge comprising: a substrate; a set of collection surfaces arranged on the substrate, each collection surface, in the set of collection surfaces, configured to collect pathogen samples of charged bioaerosols moving through the flow path; an electrical connector configured to transiently engage the receptacle to locate the substrate within the flow path and electrically couple the set of collection surfaces to the cartridge terminal; and a set of sensors configured to generate a set of signals representing presence of a set of pathogens in pathogen samples collected on the set of collection surfaces; and a controller configured to interpret presence of the set of pathogens in air flowing through the flow path based on the set of signals (see claim 13 of ‘980).
Regarding Claim 14, Molyneux recites the system of Claim 13, wherein the set of collection surfaces comprises a first collection surface and a second collection surface; and wherein the controller is configured to: during a first sampling period, trigger electrical coupling of the cartridge terminal to the first collection surface to activate the first collection surface for collection of a first pathogen sample on the first collection surface; and during a second sampling period succeeding the first sampling period, trigger electrical coupling of the cartridge terminal to the second collection surface to activate the second collection surface for collection of a second pathogen sample on the second collection surface (see claim 14 of ‘980).
Regarding Claim 15, Molyneux recites the system of Claim 13, wherein the set of collection surfaces comprises: a first collection surface configured to collect a first pathogen sample during a first sampling period for detection of a first pathogen in the set of pathogens; and a second collection surface configured to collect a second pathogen sample during the first sampling period for detection of a second pathogen in the set of pathogens; and. wherein the set of sensors comprises: a first sensor configured to detect presence of the first pathogen and generate a first signal, in the set of signals, representing presence of the first pathogen; and a second sensor configured to detect presence of the second pathogen and generate a second signal, in the set of signals, representing presence of the second pathogen (see claim 15 of ‘980).
Regarding Claim 18, Molyneux recites the system of Claim 13, wherein the air sampler further includes: genetic material load detector arranged in the flow path and configured to detect presence of organic matter in air flowing through the flow path; and genetic sequencer configured to receive pathogen samples from the set of collection surfaces to detect presence of the set of pathogens in pathogen samples collected on the of collection surfaces (see claim 18 of ‘980).
Regarding Claim 19, Molyneux recites a system comprising: an air sampler comprising: a housing defining an inlet and an outlet; a flow path extending between the inlet and the outlet within the housing; a set of charging elements arranged within the flow path proximal the inlet; a receptacle arranged proximal the outlet and comprising a cartridge terminal; and a power supply configured to drive a voltage between the set of charging elements and the cartridge terminal; a first replaceable cartridge configured to transiently couple to the air sampler during a first sampling period and comprising: a first substrate; a first collection surface arranged on the first substrate and configured to attract charged bioaerosols, moving through the flow path, onto a surface of the first collection surface to collect a first pathogen sample during the first sampling period; a first electrical connector configured to transiently engage the receptacle to locate the first substrate within the flow path and electrically couple the first collection surface to the cartridge terminal; and a first sensor configured to generate a first signal representing presence of a first set of pathogens in the first pathogen sample; and a second replaceable cartridge configured to transiently couple to the air sampler during a second sampling period, distinct from the first sampling period, and comprising: a second substrate; a second collection surface arranged on the second substrate and configured to attract charged bioaerosols, moving through the flow path, onto a surface of the second collection surface to collect a second pathogen sample during the second sampling period; o a second electrical connector configured to transiently engage the receptacle to locate the second substrate within the flow path and electrically couple the second collection surface to the cartridge terminal; and a second sensor configured to generate a second signal representing presence of a second set of pathogens in the second pathogen sample (see claim 19 of ‘980).
Regarding Claim 20, Molyneux recites the system of Claim 19, further comprising a controller configured to: based on the first signal, interpret presence of each pathogen, in the first set of pathogens, in air flowing through the flow path during the first sampling period; and " based on the second signal, interpret presence of each pathogen, in the second set of pathogens, in air flowing through the flow path during the second sampling period (see claim 20 of ‘980).
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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (US Pub 2007/0116607).
Regarding Claim 1, Wang teaches a system comprising: an air sampler comprising: a housing defining an inlet and an outlet; a flow path extending between the inlet and the outlet within the housing; a charging element arranged within the flow path; a receptacle arranged within the housing, and comprising a cartridge terminal; and a power supply configured to drive a voltage between the charging element and the terminal to charge aerosols in air flowing through the flow path; and a collection module comprising: a collection surface configured to attract charged aerosols moving though the flow path, a coupling element configured to transiently engage the receptacle and electrically couple the collection surface to the terminal (See Fig. 11, [0002], [0441], [0104], [0240])
Regarding Claim 2, Wang teaches the system of Claim 1, wherein the air sampler is configured to: ingest a stream of ambient air from an external environment containing the air sampler through the inlet of the flow path; and cooperate with the replaceable cartridge to collect a pathogen sample comprising charged bioaerosols extracted from the stream of ambient air on the collection surface for detection of a set of pathogens in the pathogen sample ([0154], [0185], see Fig. 11)).
Claims 1, 2, 21 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mainelis (US Pub 2019/0039076).
Regarding Claim 1, Mainelis teaches a pathogen detection system (A personal electrostatic bioaerosol sampler (PEBS) for collecting bioaerosols (from virus to pollen) at high sampling flow rates and for measuring personal exposures to bioaerosols in various occupational environments. See Abstract.) comprising:
an air sampler (Fig. 2; [0063]) comprising:
a housing defining an inlet and an outlet (see top and bottom of tube in Fig. 2, inlet and outlet are on opposite ends)
a flow path extending between the inlet and the outlet within the housing (Fig. 2 tube extends like flow path between inlet and outlet);
a charging element arranged within the flow path ([0017] In certain embodiments, each half-cylinder collection chamber has a round top quarter-cylinder section in which a ground electrode is slidably inserted through a groove in a middle of the collection chamber. Fig. 2 Stainless steel wire electrode 28)
a receptacle arranged proximal the outlet within the housing and comprising a terminal ([0063] The two sections (the charging section 12 and collection section 14) in the PEBS are connected);
a power supply configured to drive a voltage between the charging element and the terminal to charge aerosols in air flowing through the flow path; and
a collection module (collector 14) comprising:
a collection surface configured to attract charged aerosols moving through the flow path;
a coupling element configured to transiently engage the receptacle and electrically couple the collection surface to the terminal ([0063] The two sections (the charging section 12 and collection section 14) in the PEBS are connected. FIG. 3 is a schematic 3D rendering of an exemplary embodiment of the PEBS 10 (FIG. 2). For the charger 12, a novel wire-to-wire concept (FIG. 1) is applied.)
Regarding Claim 2, Mainelis teaches the pathogen detection system of Claim 1, wherein the air sampler is configured to:
ingest a stream of ambient air from an external environment containing the air sampler through the inlet of the flow path ([0034] The method further includes: drawing a plurality of incoming particles of variable sizes through an inlet of the charging section); and 54 of 64PPPY-M04-U S
cooperate with the collection module to collect an air sample comprising charged aerosols extracted from the stream of ambient air on the collection surface for detection of a set of pathogens in the pathogen sample ([0034] producing a plurality of ions in the charging section such that a first member is disposed inside a center of the charging section and is configured to be connected to positive or negative high voltage and a second member is disposed therearound a midpoint of the first member inside the charging section and is configured to be grounded for charging the plurality of incoming particles; analyzing the collected particles from the sampler.)
Regarding Claim 21, Mainelis teaches the method of Claim 1, wherein the collection module comprises a first replaceable cartridge comprising the coupling element configured to transiently engage the receptacle and electrically couple the collection surface to the terminal during a first time period; and " further comprising a second replaceable cartridge comprising: a second collection surface configured to attract charged aerosols moving through the flow path; and a second coupling element configured to transiently engage the receptacle and electrically couple the collection surface to the terminal during a second time period offset the first time period (see teachings of claim 1 of Mainelis).
Regarding Claim 22, Mainelis teaches the method of Claim 1, wherein the collection module comprises a substrate; wherein the collection surface is supported by the substrate; and" wherein the coupling element is configured to transiently engage the receptacle to locate the substrate and the collection surface within the flow path (see teachings of claim 1 of Mainelis).
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.
Claims 3, 4, 5, 6, 7, 12, 15, 18, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Mainelis (US Pub 2019/0039076), in view of Relle (US Pub 2008/0281528).
Regarding Claim 3, Mainelis teaches the pathogen detection system of Claim 1 and teaches [0238] FIG. 11 an internal sensor-supported bioaerosol sample collector 1106 on the end of the micropipe 1102.
Mainelis is silent to the collection module comprises a set of sensors configured to signal presence of aerosol particles in an air sample comprising charged aerosols collected on the collection surface; and wherein the air sampler further comprises a controller configured to: read a set of signals from the set of sensors; and interpret presence of the of the aerosol particles in air flowing through the flow path based on the set of signals.
Relle teaches in the related art of an environmental sampling system. [0153] Referring now to FIG. 9B, the sample data log 200' may includes data entries for a plurality of particle counters 60.sup.1, 60.sup.2, . . . 60.sup.x, a plurality of air speed detectors 70.sup.1, 70.sup.2, . . . 70.sup.x, a plurality of humidity sensors 90.sup.1, 90.sup.2, . . . 90.sup.x, a plurality of temper sensors 95.sup.1, 95.sup.2, . . . , 95.sup.x and pressure differential detectors 80.sup.1, 80.sup.2, . . . 80.sup.x. The multiple entries may come from different systems 10A, 10B, 10C, 10D or multiple sensors attached to a single system 10. See Claim 1, means for controlling the suctioning means during a sampling period and writing the computer readable information related to the sampled plurality of environmental physical parameters to the capturing and storing means. See Claim 25, means for automatically controlling the sensing means for sampling the air at a predetermined rate of air flow on continuous run or to sample at predetermined on-off intervals, for a set amount of time to develop sample data from said sensing means; means for logging and storing in real time the sample data; and, means for collecting and loading biological contamination of suctioned sampled air, under control of the controlling means, having the logging means affixed thereto. See Claim 27, one of the controlling means is a master controller and one of the logging means includes the sample data of all the plurality of linked environmental sampling systems.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added sensors with a controller, as taught by Relle, to the collection module in the device of Manelis, for sensing multiple analytes simultaneously.
Regarding Claim 4, modified Mainelis teaches the pathogen detection system of Claim 3, wherein the collection module further comprises a reservoir (Fig. 11, reservoir 1112) configured to periodically release a metered volume of a hydrophobic fluid onto the collection surface (reservoir would be capable of releasing volume of a fluid onto the collection surface. The examiner notes that the hydrophobic fluid is directed to intended use of the device); and wherein the set of sensors comprises a set of biosensors, each biosensor in the set of biosensors: fluidly coupled to the collection surface; configured to receive a fluid aliquot of the pathogen sample from the collection surface; and configured to generate a signal, in the set of signals, representing presence of a particular pathogen in the set of pathogens (for the sensors, see teachings of Relle. Relle teaches [0153] plurality of particle counters 60.sup.1, 60.sup.2, . . . 60.sup.x, a plurality of air speed detectors 70.sup.1, 70.sup.2, . . . 70.sup.x, a plurality of humidity sensors 90.sup.1, 90.sup.2, . . . 90.sup.x, a plurality of temper sensors 95.sup.1, 95.sup.2, . . . , 95.sup.x and pressure differential detectors 80.sup.1, 80.sup.2, . . . 80.sup.x. The multiple entries may come from different systems 10A, 10B, 10C, 10D or multiple sensors attached to a single system 10. Particle counters or pressure differential detectors would be capable of detecting the presence of a second pathogen based on size or another different characteristic than the first pathogen).
Regarding Claim 5, modified Mainelis teaches the pathogen detection system of Claim 3, wherein the set of sensors comprises: a first sensor configured to detect presence of a first pathogen, in the set of pathogens, in the pathogen sample (Mainelis teaches [0238] FIG. 11 an internal sensor-supported bioaerosol sample collector 1106 on the end of the micropipe 1102.); and a second sensor configured to detect presence of a second pathogen, in the set of pathogens, in the pathogen sample (see teachings of Relle. Relle teaches [0153] plurality of particle counters 60.sup.1, 60.sup.2, . . . 60.sup.x, a plurality of air speed detectors 70.sup.1, 70.sup.2, . . . 70.sup.x, a plurality of humidity sensors 90.sup.1, 90.sup.2, . . . 90.sup.x, a plurality of temper sensors 95.sup.1, 95.sup.2, . . . , 95.sup.x and pressure differential detectors 80.sup.1, 80.sup.2, . . . 80.sup.x. The multiple entries may come from different systems 10A, 10B, 10C, 10D or multiple sensors attached to a single system 10. Particle counters or pressure differential detectors would be capable of detecting the presence of a second pathogen based on size or another different characteristic than the first pathogen).
Regarding Claims 6 and 7, Mainelis teaches the pathogen detection system of Claim 1.
Mainelis is silent to the substrate comprises the collection surface is arranged on a printed circuit board and comprises a conductive surface configured to collect charged bioaerosols in air flowing through the flow path; and wherein the connector is configured to transiently engage the collection module receptacle to electrically couple the collection surface to the collection module terminal via a first trace, in the set of traces, extending between the connector and the collection surface and the collection module comprises a second collection surface arranged on the printed circuit board; " wherein the connector is configured to transiently engage the collection module receptacle to: o electrically couple the collection surface to the collection module terminal via the first trace; and 56 of 64PPPY-M04-U S o electrically couple the second collection surface to the collection module terminal via a second trace, in the set of traces, extending between the connector and the second collection surface; and further comprising a controller configured to selectively activate collection surfaces on the printed circuit board via the set of traces.
Relle teaches in the related art of an environmental sampling system. [0116] As shown in FIGS. 1A, 1B, and 5, the air speed detector 70 receives power and communicates with the vacuum pump and system control assembly 20. The air speed detector 70 produces a standard variable signal that is interfaced such as via an A/D converter to the microprocessor 152 on the main printed circuit board PCB1. [0124] Referring also to FIGS. 2, 7 and 8, the vacuum pump and system control assembly 20 further includes a wireless communication module 175 or zigbee (e.g., Maxstream XBee) for communicating with accessories, other environmental sampling systems 10B, 10C, 10D (with one acting as the master and the others functioning as slaves, FIG. 11B) and control circuitry 40 integrated in the main printed circuit board PCB-1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the substrate in the device of Mainelis with a printed circuit board, as taught by Relle, to electrically couple the plate to the collection module, to allow for integrated circuitry, as taught by Relle, in [0124].
Regarding Claim 12, modified Mainelis teaches the pathogen detection system of Claim 1: further comprising a second cartridge comprising: a second substrate; a second collection surface arranged on the second substrate and configured to collect charged bioaerosols moving through the flow path; and a second connector configured to transiently engage the receptacle to locate the second substrate and the second collection surface within the flow path and electrically couple the second collection surface to the cartridge terminal; and wherein the air sampler is configured to: receive the collection module within the receptacle for collection of a first pathogen sample on the collection surface during a first sampling period; and 59 of 64PPPY-M04-U Sreceive the second cartridge, in replacement of the collection module, within the receptacle for collection of a second pathogen sample during a second sampling period succeeding the first sampling period (see teaching of Mainelis in view of Relle regarding collection surfaces).
Regarding Claim 15, Mainelis teaches a pathogen detection system (A personal electrostatic bioaerosol sampler (PEBS) for collecting bioaerosols (from virus to pollen) at high sampling flow rates and for measuring personal exposures to bioaerosols in various occupational environments. See Abstract.) comprising:
an air sampler (Fig. 2; [0063]) comprising:
a housing (see top and bottom of tube in Fig. 2, inlet and outlet are on opposite ends);
a flow path within the housing defining an inlet and an outlet (Fig. 2 tube extends like flow path between inlet and outlet);
a set of charging elements arranged within the flow path proximal the inlet (([0017] In certain embodiments, each half-cylinder collection chamber has a round top quarter-cylinder section in which a ground electrode is slidably inserted through a groove in a middle of the collection chamber. Fig. 2 Stainless steel wire electrode 28. See also charging sections.)
a receptacle arranged proximal the outlet and comprising a cartridge terminal ([0063] The two sections (the charging section 12 and collection section 14) in the PEBS are connected); and60 of 64PPPY-M04-U S
a power supply configured to drive a voltage between the set of charging elements and the cartridge terminal ([0104] (2) operates by plug-in power and/or battery); and
a collection module (collector 14) comprising:
a substrate ([0064] The collection section 14 consists of two half-cylinder collection chambers 36 divided by the thin metal collection plate 38);
a set of collection surfaces arranged on the substrate, each collection surface, in the set of collection surfaces, configured to collect pathogen samples of charged bioaerosols moving through the flow path (collection plate 38);
a connector configured to transiently engage the receptacle to locate the substrate within the flow path and electrically couple the set of collection surfaces to the cartridge terminal (the charging section 12 and collection section 14) in the PEBS are connected. FIG. 3 is a schematic 3D rendering of an exemplary embodiment of the PEBS 10 (FIG. 2). For the charger 12, a novel wire-to-wire concept (FIG. 1) is applied.); and
Mainelis is silent to a set of sensors configured to generate a set of signals representing presence of a set of pathogens in pathogen samples collected on the set of collection surfaces; and a controller configured to interpret presence of a set of pathogens in air flowing through the flow path based on the set of signals.
Relle teaches in the related art of an environmental sampling system. [0153] Referring now to FIG. 9B, the sample data log 200' may includes data entries for a plurality of particle counters 60.sup.1, 60.sup.2, . . . 60.sup.x, a plurality of air speed detectors 70.sup.1, 70.sup.2, . . . 70.sup.x, a plurality of humidity sensors 90.sup.1, 90.sup.2, . . . 90.sup.x, a plurality of temper sensors 95.sup.1, 95.sup.2, . . . , 95.sup.x and pressure differential detectors 80.sup.1, 80.sup.2, . . . 80.sup.x. The multiple entries may come from different systems 10A, 10B, 10C, 10D or multiple sensors attached to a single system 10. See Claim 1, means for controlling the suctioning means during a sampling period and writing the computer readable information related to the sampled plurality of environmental physical parameters to the capturing and storing means. See Claim 25, means for automatically controlling the sensing means for sampling the air at a predetermined rate of air flow on continuous run or to sample at predetermined on-off intervals, for a set amount of time to develop sample data from said sensing means; means for logging and storing in real time the sample data; and, means for collecting and loading biological contamination of suctioned sampled air, under control of the controlling means, having the logging means affixed thereto. See Claim 27, one of the controlling means is a master controller and one of the logging means includes the sample data of all the plurality of linked environmental sampling systems.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added sensors with a controller, as taught by Relle, to the collection module in the device of Mainelis, for sensing multiple analytes simultaneously.
Regarding Claim 18, modified Manelis teaches the pathogen detection system of Claim 15: wherein the cartridge further comprises a fluid reservoir preloaded with a volume of fluid and fluidly coupled to the set of collection surfaces; wherein the set of sensors comprises a set of biosensors, each biosensor, in the set of biosensors: arranged on a collection surface in the set of collection surfaces; and configured to generate a signal, in the set of signals, representing presence of a particular pathogen, in the set of pathogens, in fluid contacting the biosensor; and 62 of 64PPPY-M04-U S wherein the controller is configured to interpret presence of the set of pathogens in air flowing through the flow path based on the set of signals generated by the set of biosensors (see teachings of Manelis and Relle in claim 15 reservoir, sensors, and interpreting pathogens. Relle teaches regarding [0160], [0161], [0164]) The method includes collecting by the environmental sampling/sensor probe assembly 50 environmental samples. [0095] 32 sensors or detectors. [0136] sensors are connected such as particle counter 60, air speed detector 70, pressure differential detector 80, humidity sensor 90, and temperature sensor 95).
Regarding Claim 25, modified Mainelis teaches the system of Claim 15, wherein the first collection surface is configured to collect the first aerosol sample for detection of aerosols of the first aerosol type comprising a first pathogen; wherein the second collection surface is configured to collect the second aerosol sample for detection of aerosols of the second aerosol type comprising a second pathogen; " wherein the first sensor is configured to detect presence of aerosol of the first aerosol type comprising the first pathogen; wherein the second sensor is configured to detect presence of aerosol of the second aerosol type comprising the second pathogen (collection surface would be capable of collecting the first aerosol sample).
Claim 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mainelis (US Pub 2019/0039076), in view of Relle (US Pub 2008/0281528), and further in view of Meagher (US Patent 11,366,116).
Regarding Claim 11, modified Mainelis teaches the pathogen detection system of Claim 1: wherein the set of reagent reservoirs is loaded with the set of reagents: corresponding to the defined detection assay comprising an isothermal amplification assay (Meagher teaches isothermal amplification in Example 1); comprising a reaction buffer and a set of lyophilized reagent beads associated with the isothermal amplification assay (The device can include one or more separation/extraction components (e.g., filters, posts, membranes, weirs (optionally including beads). See Additional Components section; and58 of 64PPPY-M04-U S configured to react with a pathogen sample comprising charged bioaerosols collected on the collection surface to generate a set of fluorescence signals representing presence of the set of pathogens; wherein the optical sensor is configured to record the set of fluorescence signals generated in the reaction chamber responsive to execution of the isothermal amplification assay; and further comprising a controller configured to: read the set of fluorescence signals from the optical sensor; and o interpret presence of the set of pathogens in the pathogen sample based on the set of fluorescence signals (see teachings of Meagher regarding the reagents specifically in Claim 9 and regarding the sensor see teachings of Mainelis. Meagher teaches the processing module may include one or more processing units, such as one or more processors. In some examples, the processing module may include a controller. The processing module may develop these control signals in accordance with input from an operator and/or in accordance with software. The software may include one or more executable instructions (e.g., stored on one or more memories) configured to cause the processing module to output a predetermined sequence of control signals, to perform one or more calculations (e.g., determine the presence or absence of a target based on electronic signals from the detection module), to communicate any useful output (e.g., a result, a setpoint, a level, etc.) over a network, to store any useful output in memory, and/or display any useful output on a display module. Col. 8, lines 39-67 and Col. 9, lines 1-4.).
Claims 13, 14, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mainelis (US Pub 2019/0039076), in view of Jansen (US Pub 2013/0045496).
Regarding Claim 13, Mainelis teaches the pathogen detection system of Claim 12.
Mainelis is silent to a communication module configured to: generate a notification comprising a prompt to remove the cartridge from the receptacle and insert the second cartridge into the receptacle; and transmit the notification to a user associated with an environment containing the air sampler responsive to expiration of the first sampling period and prior to initiation of the second sampling period.
Jansen teaches in the related art of detecting micro-organisms in a fluid sample. [0066] Preferably, the system comprises communication means, for example for remote control of the module. Further examples include a display, a light signal or a sound signal for communicating an alarm, for example. [0067] An advantage of the communication means is that by generating a control signal, such as for example an alarm signal or a process control signal. The examiner notes that a communication module would be capable of being configured to do these steps of generating and transmitting.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a communications module, as taught by Jansen, to the device of Mainelis, to allow for process control signaling, as taught by Jansen in [0066].
Regarding Claim 14, Mainelis teaches the pathogen detection system of Claim 1.
Mainelis is silent to a cleaning module configured to sanitize surfaces of the air sampler and the cartridge between sampling periods to prevent sample contamination.
Jansen teaches in the related art of detecting micro-organisms in a fluid sample. [0104] Flushing comprises for example discharging a sample from the module to a waste container or cleaning the fluid chamber using a flushing fluid. This ensures that no residues are present during preparation of a fluid sample. [0184] A further step can comprise cleaning the filter by using a backwash procedure. [0185] A further cleaning step can comprise opening valves 350, 352 and/or valve 366, to clean conduit loop 346 and detection part 306 as well. Furthermore, an additional step can comprise flushing the conduits using the buffer fluid to remove all chlorine solution from the system.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a cleaning module as taught by Jansen to the device of Mainelis, to allow for avoiding residues, as taught by Jansen in [0104].
Regarding Claim 23, Mainelis teaches the method of Claim 13, wherein the set of sensors is configured to generate the set of signals representing presence of aerosol particles comprising a set of pathogens collected on the set of collection surfaces; and wherein the controller is configured to interpret presence of the set of pathogens in air flowing through the flow path based on the set of signals (the set of sensors would be capable of generating a set of signals and the controller would be capable of interpreting a set of pathogens).
Regarding Claim 24, Mainelis teaches the system of Claim 13, further comprising a controller configured to interpret presence of aerosol particles in air flowing through the flow path based on the set of signals (the controller would be capable of interpreting the presence of aerosol particles).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mainelis (US Pub 2019/0039076), in view of Relle (US Pub 2008/0281528), and further in view of Jovanovich (US Pub 2008/0014576).
Regarding Claims 19 and 20, modified Mainelis teaches the pathogen detection system of Claim 15 and wherein the set of sensors comprises an optical sensor and configured to read an optical signal from fluid in the array of reaction microwells for interpreting presence of a particular pathogen, in the set of pathogens (Mainelis teaches for example optical particle counter)
Modified Mainelis is silent to wherein the cartridge comprises: a set of reagent reservoirs coupled to the substrate and containing a set of reagents corresponding to a detection assay; an array of reaction microwells fluidly coupled to the set of collection surfaces and the set of reagent reservoirs; and a set of microfluidic channels configured to transport fluid to the set of reaction microwells; wherein the air sampler further includes: a genetic material load detector arranged in the flow path and configured to detect presence of organic matter in air flowing through the flow path; and a genetic sequencer configured to receive pathogen samples from the set of collection surfaces to detect presence of the set of pathogens in pathogen samples collected on the set of collection surfaces.
Jovanovich teaches in the related art of samples from air to detect target pathogens.[0061] he microchips disclosed herein can be manufactured by microfabrication techniques known in the art and can comprise valves, pumps, chambers, channels, reservoirs etc. and can be suitable for processing or analyzing one or more target analytes [0065] In some embodiments, one or more analytical methodologies can be performed on a microchip in a channel, reservoir, reaction chamber, etc. or combinations thereof. [0109] add reagents [0157] In some embodiments, an integrated MINDS system can automate and miniaturize all processes for shotgun sequencing, directed sequencing, and resequencing. The MINDS System can create a microbead-based fluorescent DNA .mu.CAE sequencer with 100-fold, or more, lower operating costs that leverages the existing sequencing infrastructure. Each system can perform completely automated sequencing with unattended operation for up to one week with mini-robotic microfluidics replacing full-scale robotics. See also abstract, DNA sequencing.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a set of reagent reservoirs coupled to the substrate and containing a set of reagents corresponding to a detection assay; an array of reaction microwells fluidly coupled to the set of collection surfaces and the set of reagent reservoirs; and a set of microfluidic channels configured to transport fluid to the set of reaction microwells; wherein the air sampler further includes: a genetic material load detector arranged in the flow path and configured to detect presence of organic matter in air flowing through the flow path; and a genetic sequencer, as taught by Jovanovich, to the device of modified Mainelis, to allow for sample preparation and analysis systems for various applications, such as DNA sequencing and genotyping, proteomics, pathogen detection, diagnostics and biodefense, as taught by Jovanovich, in the Abstract.
Response to Arguments
Applicant’s arguments, see page 15, filed 9/5/25, with respect to the statutory double patenting rejection have been fully considered and are persuasive. The statutory double patenting rejection of claims 1-20 has been withdrawn.
However, the examiner notes that there is a new nonstatutory double patenting rejection in light of the amendment. The amendment contains broader terms than the issued patent. Further, prior art is cited in light of the amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JB/
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798