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 § 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.
Claim(s) 1-21is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jovanovich (WO 2019232504).
Regarding Claim 1, Jovanovich teaches an apparatus for processing tissue samples comprising a supporting structure (instrument) with a seat and with a rotation device (process) supplied with constraining means (Refer to Figures 5, 9 and 10) and; a container (200) for biological material, provided with a shaped body, with a base shaped to match the seat of the supporting structure (instrument) and supporting movable cutting means (grinding element) free to rotate relative to the base, and fixed cutting means (blade), suitable for promoting the fragmentation of the biological material; and with at least one valve for extracting the biological material (refer to paragraph [0153]); the movable cutting means (grinding element) being equipped with coupling means for directly coupling to the constraining means of the rotation device (motor), in such a way as to acquire a relative motion relative to the container.
Regarding claim 2, the supporting structure (instrument) comprises a dedicated software and a screen for displaying the operating specifications. (Refer to paragraph [0037])
Regarding claim 3, the container comprises at least one second valve for extracting and/or introducing biological material. (Refer to paragraph [0067])
Regarding claim 4, the base and the body of the container (200) comprise constraining means shaped to match each other, in such a way that they can be separated. (Refer to Figures 11 and 12)
Regarding claim 5, a base supporting movable cutting means free to rotate relative to the base; fixed cutting means, suitable for promoting the fragmentation of the biological material; at least one valve for extracting the biological material; the movable cutting means being equipped with coupling means for coupling to a rotation device, in such a way as to acquire a relative motion relative to the container. (Refer to paragraph [0061])
Regarding claim 6, the container comprises at least one second valve for extracting and/or introducing biological material. (Refer to paragraph [0061])
Regarding claim 7, the base and the body of the container comprise constraining means (cartridge interface) shaped to match each other, in such a way that they can be separated.
Regarding claim 8, an ultrasonic device (process, Figure 5), suitable for breaking up the biological material.
Regarding claim 9, the ultrasonic device comprises an electric generator, a converter for converting electrical energy into mechanical energy, suitable for generating ultrasonic waves, at least one sonotrode, suitable for spreading the ultrasonic waves in the biological material in such a way as to promote its disaggregation. (Refer to paragraph [0042])
Regarding claim 10, the sonotrode comprises a bottom fixed to the supporting structure, and an emitter, fixed to the container, interposed between the bottom and the emitter there being constraining means suitable for allowing their quick uncoupling. (Refer to paragraph [0042])
Regarding claim 11, wherein the constraining means comprise magnets. (Refer to paragraph [0040])
Regarding claim 12, the supporting structure comprises at least one housing shaped to match the container, suitable for accommodating it at the end of the processing. (Refer to Figures 6 and 7)
Regarding claim 13, measuring means (500) for measuring the cellular fractions of the biological material inside the container. (Refer to paragraph [0009])
Regarding claim 14, the measuring means comprise at least one spectrophotometer, suitable for detecting the absorbance of the biological material processed for defining the concentration of the cellular fractions. (Refer to paragraph [0009])
Regarding claim 15, a recognition device for recognizing the containers, suitable for unambiguously identifying each container. (Refer to paragraph [0064])
Regarding claim 16, the recognition device for recognizing the containers comprises identification means fixed to the container, a reader fixed to the supporting structure, said reader and said identification means being able to communicate by means of the dedicated software installed in the supporting structure. (Refer to paragraph [0064])
Regarding claim 17, the supporting structure comprises a transparency illuminator for checking the separation into phases of the biological material. (Refer to paragraph [0064])
Regarding claim 18, extraction of the biological material; addition of a water based solution to the extracted biological material; mechanical agitation of the mixture of biological material and water-based solution; settling, for the separation of the mixture in layers of different density; extraction of the lower layer, rich in stem cells and anti-inflammatory and growth factors, called SVF (stromal vascular fraction). (Refer to claim 1 rejection and Paragraphs [00201-00202])
Regarding claim 19, the quantity of water-based solution is between 1/5 and 5 times the quantity of biological material in volume. (Refer to paragraph [00192])
Regarding claim 20, the mechanical agitation consists in a rotation of the mixture of biological material and water-based solution at a speed between 50 and 5000 revolutions per minute for a time between 5 seconds and 5 minutes. (Refer to paragraph [00192])
Regarding claim 21, the settling has a duration ranging between 2 and 20 minutes. (Refer to paragraph [00167])
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JYOTI NAGPAUL whose telephone number is (571)272-1273. The examiner can normally be reached M-F 9am to 5pm, EST.
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/JYOTI NAGPAUL/Primary Examiner, Art Unit 1798