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/Amendments
Applicant’s arguments with respect to claims 1-20 filed 7/21/2026 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
The objections to the claims, specification, and drawings are withdrawn in light of the amended specification and amended claims filed 7/21/2026.
The rejection under 35 U.S.C. 112(b) presented in the previous Office Action are withdrawn in light of the amendments to the claims filed 7/21/2026. However, new findings warrant a new rejection under 35 U.S.C. 112(b) discussed below.
Examiner acknowledges the cancellation of claims 1, 3, and 20 in the amendments to the claims filed 7/21/2026.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 5/8/2026 is in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the 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.
Claim 4 is 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 4, the phrase “stimulates an arterial blood flow” renders the claim indefinite in light of the specification. It is unclear if the term “stimulates” is a typographical error as the specification filed 7/21/2026 recites a device that stimulates an arterial blood flow ([00111]) and a device simulating arterial blood flow ([0010]). Therefore, the claim of note appears inconsistent with the specification (MPEP § 2173.03). Clarification and/or correction is requested.
Claim 5 is similarly rejected as it depends upon rejected claim 4.
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 2, 4-10, 12-19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen et al. (US 2017/0101618 A1) (hereinafter referred to as Kamen, already of record) in view of Vacanti (US Patent 11,534,530 B2) (hereinafter referred to as Vacanti-1, see PTO-892).
Regarding claim 2, Kamen discloses a liquid-tight case ([0154], enclosure 100 with a fluid-tight seal) comprising: a housing (Fig. 3, enclosure 100 coupled with a first inlet port, a second inlet port, and at least one outlet port (Fig. 3, shows multiple fluid lines 1000A-1000D with pass-throughs 1002 and connector 1004 for fluid transfer; [0155] fluid lines may be used for supplying or draining).
Kamen does not disclose or teach a tissue device or the housing enclosing a tissue device, as well as limitations with respect to the tissue device.
However, Vacanti-1 in the analogous art biomimetic structures discloses a tissue device (claim 1, artificial organ), comprising a first channel network (claim 1, plurality of vascular tubes), and a second channel network (claim 1, a plurality of non-vascular tubes), in fluidic communication with the first channel network (claim 1, “interface between the plurality of vascular tubes and the plurality of non-vascular tubes…the interface to allow a degree of fluidic communication between the plurality of vascular tubes and the plurality of non-vascular tubes”).
Kamen discloses that the housing can hold a biological specimen ([0145]) and provides a sterile environment for cultured specimen while maintaining perfusion capabilities ([0154]).
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 liquid-tight case of Kamen to comprise and enclose the tissue device of Vacanti-1 because Kamen’s case would predictably provide a sterile environment for Vacanti-1’s tissue device while maintaining perfusion capabilities.
Furthermore, 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 prior art combination ports and channels in the manner claimed in claim 2 to perfuse liquid through the tissue device, and the ordinarily skilled artisan would be motivated to seed the tissue device with cells without compromising sterility.
Regarding claim 4, the prior art combination teaches the liquid-tight case of claim 2.
The incorporation of Vacanti-1’s tissue device meets the limitation wherein the tissue device is a device that stimulates an arterial blood flow, as well as subsequent limitations with respect to the tissue device absent clear evidence to the contrary because Applicant admits in [00112] of the specification filed 7/21/2026 that Vacanti-1’s tissue device is a suitable tissue device for the claimed invention. Note: the pre-grant publication of Vacanti-1 is US 2018/0236134 A1.
Regarding claim 5, the prior art combination teaches the liquid-tight case of claim 4, wherein the tissue device is a liver device, as set forth above.
Regarding claim 6, the prior art combination teaches the liquid-tight case of claim 2.
The prior art combination discloses wherein the at least one outlet port comprises a first outlet port in fluidic communication with the first inlet port through the tissue device, as set forth above (see claim 2 rejection under 35 U.S.C. 103).
Regarding claim 7, the prior art combination teaches the liquid-tight case of claim 2.
Kamen of the prior art combination discloses wherein the housing comprises: a base formed with a hollow space (Fig. 5, second part 100D) configured to house the tissue device; a lid coupled with the base (Fig. 5, first part 100C) to enclose the tissue device within the hollow space; and a seal disposed between the base and the lid ([0162]; Fig. 10, sealing surface 25 between 100B and 100A) to enhance sealing of the liquid-tight case.
The limitations “configured to house the tissue device”, “to enclose the tissue device within the hollow space”, “to enhance sealing of the liquid-tight case” are directed toward the intended manner of operating the claimed hollow space, lid, and seal and do not differentiate the claimed structures from corresponding prior art structures because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art combination hollow space 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 liquid-tight case of claim 7.
The prior art combination does not explicitly disclose or teach the claimed materials used to couple the lid to the base.
Kamen of the prior art combination discloses heat bonding, laser welding, ultrasonic welding, solvent bonding, or any other suitable attachment processes to couple the lid to the base ([0158]).
Kamen further discloses it is known in the art to use fasteners ([0338]), snap-fitting (last sentence of [0390]), and adhesives ([0250]) to connect or couple two components together.
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 manner in which the prior art combination lid and base are coupled to use fasteners, snap-fitting, adhesives, or a combination thereof because such a modification would amount to a simple substitution of components. It has been held that a claim has no patentable significance when substitution of one known element for another yields predictable results to one of ordinary skill in the art (MPEP § 2143 B). In this case, using fasteners, snap-fitting, adhesives, or a combination thereof would predictably couple the lid to the base, as shown by Kamen.
Regarding the limitations with respect to coupling the base “press-fitting” and “tape”, the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
Regarding claim 9, the prior art combination teaches the liquid-tight case of claim 7.
The prior art combination is silent to the material of the seal.
However, Kamen discloses it is known in the art to use a gasket, i.e., a seal, made of an elastomeric material ([0312]) used to create a fluid tight seal between two components (last sentence of [0312]).
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 prior art combination seal such that it is made of an elastomeric material as it would predictably create a fluid tight seal between the base and the lid.
Regarding claim 10, the prior art combination teaches the liquid-tight case of claim 7.
Kamen discloses wherein the seal can be an O-ring ([0312]).
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 prior art combination seal such that it is an O-ring as it would predictably create a fluid tight seal between the base and the lid.
Regarding claim 12, the prior art combination teaches the liquid-tight case of claim 7.
Kamen of the prior art combination discloses wherein the first inlet port, the second inlet port, and at least one outlet port are coupled with the lid or the base, as set forth above.
Regarding claim 13, the prior art combination teaches the liquid-tight case of claim 12.
Kamen of the prior art combination discloses wherein the first inlet port, the second inlet port, or each of the first and second inlet ports comprises a barbed outer connector coupled with an exterior side of the lid or the base to connect a tube ([0155], “Fitting 1004 may be any of a variety of fittings such as a barb fitting”).
Regarding claim 14, the prior art combination teaches the liquid-tight case of claim 12.
Kamen of the prior art combination discloses wherein the at least one outlet port comprises a first outlet port, as set forth above.
Kamen further discloses wherein the base of the housing is formed with a sheath accommodating a tubing of the first outlet port (Fig. 3, adapter 23 allows tubing to pass through via pass-through 1002).
Although the prior art combination does not disclose or teach the sheath being formed monolithically, it has been held that the patentability of product-by-process claims is based on the product itself (MPEP § 2113 I).
Regarding claim 15, the prior art combination teaches the liquid-tight case of claim 12.
The prior art combination does not disclose or teach the claimed location of the first and second inlet ports or the at least one outlet port.
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 location of the prior art combination inlet ports and outlet ports as such a modification would amount to mere rearrangement of parts. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). In this case, arranging the first and second inlet ports and the at least one outlet port would predictably change the fluidic ingress and egress of the housing.
Regarding claim 16, the prior art combination teaches the liquid-tight case of claim 15.
Kamen of the prior art combination discloses wherein each of the first and second inlet ports comprises a barbed outer connector formed at an exterior side of the first portion of the base to connect a first tube, and wherein a barbed inner connector is formed at an interior side of the first portion of the base to connect a second tube and direct connection to the tissue device (Figs. 23 and 25B).
The limitations “to connect a first tube” and “to connect a second tube and direct connection to the tissue device” are directed toward the intended manner of operating the claimed barbed outer and barbed inner connectors, respectively, and do not differentiate the claimed structures from the corresponding prior art structures because all structural limitations are taught in the prior art (MPEP § 2114 II). Kamen’s barbed connectors would be fully capable of achieving every claimed intended use because the barbed connectors are disclosed to be used for connecting tubes (Fig. 23 and [0177]).
Regarding claim 17, the prior art combination teaches the liquid-tight case of claim 15.
The prior art combination does not disclose or teach wherein the first and second portions of the base are opposite to each other.
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 prior art combination first and second portions to be opposite each other as such a modification would amount to mere rearrangement of parts. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). In this case, such a modification would predictably change the fluidic ingress and egress of the housing.
Regarding claim 18, the prior art combination teaches the liquid-tight case of claim 12.
The prior art combination does not disclose or teach wherein the first and second inlet ports are coupled with the lid.
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 prior art combination first and second inlet ports to be coupled with the lid as such a modification would amount to mere rearrangement of parts. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). In this case, arranging the first and second inlet ports would predictably change the fluidic ingress of the housing.
Regarding claim 19, the prior art combination teaches the liquid-tight case of claim 18.
The prior art combination does not disclose or teach wherein each of the first and second inlet ports comprises a barbed outer connector coupled with an exterior side of the lid to connect a first tube, and wherein a barbed inner connector is coupled with an interior side of the lid to connect a second tube and direct connection to the tissue device.
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 location of the prior art barbed outer and inner connectors as such a modification would amount to mere rearrangement of parts. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). In this case, the barbed connectors would serve the same purpose of connecting tubes to the housing.
The limitations “to connect a first tube” and “to connect a second tube and direct connection to the tissue device” are directed toward the intended manner of operating the claimed barbed outer and barbed inner connectors, respectively, and do not differentiate the claimed structures from the corresponding prior art structures because all structural limitations are taught in the prior art (MPEP § 2114 II). Kamen’s barbed connectors would be fully capable of achieving every claimed intended use because the barbed connectors are disclosed to be used for connecting tubes (Fig. 23 and [0177]).
Regarding claim 22, the prior art combination teaches the liquid-tight case of claim 2.
The claim as written is directed to the manner of forming the housing. It has been held that the patentability of product-by-process claims is based on the product itself (MPEP § 2113 I). Note: Examiner is interpreting the phrase monolithic structure as “a structure formed from a single piece”.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of Vacanti-1 as applied to claim 10 above, and further in view of Toner et al. (US Patent 6,562,616 B1) (hereinafter referred to as Toner, already of record).
Regarding claim 11, the prior art combination teaches the liquid-tight case of claim 10.
The prior art combination does not disclose or teach wherein the base comprises a rim and a groove formed along the rim to accommodate the seal.
However, Toner in in the analogous art of tissue culturing teaches it is known in the art to form a base comprising a flange, i.e., a rim, and a groove formed along the flange to accommodate an O-ring, i.e., a seal (Col. 16, lines 17-20; Fig. 8B, groove 84 formed on flange 15 of housing 16).
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 prior art combination base to comprise a rim and a groove formed along the rim to accommodate the seal as such a feature is known in the art for the same purpose.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of Vacanti-1 OR Kamen in view of Vacanti-1 as applied to claim 2 above, and further in view of Vacanti et al. (US 2019/0358367 A1) (hereinafter referred to as Vacanti-2, presented in IDS filed 5/8/2026).
Regarding claim 21, the prior art combination teaches the liquid-tight case of claim 2.
Kamen of the prior art combination discloses an inner connector at an interior side of the housing (Fig. 3, connector 1004 has a portion on the interior side of the housing) for the purpose of connecting a tube ([0155]).
Examiner finds that Vacanti-1 meets the limitation of an input of the first channel network for the reason discussed above (see claim 4 rejection under 35 U.S.C. 103).
The prior art combination does not explicitly disclose or teach the connection between an inner connector to an input of the first channel network.
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 prior art combination such that the inner connector is connected directly to an input of the first channel network to provide fluid communication between the tissue device and the outside of the housing, and the ordinarily skilled artisan would be motivated to provide media to the tissue device without compromising sterility.
Assuming arguendo that Vacanti-1 fails to meet the limitation of note, Vacanti-2 in the analogous art of biomimetic structures discloses a channel network with an input (Fig. 1, inlet 100-1-I) as means to provide media to the channel network.
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 prior art combination first channel network to comprise an inlet and directly connect the input with the inner connector to provide media to the first channel network, and the ordinarily skilled artisan would be motivated to seed the tissue device with cells.
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
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