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 .
DETAILED ACTION
1. Claims 1-4, 7-13 are under consideration.
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
3. The information disclosure statement (IDS) was submitted on 6/2/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
4. Claims 1, 3, 4, 13 are objected to because of the following informalities:
As to claim 1, for improved language, the claim should recite “organisms present”.
As to claims 3, 4, the claim should recite a comma after “claim 3” to be consistent with the other claims (for example, recite “… claim 3, further…”).
As to claim 4, the claim lacks punctuation.
As to claim 13, the claim should be consistent with claim 8, reciting “viruses”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. Claims 1-4, 7-13 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.
See claims 1-4, 7-13 as submitted 6/2/2023.
As to claim 1, the claim recites PTFE filter and subsequently, a “filter”. It is not clear if this is the same filter or not.
Further, claims 1, 7 recite “communicatively coupled” as well as “processor”. It is noted that claim 1 reads on at least one filter (substrate using filter) and at least one processor. It is not clear how the components work together. The processor is only required to “enable air to flow”, which reads on an open aperture or passive function. It is not clear how air is processed or needs to be processed. Additionally, it is not clear what needs to be communicated, as the processor reads on a passive function (“enable air to flow”) and substrate only uses filter. It is not clear what the metes and bounds or working relationship of said claim terms are.
Claim 1 also recites “organism” and “cellular organisms”. It is not clear if the
organisms are the same or not. Further the claim recites “particles” and “organisms”. It is not clear if these read on the same components or not.
Claim 1 also recites “the virus particles”. There is insufficient antecedent basis for this limitation in the claim.
Further as to claim 2, the claim recites “the particles”. It is not clear if these are the virus particles recited in claim 1 or not.
Further as to claim 3 recites “all non-encapsidated DNA or RNA”. It is not clear what the source of the nucleic acids is.
Further as to claim 4, the claim recites “for all, or specific viral genomes” as well as “specific virus or collective viruses”. It is not clear what is being referred to and if these refer to the virus particles as recited in claim 1 or not.
As to claim 7, the claim recites “organisms” then “particles”. It is not clear if these are the same or not. Further as to step (b) the claim recites “the genetic material”. There is insufficient antecedent basis for this limitation in the claim. Further, the claim recites “the device”. There is insufficient antecedent basis for this limitation in the claim.
Further as to claim 9, the claim recites “cellular organisms”. It is not clear if this refers to organisms as recited in claim 7 or not.
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.
6. Claims 1-4, 7-13 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.
See claims 1-4, 7-13 as submitted 6/2/2023.
See also the 35 U.S.C. 112(b) rejection above.
Claims 1, 7 recite “at least one processor operable to enable the air to flow through or over the substrate, thereby causing the particles in the air to be captured by the substrate”.
Each of the claims is drawn, inherently or explicitly, to any processor operable to enable the air to flow through or over the substrate, thereby causing the particles in the air to be captured by the substrate. Further, claim 2 recites processor operable to cause air pump to increase or decrease flow of air. Thus, the claims are drawn to a genus of processors.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the specification: recites the term processor, but does not teach a specific one.
There is no apparent common conserved structure to the different processors that distinguishes those that enable the air to flow through or over the substrate, thereby causing the particles in the air to be captured by the substrate as compared to those that do not. There is therefore a high level of uncertainty as to which processors fall within the scope of the indicated genus.
Further, the specification has identified processors only by function: the ability to enable the air to flow through or over the substrate, thereby causing the particles in the air to be captured by the substrate. The specification does not provide a specific structure of any processor within the genus that correlates with the required function. Because there is no identification of structures common to each processor, nor sufficient representative examples of the processor by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of processors through identification of a structure and function. While the processors are required to enable the air to flow through or over the substrate, thereby causing the particles in the air to be captured by the substrate, this is not alone sufficient structure to correlate with the function. This is because the mere presence of a processor does not demonstrate that the processor would be enable the air to flow through or over the substrate, thereby causing the particles in the air to be captured by the substrate.
For the reasons above, and in view of the uncertainty as to structure of the claimed processors, the application has not provided sufficient written description support for the genus of processors identified in claims 1, 7. The application therefore fails to provide adequate support for methods of using this genus of processors.
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.
7. Claims 1, 2 are rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al. (“Airborne Influenza A Virus Exposure in an Elementary School,” Scientific Reports 10:1859 (2020))(See PTO-892: Notice of References Cited) as evidenced by MagMAX (“MagMax Viral RNA Isolation Kit,” Manual 1939M, Revision D: Ambion Inc. (2008))(See PTO-892: Notice of References Cited) in view of Bekking et al. (“Evaluation of bioaerosol samplers for the detection and quantification of influenza virus from artificial aerosols and influenza virus-infected ferrets,” Influenza Other Respi Viruses, 13:564-573 (2019))(See PTO-892: Notice of References Cited).
See claims 1, 2 as submitted 6/2/2023.
See also the 35 U.S.C. 112(b) rejection above.
Coleman et al. teaches: bioaerosol sampling (p. 4); using bioaerosol cyclone samplers provided by NIOSH (p. 4); connected to pumps operating at a flow rate collecting 840L of air for each sample (p. 4)(as recited in claim 2); use of PTFE filter with 2 µm pores (p. 4)(as recited in claim 1); as each sampler collects particles into tubes or filters, as well as Coleman et al. teaching efficient capture of airborne influenza virus RNA (p. 4), the samplers are considered to have processors enabling air to flow through or over substrate, thereby causing the particles in the air to be captured by the substrate, as well as communicatively coupled (as recited in claim 1); as well as centrifuge tubes (p. 4); wherein lysis/binding solution was added to tubes and tubes containing PTFE filters (interpreted as buffer as recited in claim 1). Coleman et al. also teaches use of MagMAX Viral Isolation kit for extracting RNA (p. 4).
MagMAX is cited in support of Coleman et al. to teach: tubes (p. 3); buffers (p. 3); vortex mixer (p. 4); stand (for centrifuge tubes)(p. 4); protocol including: mixing and centrifugation to collect contents at the bottom of tube (p. 8); adding beads and centrifuge step (p. 8); capturing beads and discarding supernatant (p. 8)(all interpreted as centrifugal unit and filter as recited in claim 1); wash, dry, elution, analysis steps (pp. 8-10).
Coleman et al. as evidenced by MagMAX does not teach: PTFE with pore size of 1 µm or 5 µm.
Bekking et al. teaches: bioaerosol sampling; collecting viral RNA, including for influenza virus (p. 564); including using PTFE filters and NIOSH cyclone sampler (p. 564); including with filters of 1.0 µm pore size (p. 566).
One of ordinary skill in the art would have been motivated to use filter as taught by Bekking et al. with the system as taught by Coleman et al. as evidenced by MagMAX. Coleman et al. as evidenced by MagMAX teaches use of NIOSH samplers with PTFE filters for collecting influenza virus particles, and Bekking et al., which also teaches use of NIOSH samplers with PTFE filters for collecting influenza virus particles, teaches such a pore size known and used with PTFE filters and NIOSH samplers (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using filter as taught by Bekking et al. with the system as taught by Coleman et al. as evidenced by MagMAX. There would have been a reasonable expectation of success given the underlying materials (PTFE filters as taught by Bekking et al. and Coleman et al. as evidenced by MagMAX) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
8. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al. evidenced by MagMAX in view of Bekking et al. as applied to claims 1, 2 above, and further in view of Hall et al. (“Evaluation of rapid and simple techniques for the enrichment of viruses prior to metagenomic virus discovery,” Journal of Virological Methods 195: 194-204 (2014))(See PTO-892: Notice of References Cited).
See claim 3 as submitted 6/2/2023.
See also the 35 U.S.C. 112(b) rejection above.
See the teachings of Coleman et al. evidenced by MagMAX in view of Bekking et al. above.
Coleman et al. evidenced by MagMAX in view of Bekking et al. does not teach: nuclease treatment.
Hall et al. teaches: use of metagenomics and sequencing for viruses (abstract); including enrichment techniques to increase viral sequences and enhance probability of detection (abstract); including use of nuclease treatment; centrifugation, filtration and nuclease treatment showed the greatest increase in the proportion of viral sequences (abstract).
One of ordinary skill in the art would have been motivated to use nuclease treatment as taught by Hall et al. with the system as taught by Coleman et al. evidenced by MagMAX in view of Bekking et al. Coleman et al. evidenced by MagMAX in view of Bekking et al. teaches use of virus sample and detection thereof, and Hall et al., which also teaches virus sample and detection thereof, teaches the advantage of nuclease treatment steps for enhancing probability of detection of viruses.
One of ordinary skill in the art would have had a reasonable expectation of success for using nuclease treatment as taught by Hall et al. with the system as taught by Coleman et al. evidenced by MagMAX in view of Bekking et al. There would have been a reasonable expectation of success given the underlying materials and methods (virus detection as taught by Hall et al. and Coleman et al. evidenced by MagMAX in view of Bekking et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
9. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al. evidenced by MagMAX in view of Bekking et al. in view of Hall et al. as applied to claim 3 above, and further in view of Rosario et al. (“Diversity of RNA and RNA Viruses in Indoor Air As Assessed via Metagenomic Sequencing,” Environ. Sci. Technol. 52: 1014-1027 (2018))(See PTO-892: Notice of References Cited).
See claim 4 as submitted 6/2/2023.
See the teachings of Coleman et al. evidenced by MagMAX in view of Bekking et al. in view of Hall et al. above.
Coleman et al. evidenced by MagMAX in view of Bekking et al. in view of Hall et al.
does not teach: gene amplifier and sequencers.
Rosario et al. teaches: investigation of viruses circulating in the air (abstract); sequencing to determine identity and diversity of viral particles (abstract); use of amplification kits (p. 1015); PCR (p. 1016, 1022).
One of ordinary skill in the art would have been motivated to use amplification and sequencing as taught by Rosario et al. with the system as taught by Coleman et al. evidenced by MagMAX in view of Bekking et al. in view of Hall et al. Coleman et al. evidenced by MagMAX in view of Bekking et al. in view of Hall et al. teaches investigation of airborne pathogens using nucleic acids, and Rosario et al., which also teaches investigation of airborne pathogens using nucleic acids, teaches the advantage of steps known and used in the art to further identify and characterize airborne pathogens.
One of ordinary skill in the art would have had a reasonable expectation of success for using amplification and sequencing as taught by Rosario et al. with the system as taught by Coleman et al. evidenced by MagMAX in view of Bekking et al. in view of Hall et al. There would have been a reasonable expectation of success given the underlying materials and methods (investigation of airborne pathogens as taught by Rosario et al. and Coleman et al. evidenced by MagMAX in view of Bekking et al. in view of Hall et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
10. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al. evidenced by MagMAX in view of Bekking et al. as applied to claims 1, 2 above, and further in view of Pan et al. (“Collection, particle sizing and detection of airborne viruses,” Journal of Applied Microbiology, 127: 1596-1611 (2019))(See PTO-892: Notice of References Cited).
See claim 11 as submitted 6/2/2023.
See the teachings of Coleman et al. evidenced by MagMAX in view of Bekking et al. above. It is noted Coleman et al. teaches: AirChek pump (p. 4).
Coleman et al. evidenced by MagMAX in view of Bekking et al. does not teach: vacuum pump.
Pan et al. teaches: samplers and cyclones for sampling airborne viruses (p. 1598); use of vacuum pump (p. 1598).
One of ordinary skill in the art would have been motivated to use pump as taught by Pan et al. with the system as taught by Coleman et al. evidenced by MagMAX in view of Bekking et al. Coleman et al. evidenced by MagMAX in view of Bekking et al. teaches the use of cyclone samplers and air pumps, and Pan et al., which also teaches the use of cyclone samplers and air pumps, teaches such an air pump (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using pump as taught by Pan et al. with the system as taught by Coleman et al. evidenced by MagMAX in view of Bekking et al. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
11. Claims 7-10, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al. as evidenced by MagMAX in view of Bekking et al. as to claims 1, 2 above and further in view of Rosario et al. (all references cited above).
See claims 7-10, 12 as submitted 6/2/2023.
See the teachings of Coleman et al. as evidenced by MagMAX in view of Bekking et al. above. See the teachings of Rosario et al. above.
One of ordinary skill in the art would have been motivated to use amplification and sequencing as taught by Rosario et al. with the system as taught by Coleman et al. evidenced by MagMAX in view of Bekking et al. Coleman et al. evidenced by MagMAX in view of Bekking et al. in view of Hall et al. teaches investigation of airborne pathogens using nucleic acids, and Rosario et al., which also teaches investigation of airborne pathogens using nucleic acids, teaches the advantage of steps known and used in the art to further identify and characterize airborne pathogens.
One of ordinary skill in the art would have had a reasonable expectation of success for using amplification and sequencing as taught by Rosario et al. with the system as taught by Coleman et al. evidenced by MagMAX in view of Bekking et al. There would have been a reasonable expectation of success given the underlying materials and methods (investigation of airborne pathogens as taught by Rosario et al. and Coleman et al. evidenced by MagMAX in view of Bekking et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
12. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al. evidenced by MagMAX in view of Bekking et al. and Rosario et al. as applied to claims 7-10, 12 above, and further in view of Chia et al. (“Detection of air and surface contamination by SARS-CoV-2 in hospital rooms of infected patients,” Nature Communications, 11:2800 (2020))(See PTO-892: Notice of References Cited).
See claim 13 as submitted 6/2/2023.
See the teachings of Coleman et al. evidenced by MagMAX in view of Bekking et al. and Rosario et al. above.
Coleman et al. evidenced by MagMAX in view of Bekking et al. and Rosario et al. does not teach SARS-CoV-2.
Chia et al. teaches: use of NIOSH aerosol samplers and filters for processing (p. 6); detection of SARS-CoV-2 (abstract).
One of ordinary skill in the art would have been motivated to detect SARS-CoV-2 as taught by Chia et al. with the system as taught by Coleman et al. evidenced by MagMAX in view of Bekking et al. and Rosario et al. Coleman et al. evidenced by MagMAX in view of Bekking et al. and Rosario et al. teaches viral detection, and Chia et al., which also teaches viral detection, teaches such a virus (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for detecting SARS-CoV-2 as taught by Chia et al. with the system as taught by Coleman et al. evidenced by MagMAX in view of Bekking et al. and Rosario et al. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A. Coleman et al. (“Bioaerosol Sampling for Respiratory Viruses in Singapore’s Mass Rapid Transit Network,” Scientific Reports, 8: 17476 (2018))(See PTO-892: Notice of References Cited) teaches: PTFE filter removed from NIOSH sampler cassettes and transferring to Falcon tube for vortexing (p. 5).
14. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672