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 .
Detail Action
Claims 1-12 submitted on 7/23/2026 are pending for examination.
Applicants’ election on 7/23/2026 without traverse of group I (claims 1-4, 7-10) directed to a preparation method of a rapidly constructed three-dimensional model of a microbial film exposed at an air-liquid interface, comprising: (1) construction of a hydrogel precursor of a core: first, sealing a non-biotoxic and low-temperature congealable hydrogel material and polyvinyl alcohol in their dry states, respectively, and then performing high-temperature and high-pressure sterilization at 1150C to 131 C for 18-24 min; subsequently, mixing the sterile hydrogel material with the sterile polyvinyl alcohol and swelling the mixture in a culture medium required for immobilizing target microorganisms for 15-45 min, dissolving the mixture at 90°C to 1000C, and maintaining the mixture at 600C to 800C for later use; dissolving an antimicrobial chitosan hydrochloride in a solution of a non-biotoxic reagent that is soluble or sparingly soluble in water and capable of releasing calcium ions, and performing a sterilization by filtering with a 0.22 pm sterile nylon filter head; mixing the prepared hydrogel-polyvinyl alcohol mixed solution with the chitosan hydrochloride solution in a specific mass ratio to ensure that an obtained mixture contains 2-12% of the low-temperature congealable hydrogel, 8-12% of the polyvinyl alcohol, 1-1.5% of the chitosan hydrochloride, 1-1.5% of the calcium ion reagent, and sufficient nutrients; to give a core of a three-dimensional model; (2) pouring the hydrogel precursor of the core into a silicone mold designed according to a desired structure, sealing the hydrogel precursor of the core at 2°C to 8°C for 1-4 h until the low-temperature congealable hydrogel in a liquid state completely solidifies to form a scaffold; allowing the scaffold to undergo freezing at -20°C to -86°C for 12-24 h, thawing at room temperature for 12-24 h, and then freezing at -20°C to - 860C for additional 12-24 h, and repeating the cycle three times to obtain a scaffold with enhanced gel strength; (3) construction of a hydrogel precursor for microbial culture: first, sealing sodium alginate in its dry state, and then performing high-temperature and high-pressure sterilization at 1150C to 131 C for 18-20 min; subsequently, adding the sterile sodium alginate to a sterile Tris-HCI buffer of 4-6 mmol/L containing salt ions required for immobilizing target microorganisms to finally ensure that an obtained mixture contains 0.6-0.8% of the sodium alginate;(4) culture of immobilized microorganisms: culturing the target microorganisms in a microorganism solution state for 14-18 h, and performing low-temperature centrifugation at 5,000-7,000 rpm at 20C to 8°C for 5-10 min; washing the microorganisms collected by centrifugation with a sterile Tris-HCI buffer of 4-6 mmol/L three times, mixing the microorganisms evenly into the hydrogel precursor for microbial culture, and performing a vortex mixing for 1-3 min to form a shell composed of highly biocompatible sodium alginate, which combines with a buffer system and salt ions to ensure normal survival of the microorganisms in a short period;(5) formation of a biofilm-like film: fully immersing the prepared scaffold in the hydrogel precursor for microbial culture containing the immobilized microorganisms, wherein the chitosan hydrochloride as a cationic polymer first interacts with the sodium alginate as an anionic polymer to form a polyelectrolyte layer which quickly envelopes the entire core scaffold to create an antimicrobial layer to prevent microbial invasion into the core scaffold; subsequently, gradually releasing the calcium ions in the calcium ion- containing reagent in the scaffold into the hydrogel precursor for microbial culture to gradually form a calcium alginate hydrogel film around the core scaffold, thus immobilizing the microorganisms in the hydrogel precursor for microbial culture on a surface of the core scaffold, wherein there is a linear positive correlation between a film thickness and the immersion of the core scaffold within a certain period of time, with the film thickness varying at a rate of 50 pm/min;(6) stabilization of the model of the biofilm-like film: stabilizing the constructed three- dimensional model of the microorganisms in a sterile Tris-HCI buffer of 4-6 mmol/L containing nutrients required for the immobilized microorganisms at 2°C to 8°C for 5-10 min, thus facilitating replenishment of nutrients in the scaffold under action of material exchange, where the chitosan hydrochloride in the core undergoes a deprotonated crosslinking and further strengthens the gel strength of the scaffold under action of the Tris-HCI buffer; and(7) construction of a microbial film exposed at an air-liquid interface: purging the model of the biofilm-like film by high-purity air at a flow rate of 0.4-0.8 L/min for 4-8 min so that the film layer rapidly shrinks to a hydrogel film with a thickness of no more than 50 pm due to a greater dehydration rate of the sodium alginate as compared to that of the mixed hydrogel of the scaffold, to compel some microorganisms immobilized therein to be exposed at the air-liquid interface in response to election/restriction office action of 6/102026
is acknowledged. Claims 5-6, 11-12 comprise non-elected subjected are withdrawn. Claims 1-4, 7-10 are for examination. Election made final.
Claim Rejections: 35 USC § 112(b)
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.
Claim claims 1, 7 and 2-4, and 8-10 (depends on claim 1 and claim 7) 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
Claim 1 is indefinite in reciting “rapidly constructed three-dimensional model of a microbial film” because it is unclear how rapid the construction is.
Rapidly is relative term. It should be defined by quantitively by a time, if available. Correction is required.
Claim 1 is indefinite in reciting “mixing the sterile hydrogel material with the sterile polyvinyl alcohol and swelling the mixture in a culture medium required for immobilizing target microorganisms for 15-45 min ; subsequently, mixing the sterile hydrogel material with the sterile polyvinyl alcohol and swelling the mixture in a culture medium required for immobilizing target microorganisms for 15-45 min, dissolving the mixture at 90°C to 1000C, and maintaining the mixture at 600C to 800C for later use; dissolving an antimicrobial chitosan hydrochloride in a solution of a non-biotoxic reagent that is soluble or sparingly soluble in water and capable of releasing calcium ions, and performing a sterilization by filtering with a 0.22 pm sterile nylon filter head; mixing the prepared hydrogel-polyvinyl alcohol mixed solution with the chitosan hydrochloride solution in a specific mass ratio to ensure that an obtained mixture contains 2-12% of the low-temperature congealable hydrogel, 8-12% of the polyvinyl alcohol, 1-1.5% of the chitosan hydrochloride, 1-1.5% of the calcium ion reagent” because of following reason:
AS seen already hydrogel-polyvinyl alcohol mixture already prepared by mixing them in the 1st instant and then how in the 2nd mixing the ratio as disclose : mixing the prepared hydrogel-polyvinyl alcohol mixed solution with the chitosan hydrochloride solution in a specific mass ratio to ensure that an obtained mixture contains 2-12% of the low-temperature congealable hydrogel, 8-12% of the polyvinyl alcohol, 1-1.5% of the chitosan hydrochloride, 1-1.5% of the calcium ion reagent be attained is unclear. The process is unclear and confusing. Correction required.
Claim 1 is indefinite in reciting “ sufficient nutrients” because it is unclear how much is sufficient. It should be defined by quantitively , if available. Correction is required.
Claim 1 is indefinite in reciting “the calcium ion reagent” because it lacks antecedent basis..
Claim 1 (4) is indefinite in reciting “highly biocompatible sodium alginate” because it lack antecedent basis.
Claim 4 is indefinite in reciting “biofilm-like film” . It is unclear what type of film is biofilm-like
Claim 4(1) is indefinite in reciting “substances in the air” . It is unclear what type of substances are there in the air.
Claim 7 is indefinite in reciting “ sufficient nutrients” because it is unclear how much is sufficient. It should be defined by quantitative amount, if available. Correction is required.
Claim 7 is indefinite in reciting “the calcium ion reagent” because it lack antecedent basis..
Conclusion
Claims 1-4, 7-10 are rejected and no claim is allowed.
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Mohammad Meah whose telephone number is 571-272-
1261. The examiner can normally be reached on 8:30-5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
supervisor, Robert Mondesi can be reached on 4089187584. The fax phone number
for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMAD Y MEAH/Examiner, Art Unit 1652
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