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 .
Notes
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
It should be noted that this application has been transferred to another examiner.
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.
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.
Claims 1-4, 6-11 and 21 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 recites the limitation "the object" in line 5. There is insufficient antecedent basis for this limitation in the claim. Independent claims 9 and 21 are rejected for the same reason above. Claims 2-4, 6-8, 10-11 and 20 are included in the rejection by virtue of their dependency upon a rejected base claim.
Claim 4 recites the limitation "the bottom of the container is free of the structured surface" in lines 2-3. However, claim 1 requires that the structured surface is arranged at the bottom of the container. Further clarification is requested, and appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6, 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al (US 4,912,048; hereinafter “Smith”) in view of Fry (US 6,150,159).
Regarding claims 1 and 20, Smith discloses a device for generation of 3D cell aggregates from seeding cells, comprising: a container (FIGS. 5-6: cylindrical container (70)) having a wall (86), a bottom (72)and a lid (84) together forming a cavity of the container, said container is formed to have a symmetry rotation axis located within the object itself (cylindrical container that is rotated about its longitudinal axis; col. 4, ll. 24-25 and 42-46); a structured surface within the cavity, wherein the structured surface is arranged at the wall, at the bottom, or at the lid of the container, wherein the structured surface is able to receive cells (flutes (90); col. 4, ll. 32-42), and wherein the structured surface is at least one of biologically inert and nonadhesive to cells (col. 5, ll. 26-30). Regarding the limitation “wherein a rotation around the rotation axis exerts a g-force in a direction of the structured surface in a way that exertion of the g-force to cells loaded into the container causes a sedimentation of the cells in the structured surface,” Smith discloses all of the structural features of the claimed device, and thus the device of Smith is fully capable to function as recited. Smith discloses wherein the container further comprises a port to load the container with medium or cell suspension (port defined by opening (82)), but does not explicitly disclose a second port formed in the bottom of the container, and wherein the port is formed in the lid of the container. Fry discloses a device comprising a container (FIG. 7), a lid (37), two ports (FIG. 7). One of the two ports is formed in the lid of the container, and another of the two ports is formed in the bottom of the container (FIG. 7). In view of Fry, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Smith with the device of Fry to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because Fry discloses that the container can have a single port or multiple ports for introducing and removing materials into and from the container (see FIGS. 3 and 7).
Regarding claim 2, modified Smith further discloses wherein the structured surface comprises a hydrogel and/or wherein the structured surface comprises micro wells for receiving cells (FIG. 6: recessions between ribs (92)).
Regarding claim 3, modified Smith further discloses wherein the structured surface supports a scaffold-free formation of 3D cell aggregates (Smith does not require a scaffold for culturing cells).
Regarding claim 4, modified Smith further discloses wherein the structured surface is arranged such that the bottom of the container is free of the structured surface (structures in the container of Smith formed on the sides of the container; see FGS. 5-6).
Regarding claim 6, modified Smith further discloses wherein the structured surface is arranged essentially parallel to the rotation axis (see FIG. 5).
Regarding claim 8, modified Smith further discloses wherein the container is symmetrical with respect to the rotation axis, and wherein the container comprises at least one of the following features: the wall of the container is curved (FIGS. 5-6; col. 4, ll. 24-25); the structured surface is curved (FIGS. 5-6; col. 4, ll. 24-25); the container is cylindrical (col. 4, ll. 24-25).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 4,912,048) in view of Fry (US 6,150,159) and Schwarz et al. (US 5,437,998; hereinafter “Schwarz”).
Regarding claim 9, modified Smith discloses the device of claim 1 as set forth above. Modified Smith does not explicitly disclose a plurality of said device and an adaptor, wherein the adaptor connects the first device to the second device. Schwarz discloses a plurality of devices for cell culture (FIG. 6: bioreactors (2)), and an adaptor for connecting said plurality of devices (FIG. 6: means (52)). In view of Schwarz, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the device of modified Smith and connecting the devices together by an adaptor as disclosed by Schwarz (FIG. 6). One of ordinary skill in the art would have made said modification for the purpose of increasing the cell culture throughput. Further, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the device of modified Smith, since it has been held that a mere duplication of working parts of a device involves only routine skill in the art (MPEP § 2144.04 VI. B.). One would have been motivated to have duplicated the device of modified Smith for the purpose of increasing the throughput of device of Smith.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Fry as applied to claim 1 above, and further in view of Thomsen et al (WO 2014/072432-A1; hereinafter “Thomsen”).
Regarding claim 10, modified Smith discloses the device according to claim 1 as set forth above. Modified Smith further discloses wherein the structured surface comprises a surface, at least a first recession and a second recession for receiving cells for generating and cultivating cell aggregates, wherein the first and the second recessions are spatially separated (see FIG. 6: recessions between structures). Modified Smith does not explicitly disclose wherein the surface between the first and the second recession is a sloped surface and wherein the first and the second recessions comprise an upper part and a bottom part wherein the upper part has the shape of a truncated cone with an opening angle of 12° to 60° and a ratio of a depth of the upper part to a diameter of the widest end of the upper part is at least 1.5 : 1. Thomsen discloses a device comprising structured surface comprises a surface, at least a first recession and a second recession for receiving cells for generating and cultivating cell aggregates, wherein the first and the second recessions are spatially separated, wherein the surface between the first and the second recession is a sloped surface and wherein the first and the second recessions comprise an upper part and a bottom part wherein the upper part has the shape of a truncated cone with an opening angle of 12° to 60° and a ratio of a depth of the upper part to a diameter of the widest end of the upper part is at least 1.5 : 1 (see [0020]-[0031]). In view of Thomsen, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the structure of modified Smith with the structure of Thomsen to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have resulted in a device having the added advantage of allowing cells to flow more easily into the recessions and preventing the cells to remain between the recessions, and thereby enhance cell culture process (see [0020]-[0031], [0047], [0049]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Fry as applied to claim 1 above.
Regarding claim 11, modified Smith discloses the device according to claim 1 as set forth above. Modified Smith does not explicitly disclose wherein the structured surface is removably positioned at the inner surface of the container. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the structured surface of modified Smith to be removable from the inner surface of the container, since it has been held that constructing formerly integral structure in various elements involves only routing skill in art. One would have been motivated to make the elements separable for the purpose of ease of access, removal and introduction of the cells being cultured.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 4,912,048) in view of Fry (US 6,150,159) and Schwarz (US 5,437,998;).
Regarding claim 21, modified Smith discloses the device of claim 1 as set forth above. Modified Smith does not explicitly disclose wherein the structured surface for receiving the cells is a cartridge that is mountable in the container. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the structured surface of modified Smith to be removable from the inner surface of the container, since it has been held that constructing formerly integral structure in various elements involves only routing skill in art. One would have been motivated to make the elements separable for the purpose of ease of access, removal and introduction of the cells being cultured.
Allowable Subject Matter
Claim 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 8-11 and 19-20 have been considered but are moot in view of the new ground of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
