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 .
Status of the Claims
Claims 1-3, 5-15, 33, 35-36, 41, 43-44, and 46 are currently pending (claim set as filed on 2/21/2024). Claims 33, 35-36, 41, 43-44, and 46 are withdrawn following a restriction/election requirement. Claims 4, 16-32, 34, 37-40, 42, and 45 are cancelled. Claims 1-3 and 5-15 are under examination.
Election/Restrictions
Claims 33, 35-36, 41, 43-44, and 46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected system, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/29/2026.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. SG 10202108515R, filed on 8/4/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, and thus the effective filing date of this application is 8/4/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/31/2024 was considered, initialed, and attached hereto. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The use of the term “Triton X” and “PBS”, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-3 and 5-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mazza (Pre-Grant Publication No. US 2018/0214609 A1 – date of publication 8/2/2018).
Mazza’s general disclosure relates to a method of producing decellularized tissue scaffolds by subjecting a tissue sample to a reagent wash and an oscillating treatment (see abstract).
Regarding claim 1, Mazza teaches a method of producing a decellularized tissue scaffold by use of a cassette with a tissue-accommodating chamber immersed in a reagent (see Mazza [0215-0217]) and wherein the reagent may pass from the tissue chamber to a reservoir chamber via a conduit (see Mazza [0218-0220]). The instant specification discloses the reactor chamber may comprise a port which acts as an inlet and outlet for admitting fresh reagents and removing used reagents (see specification pg. 7, ¶ 1), and thus the reservoir chamber reads on the claimed limitation. The reservoir chamber is filled with a volume of reagent which then flows to the tissue chamber to immerse the tissue sample in reagent (see Mazza [0237]), and the tissue sample still within the tissue chamber is washed one or more times with reagents using a pump and oscillator device (see Mazza [0222]), which would agitate the tissue sample. The reagent is monitored for optical properties such as turbidity via sensors (see Mazza [0230-0231]) that are linked to actuators which can alter conditions, such as wash cycles logically, in the tissue chamber in response (see Mazza [0233-0234]).
Regarding claims 2-3, Mazza teaches the sensors monitor the pH of the reagent (see [0231]). The instant application provides no definition for the meaning of the term, and therefore under broadest reasonable interpretation a sensor that calculates the value of the pH of the reagent in real-time reads on the claimed limitation.
Regarding claim 5, Mazza teaches monitoring the optical properties of the tissue sample using a UV/vis microplate reader to determine spectroscopic properties such as absorbance (see [0315]).
Regarding claims 6-7, Mazza teaches the processor can alter the rate of flow or pressure of the reagent based on sensor feedback monitoring the tissue sample (see [0273-0274]). The ordinary artisan would have been able to anticipate that the sensor feedback would be in response to a washing cycle and thus the altering would occur within a wash cycle. Mazza also teaches that the tissue samples can be washed at least two times (see [0035]), and this would be implicit as the prior art teaches the wash cycles may be adjusted and thus more than one wash must occur in order to do so.
Regarding claim 8, Mazza teaches the reservoir chamber is filled with reagent from the below the tissue sample as the movement of reagents flowing out of the tissue chamber is driven by gravity, and thus one could reasonably interpret that the reservoir chamber was physically below the tissue sample in order for gravity to direct the flow of reagent towards it. As noted in the 112b rejection above, the claim is rendered indefinite as it is unclear from the language used what the physical relation is between the reactor chamber and the tissue sample. For examination purposes, the claim language is interpreted to mean the reactor chamber is physically below the tissue sample.
Regarding claim 9, Mazza teaches the tissue pathology characteristics (i.e. viral infections, alcohol damage, fibrosis) are determined initially before the method steps (see [0026]).
Regarding claim 10, Mazza teaches that reagents can be changed when the sensors determine a certain concentration threshold is surpassed (see [0274]), which would alter their amount and concentration in the tissue chamber.
Regarding claim 11, Mazza teaches the processor alter the rate of the flow of the reagents (see [0273]), which would change their speed and duration.
Regarding claim 12, Mazza teaches that sensors can monitor conditions in the reagent wash and send feedback to the processor to make adjustments (see [0267] and [0273]) and also discloses that the tissues can be washed multiple times (see [0035]). This reads on adjusting.
Regarding claim 13, Mazza teaches that after the oscillation wash cycle is complete, the reagents are drained from the cassette while the tissue samples are retained within their chamber (see [0295]). Mazza also discloses that there is a membrane that prevents the tissue sample from leaving the tissue chamber though the conduits into the reservoir chambers with the reagent (see [0251]).
Regarding claim 14, Mazza teaches that during the process of draining the reagents out of the cassette, which includes the decellularized tissue scaffold in the tissue chamber, filtered air replaces any remaining reagent left (see [0295]). Under broadest reasonable interpretation, the filtered air treatment reads on a clearing wash cycle.
Regarding claim 15, Mazza teaches that the processor can change a wash cycle by altering the reagents used when the sensor determines that a particular concentration of molecules surpasses a specified threshold (see [0273-0274]).
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMALEE R WILLIAMS/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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