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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/05/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
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 1-7, 11, and 17 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 astrocyte supply part" in the last line. There is insufficient antecedent basis for this limitation in the claim. The prior lines of the claim recite “astrocyte supply part” (line 6) and “two sets of astrocyte supply parts” (fourth to last line) and it is unclear which one of these is meant by “the astrocyte supply part”.
Regarding claim 2, the claim recites “the astrocyte chamber” in line 2. It is noted that claim 1, from which claim 2 depends, recites that the chip comprises “astrocyte supply part, comprising…astrocyte chamber” (lines 6-7), and “wherein two sets of astrocyte supply parts are respectively provided” (fourth to last line). The fourth to last line of claim 1 can be reasonably interpreted as meaning two sets of astrocyte supply parts that are the same as the astrocyte supply part defined in lines 6-7, or as meaning two astrocyte supply parts that are unrelated to the astrocyte supply part defined in lines 6-7. In the case of the first interpretation, then the chip according to claim 2 would comprise multiple astrocyte chambers, and therefore antecedent basis is lacking for the limitation “the astrocyte chamber”.
Similarly, claim 2 recites the limitation “the culture medium channel” in line 4. Claim 1, from which claim 2 depends, recites that the chip comprises “a culture medium supply part, comprising…a culture medium channel” (lines 3-5) and “wherein two sets of culture medium supply parts are respectively provided” (second to last line). The second to last line of claim 1 can be reasonably interpreted as meaning two sets of culture medium supply parts that are the same as the culture medium supply part defined in lines 3-5, or two sets of culture medium supply parts that are unrelated to the culture medium supply part defined in lines 3-5. In the case of the first interpretation, then the chip according to claim 2 would comprise multiple culture medium channels, and therefore antecedent basis is lacking for the limitation “the culture medium channel”.
Claim 3 recites “the culture medium channel” and is rejected for the same rationale applied to claim 2, above.
Claim 4 recites “the culture medium channel” and is rejected for the same rationale applied to claim 2, above.
Claim 5 recites “the astrocyte chamber” and is rejected for the same rationale applied to claim 2, above.
Claim 5 recites “the culture medium channel” and is rejected for the same rationale applied to claim 2, above.
Claim 11 recites “the astrocyte chamber” and is rejected for the same rationale applied to claim 2, above.
Claim 11 recites “the culture medium channel” and is rejected for the same rationale applied to claim 2, above.
Dependent claims are rejected for the same reason(s) as the base claim(s) upon which they depend.
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 1-3, 5-7, 11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Uzel et al. (Microfluidic device for the formation of optically excitable, three-dimensional, compartmentalized motor units) in view of Novak et al. (US Patent Application Publication 2017/0022464) (already of record).
Regarding claim 1, Uzel et al. discloses a biomimetic nerve chip (Abstract) (Fig. 3, p. 4) for evaluating a drug response (p. 4 col. 2 para. 1-p. 5 col. 1 para. 1) (thus, the device is fully capable of evaluating efficacy and toxicity of a drug), the biomimetic nerve chip comprising:
a culture medium supply part (p. 3 col. 2 para. 2, p. 9 col. 1 para. 4) (Fig. 3, p. 4), comprising:
two culture medium storage chambers (p. 3 col. 2 para. 2, p. 9 col. 1 para. 4) (Fig. 3, p. 4), and
a culture medium channel communicating with each of the chambers (p. 3 col. 2 para. 2, p. 9 col. 1 para. 4) (Fig. 3, p. 4);
a cell supply part (p. 3 col. 2 para. 2-p. 4 col. 2 para. 1, p. 9 col. 1 para. 4) (Fig. 3, p. 4) (reads on an astrocyte supply part as will be discussed below), comprising:
a cell inlet, cell outlet, and cell chamber (see “leftmost channel” and two ports at either end thereof, p. 3 col. 2 para. 2-p. 4 col. 2 para. 1, p. 9 col. 1 para. 4) (Figs. 3-4, pp. 4-5) (note: the cell chamber is a 0.5 mm channel that receives neurospheres therein via the ports, see p. 3 col. 2 para. 2, and thus the aforementioned structures are fully capable of operating as an astrocyte inlet, astrocyte outlet, and astrocyte chamber, and will hereinafter be referred to as such),
wherein the astrocyte chamber has two ends (Figs. 3-4, pp. 4-5),
wherein the astrocyte inlet is provided at one end of the astrocyte chamber (Figs. 3-4, pp. 4-5),
wherein the astrocyte outlet is provided at the other end of the chamber (Figs. 3-4, pp. 4-5),
wherein the astrocyte chamber is provided between the astrocyte inlet and the astrocyte outlet and extended in the same direction as the culture medium channel to be joined with a portion of the culture medium channel (p. 3 col. 2 para. 2-p. 4 col. 2 para. 1) (Figs. 3-4, pp. 4-5), wherein a first mixing region for cross-communication of the a culture medium is formed in a joining portion between the astrocyte chamber and the culture medium channel (p. 3 col. 2 para. 2-p. 4 col. 2 para. 1) (Figs. 3-4, pp. 4-5), and
astrocyte channels provided to communicate between one end of the astrocyte chamber and the astrocyte inlet and between the other end of the astrocyte chamber and the astrocyte outlet, respectively (see channels communicating between each of the two ports and the 0.5 mm channel, Figs. 3-4, pp. 4-5); and
a neuron supply part (comprising “middle channel”; receives portion of neurons and thus reads on a neuron supply part) (channel (p. 3 col. 2 para. 2-p. 5 col. 1 para. 1) (Figs. 3-4, pp. 4-5), comprising:
a neuron inlet, a neuron outlet, and a neuron outlet (see “middle channel” and two ports at either end thereof, p. 3 col. 2 para. 2-p. 4 col. 2 para. 1, p. 9 col. 1 para. 4) (Figs. 3-4, pp. 4-5) (note: the two ports read on a neuron inlet and neuron outlet, respectively, as they are ports communicating with a region receiving a portion of a neuron as discussed above),
wherein the neuron chamber has two ends (Figs. 3-4, pp. 4-5),
wherein the neuron inlet is provided at one end of the neuron chamber (Figs. 3-4, pp. 4-5),
wherein the neuron outlet is provided at the other end of the neuron chamber (Figs. 3-4, pp. 4-5),
wherein the neuron chamber is provided between the neuron inlet and the neuron outlet and extended in the same direction as the astrocyte chamber to be joined with a portion of the astrocyte chamber (p. 3 col. 2 para. 2-p. 5 col. 1 para. 1) (Figs. 3-4, pp. 4-5), wherein a second mixing region for cross-communication of a culture medium is formed in a joining portion between the neuron chamber and the astrocyte chamber (p. 3 col. 2 para. 2-p. 5 col. 1 para. 1) (Figs. 3-4, pp. 4-5), and
neuron channels provided to communicate between one end of the neuron chamber and the neuron inlet and between the other end of the neuron chamber and the neuron outlet (see channels communicating between each of the two ports and the main region of the middle channel comprising the neuron portion, Figs. 3-4, pp. 4-5); wherein the first mixing region is composed of a portion of the culture medium channel, a portion of the astrocyte chamber joined with the portion of the culture medium channel, and partial block members (called posts) formed in the joining portion (p. 3 col. 2 para. 2-p. 5 col. 1 para. 1) (Figs. 3-4, pp. 4-5);
wherein the second mixing region is composed of a portion of the astrocyte chamber, a portion of the neuron chamber joined with the portion of the astrocyte chamber, and partial block members (called posts) formed in the joining portion (p. 3 col. 2 para. 2-p. 5 col. 1 para. 1) (Figs. 3-4, pp. 4-5);
wherein the partial block members are micro-post structures separated from each other and arranged in a line (“row of posts”) in a direction of extension of the culture medium channel, the astrocyte chamber, and the neuron chamber (p. 3 col. 2 para. 2-p. 5 col. 1 para. 1) (Figs. 3-4, pp. 4-5), wherein the arrangement of micro-post structures forms bottleneck-structured movement passages between the culture medium channel, the astrocyte chamber, and the neuron chamber (p. 3 col. 2 para. 2-p. 5 col. 1 para. 1) (Figs. 3-4, pp. 4-5), wherein two sets of astrocyte supply parts are respectively provided above and below the neuron supply part (see the first astrocyte supply part discussed above and additionally the “right channel”; thus two parts are provided on either side of the “middle” neuron channel which fulfills the claim limitation of “above and below the neuron supply part” depending on the orientation of the device; each of the left and right channels read on being an astrocyte supply part as each of the left and right channels are at least 0.5 mm wide cell channels which would be fully capable of receiving astrocytes, see p. 3 col. 2 para. 2-p. 5 col. 1 para. 1 and Figs. 3-4, pp. 4-5); and
wherein two sets of culture medium supply parts are respectively provided so as to “flank” the “left”, “middle”, and “right” cell channels (reads on two sets of culture medium supply parts being provided “above and below” one or more astrocyte supply parts) (p. 3 col. 2 para. 2-p. 5 col. 1 para. 1) (Figs. 3-4, pp. 4-5).
Uzel et al. is silent as to wherein the micro-post structures have a vertically long hexagonal shape; however Uzel et al. discloses that during use the micro-post structures may be used to constrain a gel while allowing cell-cell signaling and nutrient supply (p. 4 col. 1 para. 1).
Novak et al. discloses a biomimetic chip (para. 55-56) comprising a first chamber (130) and a second chamber (132) divided by an arrangement of spaced apart micro-posts (124) (para. 68-69) (Figs. 1a-1c) such that the micro-posts constrain a fluid such as a gel within one or more of the chambers (para. 73, 81). Novak et al. further discloses forming the micro-post structures so as to have a hexagonal shape because “it has been found that the shape of a hexagon provides better contact angles for surface tension of fluids (e.g., liquids, gels, etc.) to constrain the fluids by the posts” (para. 73). Additionally, Novak et al. discloses that each micro-post structure is taller than it is wide (para. 70, 73), and that the arrangement of micro-posts forms bottleneck-structured movement passages between the chambers (Fig. 1c, sheet 2 of 16).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the micro-post arrangement disclosed by Uzel et al. such that the micro-post structure are a vertically long (i.e., each micro-post is taller than it is wide) hexagonal shape wherein the arrangement of hexagonal micro-post structures forms bottleneck-structured movement passages between the chambers and the channels, as Novak et al. discloses that this particular shape and arrangement was known in the art to be effective for constraining a gel within a chamber on a biomimetic chip, and the skilled artisan would have been motivated to select a particular configuration recognized in the art to be effective for confining gel regions, as envisioned by Uzel et al.
Regarding claim 2, Uzel et al. discloses wherein the culture medium storage chambers store therein a culture medium to be supplied to the astrocyte chamber (comprising “leftmost channel” as set forth above) and the neuron chamber through the first and second mixing regions and serve to supply the stored culture medium to neurons through the culture medium channel and the astrocyte chamber (p. 3 col. 2 para. 2-p. 5 col. 1 para. 1) (Figs. 3-4, pp. 4-5).
Regarding claim 3, Uzel et al. discloses wherein the culture medium channel serves as a main flow passage of a culture medium wherein the culture medium flows between the two culture medium storage chambers (p. 3 col. 2 para. 2) (Figs. 3-4, pp. 4-5).
Regarding claim 5, Uzel et al. discloses wherein the astrocyte chamber (“leftmost channel”) stores, fixes, and cultures therein a mixture of cells and Matrigel (reads on an auxiliary component supplied through the astrocyte inlet (p. 3 col. 2 para. 2, p. 6 col. 1 para. 1) (Figs. 3-4, pp. 4-5), serves as a culture container in which the fixed cells are cultured (Abstract, p. 3 col. 2 para. 2, p. 6 col. 1 para. 1) (Figs. 3-4, pp. 4-5), and serves as a passage through which culture medium introduced through the culture medium channel is delivered to neurons fixed in the neuron chamber and various metabolites and wastes secreted from the neurons are drained to the outside of the neuron chamber (Abstract, p. 3 col. 2 para. 2-p. 6 col. 1 para. 1) (Figs. 3-4, pp. 4-5).
As to the limitation of the cells being astrocytes, this is a recitation of intended use of the chip and has therefore been given appropriate patentable weight (see MPEP 2114). The structure disclosed by Uzel et al. is fully capable of operating such that the cells are astrocytes, as discussed in the rejection of claim 1, above, and therefore this limitation does not introduce a patentable distinction over the prior art.
Regarding claim 6, Uzel et al. discloses wherein the neuron chamber (“middle chamber”) stores, fixes, and cultures therein a mixture of a neuronal components and Matrigel (reads on an auxiliary component supplied through the neuron inlet and serves as a culture container in which the fixed neurons are cultured (p. 3 col. 2 para. 2-p. 6 col. 1 para. 1) (Figs. 3-4, pp. 4-5).
Regarding claim 7, Uzel et al. discloses wherein the auxiliary component is Matrigel, as set forth above.
Regarding claim 11, Uzel et al. discloses wherein the micro-post structures allow cross-communication of a culture medium, through the separated regions thereof, between the portion of the culture medium channel and the portion of the astrocyte chamber joining with the portion of the culture medium channel and between the portion of the astrocyte chamber and the portion of the neuron chamber joining with the portion of the astrocyte chamber (p. 3 col. 2 para. 2-p. 6 col. 1 para. 1) (Figs. 3-4, pp. 4-5).
Regarding claim 17, Uzel et al. discloses wherein the auxiliary component is Matrigel, as set forth above.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Uzel et al. (Microfluidic device for the formation of optically excitable, three-dimensional, compartmentalized motor units) in view of Novak et al. (US Patent Application Publication 2017/0022464) (already of record) as applied to claim 1, above, and in further view of Osaki et al. (Crosstalk between developing vasculature and optogenetically engineered skeletal muscle improves muscle contraction and angiogenesis).
Regarding claim 4, Uzel et al. discloses the culture medium channel, as set forth above, and further discloses wherein the culture medium channel communicates with neighboring channels, such as a channel containing muscle cells (p. 3 col. 2 para. 2-p. 4 col. 1 para. 1) (Figs. 3-4, pp. 4-5).
Uzel et al. is silent as to wherein an inner surface of the culture medium channel is coated with vascular endothelial cells.
Osaki et al. discloses that crosstalk between vasculature and muscle is important to the physiological function of muscle (Title, abstract) and to this end Osaki et al. discloses providing vascular endothelial cells and muscle cells within a microfluidic device to study their interaction (p. 66 col. 1 para. 3-col. 2 para. 2, p. 73 col. 1 last paragraph) (Fig. 1, p. 66).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the culture medium channel disclosed by Uzel et al. to be coated with vascular endothelial cells, based on the teachings of Osaki et al., to provide for crosstalk between vascular endothelial cells and other cell types within the device to improve physiological modeling.
Conclusion
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799