DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Independent claim 1 recites the limitation "the proportional turbidity signal" in lines 15-16. There is insufficient antecedent basis for this limitation in the claim. It is believed that the claim should instead read “a proportional turbidity signal”.
Claims 2-9 are rejected as being dependent on claim 1.
Regarding claim 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 3 recites the limitation "the IoT communications" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the IoT platform" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, it is unclear if the term “(coated beads)” further limits the claim. It is unclear if limitations presented in parentheses are positively recited.
Claim 9 recites the limitation "the…viral particles" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Independent claim 1 only states that microbial agents are detected and does not mention viral particles.
Claim 3 recites the limitation "the multiple union of the particle system" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
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 1, 3, 4, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sugita (US 20200057056) in view of Gjerde (US 20160017272) and Ayers (US 20250059105).
With respect to claim 1, Sugita discloses a system for the continuous detection of microbiological agents of interest in water. The system includes at least one biosensor tank (Figure 5:2011) containing nanoparticles (Figure 2:11) functionalized with at least one antibody (Figure 2:12) for antigen capture. Sugita describes in paragraphs [0073], [0074] and [0062]-[0078] that an agglutination reaction is carried out in the presence of the antigen, and that the agglutination reaction creates turbidity in the water of each biosensor tank. At least one turbidity measurement sensor (Figure 4:214) records a turbidity signal based on the amount of microorganism captured in the biosensor tank, and a control unit (Figure 3:2,3,9) monitors, records and processes information provided by the turbidity measurement sensor and controls the operation of the system. Paragraphs [0111]-[0113] and [0131] state that a heater and a temperature sensor are used to regulate the temperature of water within the biosensor tank. Sugita, however, does not indicate that the biosensor tank includes a water level sensor or inlet and outlet ports having inlet and outlet filters.
Gjerde discloses a system for the detection of microbiological agents comprising at least one biosensor tank (Figure 12:“Cell Stationary Phase”) provided with an inlet and an outlet. Inlet (Figure 3A:50) and outlet (Figure 3A:56) filters are used to retain functionalized particles (Figure 3A:48) within the biosensor tank. This is described in paragraphs [0049]-[0052].
Ayers discloses a cell culture system comprising a plurality of biotanks (Figure 1:16) having an inlet and outlet for process water. Paragraphs [0085]-[0091] state that sensors are provided for measuring turbidity and the water level within each biotank.
Before the effective filing date of the claimed invention, it would have been obvious to provide the Sugita biosensor tanks with an inlet having an inlet filter and an outlet having an outlet filter. Gjerde teaches that this structure allows for the quick and automated delivery of a sample fluid into the biosensor tank while ensuring that functionalized particles remain in the tank for repeated use in future detection routines. It additionally would have been obvious to provide each of the Sugita biosensor tanks with a water level sensor. Ayers indicates that water level sensors are commonly used in the art to maintain adequate water volumes and regulate cell density.
With respect to claim 3, Sugita, Gjerde and Ayers disclose the combination as described above. Sugita, Gjerde and Ayers indicate that the detection units are configured to detect different pathogens. Sugita, Gjerde and Ayers further describe the state of the art regarding IoT communications with a cloud platform and antenna for transmitting data. See, for example, paragraphs [0096]-[0099] of Ayers and paragraphs [0105]-[0107] of Sugita. Sugita shows in Fig. 3 an electrical cabinet and power supply.
With respect to claim 4, Sugita, Gjerde and Ayers disclose the combination as described above. Sugita shows a plurality of biosensor tanks 201 provided in parallel in Fig. 4. Ayers likewise shows a plurality of biosensor tanks 106 provided in parallel.
With respect to claim 8, Sugita, Gjerde and Ayers disclose the combination as described above. Sugita indicates that turbidity measurements are used to identify an agent or a specific contaminant present in the sample water (“the presence or absence of the complex can be determined by a visual observation or a turbidity measurement…If the turbidity is high, the complexes agglutinate, suggesting that a detection substance is present”).
With respect to claim 9, Sugita, Gjerde and Ayers disclose the combination as described above. Sugita states in paragraphs [0031] and [0032] that the nanoparticles are functionalized latex nanoparticles coated with a monoclonal antibody that captures microbial agents or viral particles. As previously discussed, Sugita teaches that nanoparticles are agglutinated in the presence of a target to create frameworks that produce a detectable change in turbidity.
Allowable Subject Matter
Claims 2 and 5-7 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Sugita is the closest prior art for the reasons expressed above. As for claim 2, there does not appear to be a reason or motivation to further modify Sugita to include membrane disc filters having hydrophobic surfaces and a pore size of about 200 nm. As for claims 5-7, features such as inlets, conduits, valves, tanks, level sensors, pumps, etc. are independently known in the art. However, there the references do not provide instruction regarding how to arrange them together so as to arrive at the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Sklavounos (US 20220203364) and Chen (US 20200158628) references teach the state of the art regarding agglutination assays comprising nanoparticles.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
Prosecution Insights