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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13, in the reply filed on March 24, 2026 is acknowledged.
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 1-13 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.
Regarding claim 1, the phrase "gel-like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "gel-like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Claims 2-13 are included in this rejection by virtue of their dependency upon a rejected base claim.
Claim 2 recites the limitation "one or more fluidic regions" in lines 1-2. It is unclear if the one or more fluidic regions are referring to the one or more fluidic regions recited earlier in the claim or are additional elements. It is suggested to amend the claim to recite --- the one or more fluidic regions --.
Claim 3 recites the limitation "one fluidic region" in lines 1-2. It is unclear if the one fluidic region is referring one of the two fluid regions recited earlier in the claim or is an additional fluid region. It is suggested to amend the claim to recite --- one fluidic region of the at last two fluidic regions – for clarity.
The term “substantially” in claims 4-5, 7 and 11 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Appropriate correction is required.
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 1-4, 6-9 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chung et al. (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)).
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 4, Chung further discloses wherein the flow passage is substantially free from intervening structural obstacles disposed between the one or more fluidic regions and the matrix region (see FIGS. 3a-3b).
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 1-4, 6-9 and 12.
Claims 1-4 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vulto et al (already or record, WO 2017/216113-A2; hereinafter "Vulto").
Regarding claim 1, Vulto discloses 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 (see FIGS. 7 to 9: compartment (103) having an opening (100); page 39, line 30 to page 40, line 10); 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. 7 to 9: microfluidic channels (102); page 30, lines 30-32), 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. 7 to 9: flow passages defined between the microfluidic channels (102) and compartment (103); see page 39, line 30 to page 40, line 2).
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, Vulto further discloses wherein one or more fluidic regions comprise at least two fluidic regions (FIG. 8: microchannels (102)).
Regarding claim 3, Vulto further discloses wherein one fluidic region is disposed lateral to the matrix region on one side and another fluidic region is disposed lateral to the matrix region on the opposite side (FIGS. 8 and 26: microchannels (102)).
Regarding claim 4, Vulto further discloses wherein the flow passage is substantially free from intervening structural obstacles disposed between the one or more fluidic regions and the matrix region (see FIGS. 8-9 and 26: no pillars or posts present between the microchannels (102) and compartment (103)).
Regarding claim 6, Vulto further discloses wherein each fluidic region of the one or more fluidic regions comprises at least two openings for facilitating introduction of the supporting fluid in each of the fluidic region (each microchannel (102) is coupled to two reservoirs; page 39, line 30 to page 40, line 2).
Regarding claim 7, Vulto further discloses wherein the matrix region is substantially symmetrical in shape along its longitudinal length (central compartment (103); see FIGS. 7 to 9 and 26; page 30, line 30 to page 40, line 2).
Regarding claim 8, Vulto further discloses wherein the at least two fluidic regions are symmetrically disposed about the matrix region (see FIGS. 7 to 9 and 26).
Regarding claim 9, Vulto further discloses a gel-like matrix disposed within the matrix region (e.g., see page 40, lines 6-8).
Therefore, Vulto meets and anticipates the limitations set forth in claims 1-4 and 6-9.
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 (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).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Vulto as applied to claim 1 above, and further in view of Hung (US 2012/0003732).
Regarding claim 10, Vulto discloses the device according to claim 1 as set forth above. Vulto does not explicitly disclose wherein at least part of walls defining the matrix region and the one or more fluidic regions comprises an elastomer. However, Vulto does disclose wherein at least a portion of the device can be fabricated from silicon rubber material (page 13, line 23-26). 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 Vulto 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).
Regarding claim 11, Vulto discloses the device according to claim 1 as set forth above. Vulto does not explicitly disclose wherein the device comprises an elastomer disposed on a substrate, wherein the elastomer comprises patterns formed on an open surface of the elastomer, the patterns corresponding to a layout of the matrix region and the one or more fluidic regions, and wherein the substrate substantially fluidically seals the patterns at the open surface of the elastomer to form the matrix region and the one or more fluidic regions of the device. However, Vulto does disclose wherein at least a portion of the device can be fabricated from silicon rubber material that is disposed on a base layer (page 13, line 23-26). 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 Vulto 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 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 comprise 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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Vulto as applied to claim 1 above.
Regarding claim 13, Vulto discloses the device according to claim 1 as set forth above. Vulto discloses a chip comprising at least one device according to claim 1, but does not explicitly disclose wherein the chip comprise 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 Vulto, 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 Vulto for the purpose of increasing the throughput of the assay performed by the system of Vulto.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cho et al (US 2014/0273223) disclose a device comprising a central compartment and one or more fluidic regions. Lee (US 2023/0147702) discloses disclose a device comprising a central compartment and one or more fluidic regions. Catarino Ribeiro et al (US 2023/0137145) disclose a device comprising a central compartment and one or more fluidic regions.
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
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