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 .
Response to Arguments and Amendments
Claims 3-5, 7, and 16-17 have been canceled in the claim amendments dated 9/2/2026.
The amended specification filed 9/2/2026 have overcome the objection to the specification presented in the prior Office Action.
The claim amendments dated 9/2/2026 have overcome the rejections under 35 U.S.C. 112(b) and 35 U.S.C. 112(a) presented in the prior Office Action. However, a new rejection under 35 U.S.C. 112(b) is presented below.
Applicant’s arguments with respect to claims 1-2, 6, 8-15, and 18-20 filed 9/2/2026 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Claim Objections
Claims 10 and 14 are objected to because of the following informalities:
In claim 10, the phrase “epithelial-to-mesenchmyal” appears to be a typographical error and should read “epithelial-to-mesenchymal”
In claim 14, each instance of “pm” appear to be a typographical error and should read “µm”.
Appropriate correction is required.
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 18 and 19 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 18, it is unclear if the biologically derived hydrogel scaffold is the same or different as the biologically derived hydrogel scaffold recited in claim 12 (which claim 18 depends upon).
Claim 19 is similarly rejected as it depends upon rejected claim 18.
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.
Claims 1-2, 6, 8-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Redaelli et al. (US 2018/0105782 A1) (hereinafter referred to as Redaelli, previously presented) in view of Goyal et al. (US 2020/0270557 A1) (hereinafter referred to as Goyal).
Regarding claim 1, Redaelli discloses a medical device (abstract; [0011]) comprising:
a first compartmentalized microfluidic channel flanked by two microfluidic chambers (Fig. 1a – see annotated figure below), wherein the two microfluidic chambers are separated from the first compartmentalized microfluidic channel by a plurality of micropillars (Fig. 1, confinement means 2; [0187] describes supporting means as micropillars), and;
a second compartmentalized microfluidic channel, wherein the first and second compartmentalized microfluidic channels are situated vertically relative to one another (Fig. 1); and
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a membrane situated between the first and second compartmentalized microfluidic channels (Fig. 1; membrane 3; [0208]).
Redaelli does not explicitly disclose or teach wherein the two microfluidic chambers comprising a biologically derived hydrogel scaffold, the first compartmentalized microfluidic channel comprising cancer cells, the second compartmentalized microfluidic channel comprising blood vessel-mimicking endothelium, or wherein the membrane is porous.
However, Redaelli teaches that cell matrices made of biologically derived hydrogel used within microfluidic channels ([0112]-[0115], and [0116]) provide a culturing environment for cells ([0107]-[0108] and [0280]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Redaelli’s two microfluidic chambers to further comprise a biologically derived hydrogel scaffold to provide a culturing environment for cells, as taught by Redaelli. It has been held that it is prima facie obvious to applying a known technique to a known devices ready for improvement to yield predictable results (MPEP § 2143 I D). In this case, Redaelli’s device (the base device) could be improved by adding a biologically derived hydrogel scaffold in the two microfluidic chambers (known technique), which would predictably provide a culturing environment for cells.
Goyal in the analogous art of biomimetic devices teaches that it is well known in the art to use a biomimetic device comprising microfluidic channels separated by a porous membrane (Fig. 4) to mimic a tumoral environment ([0181]) by growing cancer cells in one microfluidic channel and a blood vessel-mimicking endothelium in the other microfluidic channel (Fig. 4; [0173] describes endothelium as a mimicking a blood vessel). Goyal also teaches that a porous membrane allows cells to migrate between the channels ([0184]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Redaelli’s device such that the first compartmentalized microfluidic channel comprises cancer cells, the second compartmentalized microfluidic channel comprises blood vessel-mimicking endothelium, and wherein the membrane is porous because Goyal teaches that such features are known in the art to mimic a tumoral environment. The ordinarily skilled artisan would be motivated to study a tumoral environment in vitro.
Regarding claim 2, the prior art combination teaches the medical device of claim 1, wherein the first and second compartmentalized microfluidic channels are in fluid communication such that cells can migrate from the first compartmentalized microfluidic channel to the second compartmentalized microfluidic channel through the porous membrane (Goyal: [0184]).
Regarding claim 6, the prior art combination teaches the medical device of claim 1.
The limitation “wherein the biologically derived hydrogel scaffold permit for at least one of time-lapse visualization of perfused platelets and blood immune cells within a vessel, their extravasation through an endothelium, or consequential cancer cell invasiveness” is directed toward the intended manner of operating the claimed biologically derived hydrogel scaffold and does not differentiate the claimed biologically derived hydrogel scaffold from the prior art biologically derived hydrogel scaffold because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art combination biologically derived hydrogel scaffold would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 8, the prior art combination teaches the medical device of claim 1, wherein the plurality of micropillars are at a set distance (Redaelli: Fig. 1a).
The limitation “to facilitate formation of a solid-liquid interface” is directed toward the intended manner of operating the claimed plurality of micropillars and does not differentiate the claimed structure from the prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art combination micropillars would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 9, the prior art combination teaches the medical device of claim 8.
The limitation “wherein the solid-liquid interface facilitates in two-dimensional monolayers of tumor cells assuming a three-dimensional morphology” is directed toward the intended use of the micropillars (see claim 8 rejection above). In the absence of further positively recited structure, the prior art applied to claim 8 above meets claim 9.
Regarding claim 10, the prior art combination teaches the medical device of claim 9.
The limitation “wherein the three-dimensional morphology is assumed after undergoing epithelial-to-mesenchymal transition (EMT)” is directed toward the intended use of the micropillars (see claims 8 and 9 rejection above). In the absence of further positively recited structure, the prior art applied in to claim 9 meets claim 10.
Regarding claim 11, the prior art combination teaches the medical device of claim 1.
The limitation “wherein the medical device identifies an antiplatelet therapeutic” is directed toward the intended manner of operating the claimed medical device and does not differentiate the claimed structure from the prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II).
The limitation “wherein the antiplatelet therapeutic is configured for evaluation of an antiplatelet therapeutic on cancer cell invasiveness through the biologically derived hydrogel scaffold” is directed to the intended use of the medical device. In the absence of further positively recited structure, the prior art applied to claim 1 above meets claim 10.
Regarding claim 12, Redaelli discloses an organ-on-chip ([0157], in vitro tissue model) comprising:
a top portion comprising three parallel microchannels, wherein the three parallel microchannels are separated by a plurality of micropillars (Fig. 1a – see annotated figure above, top portion has three microchannels separated by micropillars 5); a bottom portion comprising a fourth microchannel (Fig. 1a); and a membrane between the top portion and the bottom portion (Fig. 1a).
Redaelli does not explicitly disclose or teach a central microchannel of the three parallel microchannels comprising cancer cells, two lateral microchannels of the three parallel microchannels comprising a biologically derived hydrogel scaffold, the fourth microchannel comprises blood vessel-mimicking endothelium.
Goyal teaches a biomimetic device used to mimic tumoral environments, where a central microchannel of three parallel microchannel comprises cancer cells and a fourth microchannel comprising blood vessel-mimicking endothelium (Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Redaelli’s device such that the central microchannel of the three parallel microchannels comprising cancer cells and the fourth microchannel comprises blood vessel-mimicking endothelium for the purpose of mimicking a tumoral environment. It has been held that it is prima facie obvious to use a known technique to improve similar devices in the same way (MPEP § 2143 I C). In this case, Redaelli’s device (the base device) could be improved by culturing cancer cells and endothelium in the manner claimed (known technique), which would predictably allow the device to mimic a tumoral environment.
Redaelli teaches that cell matrices made of biologically derived hydrogel used within microchannels ([0112]-[0115], and [0116]) provide a culturing environment for cells ([0107]-[0108] and [0280]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Redaelli’s lateral microchannels such that they comprise a biologically derived hydrogel scaffold to provide a culturing environment for cells, as taught by Redaelli. It has been held that it is prima facie obvious to applying a known technique to a known devices ready for improvement to yield predictable results (MPEP § 2143 I D). In this case, Redaelli’s device (the base device) could be improved by adding a biologically derived hydrogel scaffold in the lateral microchannels (known technique), which would predictably provide extra culturing environment for cells.
Goyal teaches further that a porous membrane allows cancer cells to migrate between different portions of the device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the prior art combination membrane, as discussed above, to be porous to allow cancer cells to migrate between the top and bottom portion. The ordinarily skilled artisan would be motivated to imitate a tumoral environment.
Regarding claim 13, the prior art combination teaches the organ-on-chip of claim 12, wherein the plurality of micropillars comprises hexagonal micropillars (Redaelli: [0187]).
Regarding claim 14, the prior art combination teaches the organ-on-chip of claim 12, wherein each micropillar has dimensions of 250 µm x 100 µm x 100 µm (length x width x height) (Redaelli: [0050] discloses a height of between 20 and 400 µm, a length and width between 5 µm and 100 µm). The height and width disclosed by Redaelli anticipates the height and width claimed (MPEP § 2131.03).
The prior art combination does not expressly disclose or teach the length as claimed.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the micropillar as such a modification would merely amount to a change in proportion of the micropillar. It has been held that that changes in proportion are not sufficient to patentably distinguish over the prior art (MPEP § 2144.04 IV A). The micropillar of Redaelli would perform the same function of forming the microchannels.
Regarding claim 15, the prior art combination teaches the organ-on-chip of claim 12, wherein each micropillar of the plurality of micropillars is equally spaced apart (Redaelli: [0049])
Regarding claim 18, the prior art combination teaches the organ-on-chip of claim 12, wherein the plurality of micropillars comprises a biologically derived hydrogel scaffold is supported between individual micropillars of the plurality of micropillars to form a solid-liquid interface (Redaelli: [0195], cell matrix, i.e., hydrogel, delimited by confinement means, i.e., micropillars).
The limitation “to form a solid-liquid interface” is directed toward the intended manner of operating the claimed biologically derived hydrogel scaffold and does not differentiate the claimed structure from the prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II).
Regarding claim 19, the prior art combination teaches the organ-on-chip of claim 18.
The limitation “wherein the biologically derived hydrogel scaffold permits for at least one of time-lapse visualization of perfused platelets and blood immune cells within a vessel, their extravasation through an endothelium, or consequential cancer cell invasiveness” is directed toward the intended manner of operating the claimed biologically derived hydrogel scaffold and does not differentiate the claimed structure from the prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art combination biologically derived hydrogel scaffold would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 20, the prior art combination teaches the organ-on-chip of claim 12.
The prior art combination “wherein the organ-on-chip identifies an antiplatelet therapeutic” is directed toward the intended manner of operating the claimed organ-on-chip and does not differentiate the claimed structure from the prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II).
The limitation “wherein the antiplatelet therapeutic is configured for evaluation of an antiplatelet therapeutic on cancer cell invasiveness through the biologically derived hydrogel scaffold” is directed to the intended use of the organ-on-chip. In the absence of further positively recited structure, the prior art applied to claim 12 above meets claim 20.
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.
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/A.J.C./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
