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 1-22 and 30 in the reply filed on 15 October 2025 is acknowledged.
Claims 23-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 15 October 2025.
Claim Objections
Claims 19, 21 and 30 are objected to because of the following informalities:
Claim 19 should be amended to recite “The modular system of claim 18…”
Claim 21 should be amended to recite “cells” instead of “calls”.
Claim 30 includes a ( symbol in line 8 that should be deleted.
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.
Claims 7 and 19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 7 recites the limitation "the interfacial member" in lines 1-2. It is unclear if this is intended to refer back to the platform interfacial member or the tissue chamber interfacial member previously recited in independent claim 1.
Claim 19 recites the limitations "the first releasable module tissue chamber", "the second releasable module tissue chamber", "the third releasable module tissue chamber", and "the fourth releasable module tissue chamber" in lines 1-4. There is insufficient antecedent basis for these limitations in the claim.
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 person shall be entitled to a patent unless –
(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, 8, 10-12, 15 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cuiffi (US 20170137768).
With respect to claim 1, Cuiffi discloses a modular bioreactor system comprising a platform (Figure 2:204) having a bottom surface, a top surface, and a seat to receive a releasable modular tissue chamber (Figure 2:206). The releasable modular tissue chamber includes a bottom surface, an open top and sidewalls to define a wall therein. This is described in paragraphs [0092]-[0095] and shown in Fig. 6. The releasable modular tissue chamber is configured to be received by the seat of the platform.
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Paragraphs [0078]-[0082] teach that interfacial members of the platform communicate with corresponding interfacial members of the releasable module tissue chamber in order to properly orient and connect the tissue chamber to the platform (“The top surface of the fluid flow plate 500 includes a plurality recesses (or mortises) 504. As described below, the cell culture vessels 206 include matching projections (or tenons). The mortises 504 and tenons interlock and properly align cell culture vessels 206 with the flow ports 502” and “each cell culture vessel 206 can include the above described tenons and fluid ports at predetermined locations so the cell culture vessels 206 can be placed in any cell culture vessel slot on the fluid flow plate”).
With respect to claim 2, Cuiffi discloses the apparatus as described above. Cuiffi further states that the platform includes media entrance and exit ports (Figure 5A:502) disposed on a top surface of the platform that enable fluid to be added to and removed from the tissue chamber.
With respect to claims 3, 4 and 15, Cuiffi discloses the apparatus as described above. Cuiffi shows that the platform includes a media reservoir and channel (Figure 5B:508) disposed on a bottom surface.
With respect to claims 8 and 10, Cuiffi discloses the apparatus as described above. Cuiffi further teaches that a plate (Figure 2:202) is disposed beneath the platform, and that the plate includes a pump. See paragraph [0055].
With respect to claims 11 and 12, Cuiffi discloses the apparatus as described above. Cuiffi further shows in Fig. 2 that the platform is configured to receive a plurality of modular tissue chambers 206, wherein the modular tissue chambers are releasably insertable into the platform and arranged in a side-by-side configuration when seated on the platform. See paragraphs [0046]-[0052].
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With respect to claim 16, Cuiffi discloses the apparatus as described above. Cuiffi additionally teaches that the tissue chambers include a selectively permeable barrier (Figure 6:608) disposed at the bottom surface to permit the selective perfusion of media flowing through the system.
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.
Claims 5-7, 13, 14, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cuiffi (US 20170137768) as applied to claims 1 and 12, and further in view of Ariff (US 20080014181), Quenin (US 4931257) and/or Saxholm (US 4324859).
With respect to claims 5-7, 13 and 14, Cuiffi discloses the apparatus as described above. Although Cuiffi teaches interfacial members configured as interlocking tenons and mortises, Cuiffi does not appear to teach interfacial members configured as arms, pivotable levers and ledges.
Ariff discloses a modular cell processing system comprising a releasable modular tissue chamber that is connected to a platform. The platform includes an interfacial member configured as an arm that interlocks with an interfacial member of the tissue chamber configured as a ledge. See Figs. 2D-2F and paragraph [0031].
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Quenin discloses a variety of different interfacial members designed to produce a releasable connection between biological processing units. Quenin shows how a pivotable lever (Figure 4:44) is provided to effectuate a removable connection when a chamber (Figure 1:10) is inserted into the seat of a platform (Figure 3:20). The platform may further include a second interfacial member configured as an arm (Figure 6:60) that interacts with a second interfacial member of the chamber configured as a ledge (Figure 6:62). Alternative designs for the pivotable lever (Figure 8:90,91) are disclosed, such that the pivotable lever interacts with an interfacial member configured as a slots/stops (Figure 10:22).
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Saxholm discloses a modular bioreactor system in which a releasable modular culture chamber is mated to a platform. Saxholm shows a variety of different interfacial member designs to achieve the connection, including arms, levers and ledges. See Figs. 24-31. Saxholm further shows how a pivotable lever (Figure 37:922) of the chamber is configured to interlock with a projecting arm (Figure 37:923) of the platform.
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Before the effective filing date of the claimed invention, it would have been obvious to provide the interfacial members of Cuiffi in a variety of different designs shown to be effective for producing a releasable sealing connection. Ariff, Quenin and Saxholm are evidence that it would have been within the ability of one of ordinary skill to choose from the many arm, lever, ledge, etc. interfacial members known in the art as suitable for creating a reversable sealing effect. Indeed, the terms “arm”, “lever” and “ledge” are broad recitations that read on a variety of different interlocking designs that are notoriously well known (e.g., screws, clips, snaps, slots, springs).
With respect to claims 17 and 18, Cuiffi and Ariff/Quenin/Saxholm disclose the combination as described above. Cuiffi further teaches in paragraphs [0015] and [0107] that more than four releasable modular tissue chambers are provided (see Fig. 2) and that each tissue chamber includes a different tissue type.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Cuiffi (US 20170137768) as applied to claim 1, and further in view of Collins (US 20190358633).
Cuiffi discloses the apparatus as described above, however does not appear to teach that a pump is supported on the platform using a back stand.
Collins discloses a modular bioreactor system comprising a cell culture chamber (Figure 1A:101) supported on a platform comprising a back stand having a pump (Figure 1B:106). This is described in paragraph [0159].
Before the effective filing date of the claimed invention, it would have been obvious to provide the Cuiffi system with a back stand for supporting peripheral devices, such as a pump. Collins shows how a back stand may be used to position a pump and other elements necessary for cell culture (e.g., fluid supply, waste bottle, power supply) in an organized manner adjacent to the culture chamber module.
Claims 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Cuiffi (US 20170137768) in view of Ariff (US 20080014181), Quenin (US 4931257) and/or Saxholm (US 4324859) as applied to claims 13 and 18, and further in view of Wikswo (US 9725687) and Parietti (US 20210324318).
Cuiffi and Ariff/Quenin/Saxholm disclose the combination as described above. Although Cuiffi teaches a plurality of modular tissue chambers that each include a different tissue type, Cuiffi does not expressly teach the tissue groups required by the claims.
Wikswo discloses a modular bioreactor system comprising a platform having a bottom surface, a top surface, and a seat to receive a modular tissue chamber. A plurality of releasable modular tissue chambers are disposed on the platform and are configured to include liver tissue, heart tissue, skin tissue, lung tissue and bone tissue. See Fig. 2 and column 7, line 54 to column 9, line 27 and column 12, line 54 to column 18, line 29. Media containing tumor cells and/or immune cells is circulated through the tissue chambers.
Parietti discloses a modular bioreactor system comprising a plurality of releasable modular tissue chambers (Figure 3:300). The chambers are configured to culture, engineer and analyze a variety of different cell types from a patient, including osteosarcoma cells and breast adenocarcinoma cells. Media containing tumor cells and/or immune cells is circulated through the tissue chambers. This is taught in paragraphs [0180] and [0185]-[0189].
Before the effective filing date of the claimed invention, it would have been obvious to use the Cuiffi apparatus to model a wide variety of tissue systems and to analyze cell samples obtained from a patient. Wikswo indicates that there is a need to produce integrated microphysiological systems that can shorten the drug development timeline, save animal lives, reduce failure rates, inform regulatory decision-making, and accelerate development of new therapeutics in the face of emerging infectious diseases, as well as chemical or biological attack. Parietti teaches that it is often necessary to treat patients using cell therapies in which the cells of a subject are extracted, manipulated, and returned to the patient in order to achieve a therapeutic effect.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Cuiffi (US 20170137768) in view of Mokhtari (US 20220238042).
Cuiffi discloses a modular bioreactor system comprising a platform (Figure 2:204) having a bottom surface, a top surface, and a seat to receive a releasable modular tissue chamber (Figure 2:206). The releasable modular tissue chamber includes a bottom surface, an open top and sidewalls to define a wall therein. This is described in paragraphs [0092]-[0095] and shown in Fig. 6. The releasable modular tissue chamber is configured to be received by the seat of the platform. Paragraphs [0078]-[0082] teach that interfacial members of the platform communicate with corresponding interfacial members of the releasable module tissue chamber in order to properly orient and connect the tissue chamber to the platform (“The top surface of the fluid flow plate 500 includes a plurality recesses (or mortises) 504. As described below, the cell culture vessels 206 include matching projections (or tenons). The mortises 504 and tenons interlock and properly align cell culture vessels 206 with the flow ports 502” and “each cell culture vessel 206 can include the above described tenons and fluid ports at predetermined locations so the cell culture vessels 206 can be placed in any cell culture vessel slot on the fluid flow plate”). Cuiffi, however, does not expressly teach that the tissue chamber contains human bone marrow.
Mokhtari discloses a modular bioreactor system comprising a plurality of releasable modular tissue chambers (see Fig. 39). The chambers are configured to culture, engineer and analyze a variety of different cell types from a patient, including human bone marrow engineered using iPS cells derived from osteoblasts, osteoclasts, endothelial cells, supporting mesenchymal cells and hematopoietic cells in bone matrix infused by primary leukemia cells. This is taught in paragraphs [0121], [0298]-[0306] and [0392].
Before the effective filing date of the claimed invention, it would have been obvious to use the Cuiffi system so that at least one modular tissue chamber is configured as a bone marrow model. Mokhtari teaches that such models may provide personalized medical analysis and are useful for studying the maintenance, differentiation and regulation of stem cells in the bone marrow in response to complex structural, physical, molecular and cellular cues. Mokhtari states that different models of implementation of bone marrow can be used to investigate a myriad of subjects, including but not limited to: disease progression (such as in early detection of cancer), therapeutics, drug screening, toxicology, radiation/radiotherapy and drug side effects, safety and risk assessment, efficacy, engraftment, migration, metastasis, organ function assessment, drug and biomarker discovery, combination therapy, drug-drug interaction, and bone autograft and allograft techniques.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-22 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-56 of copending Application No. 17/992,779 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other. Independent claim 30 of copending Application No. 17/992,779 includes limitations drawn to:
A modular bioreactor system comprising: a platform having a bottom surface, a surface, a seat to receive a modular tissue chamber, and one or more platform interfacial members; and a releasable modular tissue chamber including a bottom surface, an open top, and sidewalls defining a well therein, the releasable modular tissue chamber configured to be received by the seat of the platform, the tissue chamber further including an interfacial member configured to releasably connect the modular tissue chamber to the platform.
More specifically, independent claim 30 of copending Application No. 17/992,779 includes limitations drawn to first and second coupling members, which correspond to the claimed interfacial members set forth in the instant application. The claims of both applications discuss modular bioreactor systems comprising a plurality of releasable modular tissue chambers disposed on a platform. Claims 40-46 and 54-56 of copending Application No. 17/992,779 include limitations drawn to a variety of tissue and cell types (liver, heart, skin, lung, bone marrow, osteosarcoma cells, breast adenocarcinoma cells, etc.).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Gevaert (US 20170205397) reference teaches the state of the art regarding modular bioreactor systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799