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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/06/2023 and 12/01/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-14 in the reply filed on 05/13/2026 is acknowledged.
Claims 15-16 and 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/13/2026.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Machluf et al. (hereinafter Machluf) WO 2016/048243 cited in the IDS filed 10/06/2023 in view of Bellan et al. (hereinafter Bellan) WO 2020/041376 cited in the IDS filed 10/06/2023.
Regarding claim 1, Machluf discloses a bioreactor module 200 for fabricating a perfusable three-dimensional tissue construct, the device comprising: a chamber (container 202) in which the tissue construct may be cultivated [0077-0078], the chamber comprising at least one inlet (inlet 206) and at least one outlet (outlet 212) for one or more fluid connections for perfusing the tissue construct [0074 and 0078]; and a sacrificial scaffold (scaffold 250) fixed in the chamber [0073 and 0077-0078]; wherein the sacrificial scaffold comprises at least one filament (inherent vascular network) extending from the at least one inlet to the at least one outlet [0069 and 0073-0074]. Machluf further discloses the sacrificial scaffold provides for a liquid channel from the inlet to the outlet [0066, 0069 and 0073-0074]. Also see whole document.
Machluf does not explicitly disclose that the sacrificial scaffold comprises a thermo-responsive polymer, the thermo-responsive polymer being not dissolvable in water at human body temperature and becoming dissolvable in water at a temperature below 30°C; such that dissolution of the sacrificial scaffold provides for a liquid channel from the inlet to the outlet; wherein the sacrificial scaffold seals either or both of the inlet and the outlet such that dissolution of the sacrificial scaffold after receiving a cultivation matrix in the chamber provides for a liquid channel from the inlet to the outlet through the cultivation matrix.
Bellan discloses a sacrificial scaffold comprises a thermo-responsive polymer, the thermo-responsive polymer being not dissolvable in water at human body temperature and becoming dissolvable in water at a temperature below 30°C [0020, 0022 and 0027].
Absent unexpected results, it would have been obvious to one of ordinary skill in the art to modify Machluf with a thermo-responsive polymer as taught by Bellan to create an artificial vasculature that allows, via perfusion, delivery of necessary soluble compounds to all cells throughout the scaffold volume in order maintain cell viability in thick engineered tissue. Without such a vasculature, cells will die from ischemia, leading to a necrotic core within the engineered tissue that limits the utility of the construct for regenerative or research applications [0004, Bellan].
The combination of Machluf and Bellan is capable of providing dissolution of the sacrificial scaffold to form a liquid channel from the inlet to the outlet; and forming seal at such that the sacrificial scaffold seals either or both of the inlet and the outlet such that dissolution of the sacrificial scaffold after receiving a cultivation matrix in the chamber provides for a liquid channel from the inlet to the outlet through the cultivation matrix.
Regarding the dissolution of the sacrificial scaffold and sealing at either or both of the inlet and the outlet, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP §§2114 and 2115. Further, it has been held that process limitations do not have patentable weight in an apparatus claim and “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” That is, an apparatus claims cover what a device is, not what a device does or how it is to be used.
Regarding claim 2, the rejection of claim 1 above is relied upon. The combination of Machluf and Bellan discloses wherein the sacrificial scaffold at least partially covers /or at least partially fills either or both of the inlet and the outlet.
Regarding claim 3, Machluf discloses wherein the sacrificial scaffold is fixated to either or both of the inlet and the outlet by a fixation feature (holder 204) that engages with a corresponding engagement feature provided in the chamber (Accordingly, the holder 204 may be inserted into the container 202 via the opening in the top surface of the container 202, and the holder 204 may be removed from the container 202 from the top surface of the container 202.) [0072-0073 and 0077].
Regarding claim 4, Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP § 2113. Therefore, the combination of Machluf and Bellan meets the claim.
Regarding claim 5, the combination of Machluf and Bellan does not expressly disclose wherein the thermo-responsive polymer is a poly(oxazoline). However, Bellan does disclose that the thermoresponsive polymer may include any thermoresponsive polymer that is biocompatible for culturing living cells [0028].
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to use a poly(oxazoline), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07.
Regarding claim 6, Machluf discloses wherein the sacrificial scaffold comprises a plurality of connected filaments forming a network (inherent vascular network) [0069 and 0073-0074].
Regarding claim 7, Machluf discloses wherein the sacrificial scaffold has at least one first node at which one filament branches into two or more filaments, and the sacrificial scaffold has at least one second node at which two or more filaments merge into one filament as shown in Fig. 2B reproduced below.
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Regarding claim 8, the combination of Machluf and Bellan does not expressly disclose wherein the sacrificial scaffold comprises a plurality of stacked two-dimensional components, each two-dimensional component comprising at least one filament.
Absent unexpected results, it would have been an obvious matter of design choice to provide a sacrificial scaffold with a plurality of stacked two-dimensional components, each two-dimensional component comprising at least one filament, since applicant has not disclosed that stacked two-dimensional components, each two-dimensional component comprising at least one filament solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the combination of Machluf and Bellan.
Regarding claim 9, Machluf discloses wherein the chamber comprises a top part with a further inlet (206) as shown in Fig. 2B.
As to filling a liquid precursor solution of the cultivation matrix into the chamber. the device disclosed by combination of Machluf and Bellan is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Machluf and Bellan is capable of providing the operating conditions as listed in the intended use section of the claim.
Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 10, the combination of Machluf and Bellan does not expressly disclose a first compartment in connection to the inlet via a first channel and a second compartment in connection to the outlet via a second channel, wherein the either or both of first compartment and the second compartment is a medium reservoir.
However, Machluf does disclose a first compartment container 204 in connection to the inlet via a first channel and a second compartment, medium reservoir 322 [0084].
Absent unexpected results, it would have been prima facie obvious to one of ordinary to modify the combination of Machluf and Bellan such that second compartment in connection to the outlet via a second channel, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP §2144.04 (VI-C).
Regarding claim 11, the combination of Machluf and Bellan does not expressly disclose an upper part defining the first compartment and the second compartment; a lower part comprising the sacrificial scaffold; and a separation structure separating the upper part and the lower part, wherein the inlet and the outlet of the chamber are fluidly connected to the first compartment and to the second compartment through the separation structure.
Absent unexpected results, it would have been an obvious matter of design choice to provide an upper part defining the first compartment and the second compartment; a lower part comprising the sacrificial scaffold; and a separation structure separating the upper part and the lower part, wherein the inlet and the outlet of the chamber are fluidly connected to the first compartment and to the second compartment through the separation structure, since applicant has not disclosed that an upper part defining the first compartment and the second compartment; a lower part comprising the sacrificial scaffold; and a separation structure separating the upper part and the lower part, wherein the inlet and the outlet of the chamber are fluidly connected to the first compartment and to the second compartment through the separation structure solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the combination of Machluf and Bellan.
Regarding claim 12, Machluf discloses wherein the device comprises a bottom part (container 202) and a top part (holder 204), wherein a volume of the chamber configured to receive the cultivation matrix therein extends into said bottom part and into said top part [0070-0075 and 0087]. Also see Figs. 2A, 2B and 3.
Regarding claim 13, the device disclosed by combination of Machluf and Bellan is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Machluf and Bellan is capable of providing the operating conditions (wherein the chamber is configured to receive the cultivation matrix, in which cells of the tissue construct may be cultivated, wherein dissolution of the sacrificial scaffold after receiving the cultivation matrix in the chamber provides for the liquid channel from the inlet to the outlet through the cultivation matrix with the cultivation matrix sealing around the inlet and the outlet) as listed in the intended use section of the claim.
Further, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP §§2114 and 2115. Further, it has been held that process limitations do not have patentable weight in an apparatus claim and “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” That is, an apparatus claims cover what a device is, not what a device does or how it is to be used.
Regarding claim 14, the device disclosed by combination of Machluf and Bellan is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Machluf and Bellan is capable of providing the operating conditions (producing a channel having a channel diameter of at least 5 µm; and wherein the sacrificial scaffold is configured to produce a channel having a channel diameter of 400 µm or less.) as listed in the intended use section of the claim.
Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
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