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 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.
Claims 14-19 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.
Claim 14 was amended to have the limitation of “wherein the microcontainer lacks exogenous extracellular matrix components”. Applicant directs support for this limitation to paragraphs 21 and 27. Although the culturing medium and culturing does not contain any exogenous extracellular matrix, the examiner cannot locate support for the microcontainer lacking extracellular matrix components. While the culturing medium put in the microcontainer does not contain extracellular matrix components, the microcontainer itself is never disclosed as lacking these components.
Claims 15-19 are further rejected as they depend from Claim 14.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deutsch et al. (US20060240548A1).
Regarding Claim 14, Deutsch teaches the following:
A gel carrier 50 and a cover slip 52 define a sealed volume including a matrix of wells (para 200) and the carrier where at least one component (preferably the carrier, a cover, or both) is made of a hydrogel (para 37-38)(a microcontainer comprising walls composed of a hydrogel and a hydrogel lid wherein once cells and culturing medium are loaded in the microcontainer, the hydrogel walls and lid prevent the cells from escaping)
Active entities (in solution) are added by contacting it with the surface of the gel and over time, it diffuses into and through the gel to the vicinity of the cells (para 205)(allow air and liquid exchange with the environment)
Deutsch further teaches this container to not contain any cell binding materials as paragraph 19 discusses the binding mat compromise experimental results.
Regarding Claim 15, Deutsch teaches all of the limitations of Claim 14 (see above). Deutsch further teaches gels suitable for use in making a component of a device of the present invention include but are not limited to agar gels, agarose gels, gelatins, low melting temperature agarose gels, alginate gels (para 39)(the hydrogel material includes agarose, gellan, alginate hydrogels or a combination thereof).
Regarding Claim 16, Deutsch teaches all of the limitations of Claim 15 (see above). Deutsch further teaches the dimensions of the wells are generally less than about 200, 100, 50, 25 or even 10 microns (microcontainer to have a diameter between about 100 µm and 150 µm). By dimensions is meant the usual meaning of the word and is dependent on the shape of the well. For example, for hexagonal or circular wells, the term dimension refers to diameter (para 139). Deutsch further teaches the size of the wells of a device is changeable (para 115).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Deutsch et al. (US20060240548A1) in view of Yanagawa et al. (US20160361466A1).
Regarding Claim 17, Deutsch teaches all of the limitations of Claim 16 (see above). Deutsch does not explicitly teach the depth between about 100 µm and 350 µm.
Yanagawa teaches a device to generate kidney organoids (Abstract). Yanagawa further teaches the cell chamber depth to vary between 50 and 400 µm and the dimensions and overall size will vary depending upon the expected size of the organoid (para 64). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the microcontainer of Deutsch to fit the size of the organoid and have a depth of 100 µm and 350 µm as taught by Yanagawa. One would have been motivated to make this modification as it would allow the accommodation of the organoid and a change in size or shape has been held prima facie obvious. See MPEP 2144.04(IV)(A).
Regarding Claim 18, Deutsch in view of Yanagawa teaches all of the limitations of Claim 17 (see above). Deutsch teaches the dimensions of the wells are generally less than about 200, 100, 50, 25 or even 10 microns (microcontainer to have a diameter between about 100 µm and 150 µm). By dimensions is meant the usual meaning of the word and is dependent on the shape of the well, for example, for hexagonal or circular wells, the term dimension refers to diameter (para 139) and Yanagawa teaches the cell chamber depth to vary between 50 and 400 µm and the dimensions and overall size will vary depending upon the expected size of the organoid (para 64). Deutsch further teaches the size of the wells of a device is changeable (para 115).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the depth of the microcontainer of Deutsch to fit the size of the liver organoid as taught by Yanagawa. One would have been motivated to make this modification as it would allow the accommodation of the organoid and a change in size or shape has been held prima facie obvious. See MPEP 2144.04(IV)(A).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Deutsch et al. (US20060240548A1) in view of Yanagawa et al. (US20160361466A1) and further in view of Paganelli et al. (US20190284535A1).
Deutsch in view of Yanagawa teaches all of the limitations of Claim 18 (see above). Deutsch in view of Yanagawa does not explicitly teach the lid to be in direct contact with the culture medium containing cells once loaded with the culture medium and cells.
Paganelli teaches the first biocompatible polymer is in physical contact with the cell of the liver organoids (para 36). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the lid be in direct contact with the culture medium containing cells as Paganelli teaches the polymer (the lid of Deutsch in view of Yanagawa) to be in physical contact with the organoid and it would have resulted in an effective system for the growth of liver organoids as taught by Paganelli.
Further, given the culture medium containing cells is not a positively recited limitation of the claim, the device of Deutsch in view of Yanagawa would only need to be capable of coming into direct contact with the culturing medium, and as the device of Deutsch in view of Yanagawa would be capable of being in direct contact with the culturing medium containing cells once loaded, it would meet the claim.
Response to Arguments
Applicant’s arguments with respect to claim 14 has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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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.
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/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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