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All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 102
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)(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, 6-9 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chung et al. (already of record, US 2014/0302594; hereinafter “Chung”).
Regarding claim 1, Chung discloses a device for vascularising a cell aggregate, the device comprising: a matrix region configured to contain a gel-like matrix and the matrix region having at least one opening for positioning the cell aggregate therein based on a desired three-dimensional spatial location (FIGS. 1-2 and 3a-3b: scaffold channel (20) having at least one inlet (22) for introducing scaffold (50) into the scaffold channel; [0036]-[0039]); and one or more fluidic regions configured to contain a supporting fluid that is capable of supporting vascularisation of the cell aggregate, the one or more fluidic regions being in fluid
communication with the matrix region (FIGS. 1-2 and 3a-3b: microfluidic channels (30) disposed at both sides of the scaffold channel (20); [0037]), wherein a flow passage from the one or more fluidic regions to a gel-like matrix disposed in the matrix region is configured to allow three-dimensional vascularisation around the cell aggregate and perfusion of the vasculature once formed (FIGS. 2 and 3a-3b: flow passages defined between the scaffold channel (20) and microfluidic channels (30)); wherein the flow passage is free from intervening structural obstacles disposed between the one or more fluidic regions and the matrix region (see FIGS. 3a-3b: flow path is defined between the part (40) and floor of the device, which is free from obstacles).
Furthermore, it is noted that the recitations of functional language "e.g., for vascularising a cell aggregate; for positioning the cell aggregate therein based on a desired three-dimensional spatial location; and, to contain a supporting fluid" are drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed device and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 2, Chung further discloses wherein the one or more fluidic regions comprise at least two fluidic regions (FIGS. 1-2 and 3a-3b: microfluidic channels (30) disposed at both sides of the scaffold channel (20); [0037]).
Regarding claim 3, Chung further discloses wherein one fluidic region of the one or more fluidic regions is disposed lateral to the matrix region on one side and another fluidic region of the one or more fluidic regions is disposed lateral to the matrix region on the opposite side (FIGS. 1-2 and 3a-3b: microfluidic channels (30) disposed at both sides of the scaffold channel (20); [0037]).
Regarding claim 6, Chung further discloses wherein each fluidic region of the one or more fluid regions comprises at least two openings for facilitating introduction of the supporting fluid in each of the fluidic region (FIG. 1: ports (32,34) coupled to each of the microfluidic channels (30); [0038]).
Regarding claim 7, Chung further discloses wherein the matrix region is substantially symmetrical in shape along its longitudinal length (see FIGS. 1-2).
Regarding claim 8, Chung further discloses wherein the at least two fluidic regions are symmetrically disposed about the matrix region (see FIGS. 1-2).
Regarding claim 9, Chung further discloses a gel-like matrix disposed within the matrix region ([0039]-[0040]).
Regarding claim 12, Chung further discloses wherein the at least two fluidic regions are separated from one another by the matrix region (FIG. 1).
Therefore, Chung meets and anticipates the limitations set forth in claims 1-3, 6-9 and 12.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chung as applied to claim 1 above, and further in view of Nashimoto et al. (already of record, "Perfusable Vascular Network with a Tissue Model in Microfluidic Device," Journal of Visualized Experiments, April 4, 2018, 134: e57242: 12 pages) (hereinafter “Nashimoto”).
Regarding claim 5, Chung discloses the device according to claim 1 as set forth above. Chung does not explicitly disclose wherein the at least one opening is positioned substantially central to the matrix region. Nashimoto discloses a device comprising a central compartment (FIGS. 1a-b: central channel (2)) and one or more fluidic regions in communication with the central compartment (channels (1,3)). The central compartment includes at least one opening that is positioned substantially central to the central compartment and two additional ports (FIG. 1a; page 5). In view of Nashimoto, 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 Chung with the device of Nashimoto such that at least one opening is positioned substantially central to the matrix region. 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 expelling excess amount of gel in the matrix region as disclosed by Nashimoto (page 5).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Chung as applied to claim 1 above, and further in view of Hung et al (already of record, US 2012/0003732; hereinafter “Hung”).
Regarding claim 10, Chung discloses the device according to claim 1 as set forth above. Chung does not explicitly disclose wherein at least part of walls defining the matrix region and the one or more fluidic regions comprises an elastomer. Hung discloses that it is well known in the art to fabricate microfluidic systems from elastomeric materials ([0097]). In view of Hung, 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 substituted that material of the device of Chung with the elastomer material as disclosed by Hung to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known material for another for the predictable result of fabricating microfluidic devices. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Chung as applied to claim 1 above, and further in view of Hung (already of record, US 2012/0003732).
Regarding claim 11, Chung discloses the device according to claim 1 as set forth above. Chung discloses wherein the device comprises a substrate comprising a first portion having patterns formed on a surface thereof (see FIGS. 3a-3b), and a second portion adapted to cover the surface comprising the patterns (see FIGS. 3a-3b). Chung does not explicitly disclose wherein the first portion of the device is an elastomer. Hung discloses that it is well known in the art to fabricate microfluidic systems from elastomeric materials ([0097]). In view of Hung, 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 substituted that material of the first portion of the device of Chung with the elastomer material as disclosed by Hung to arrive at the claimed invention. one of ordinary skill in the art would have made said modification because Chung discloses that it is well known in the art to fabricate microfluidic systems from elastomeric materials ([0097]). Further, one of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known material for another for the predictable result of fabricating microfluidic devices. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Chung as applied to claim 1 above.
Regarding claim 13, Chung discloses the device according to claim 1 as set forth above. Chung discloses a chip comprising at least one device according to claim 1 but does not explicitly disclose wherein the chip comprises a plurality of the device according to claim 1. 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 duplicated the device of Chung, 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 duplicate the device of Chung for the purpose of increasing the throughput of the assay performed by the system of Chung.
Response to Arguments
Applicant's arguments filed on July 20, 2026, have been fully considered but they are not persuasive.
In response to the Applicant’s argument that Chung fails to disclose a flow passage that is free from intervening structural obstacles (see Remarks, pages 7 to 8), Applicant’s argument is noted but it is not persuasive. The claims as currently presented do not require the fluidic region and the matrix region to be free of obstacles. Rather, the claims require a flow passage from one or more fluidic regions to be free from intervening structural obstacles. As discussed in the rejection, the flow passage of Chung connecting one fluidic region and matrix region is defined between the part (40) and floor of the flow passage. The flow passage itself does not contain any intervening structural obstacles.
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 LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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