DETAILED ACTION
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 10-13 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.
Independent claim 10 requires “at least one second filtration zone” in line 10. However, the claim does not include a first filtration zone as a limitation, and therefore it is unclear how many filtration zones are required by the claim.
Independent claim 10 recites the limitation "the first filtered material" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Independent claim 10 requires “a second pore size” in line 12. However, the claim does not include a first pore size as a limitation, and therefore it is unclear how many different and distinct pore sizes are required by the claim.
Independent claim 10 requires “second filtered contents” in line 14. However, the claim does not include a first filtered contents as a limitation, and therefore it is unclear how many filtration steps and filtered content products are required by the claim.
The amendment to the claims filed on 28 May 2026 does not comply with the requirements of 37 CFR 1.121(c) because the third paragraph following the preamble appears to be have been deleted without any marked-up indication using a strikethrough or brackets.
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, 2, 4, 5, 8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujiyama (US 20160281064).
With respect to claims 1 and 10, Fujiyama discloses a tissue enclosure enabling creation, maintenance and monitoring of tissue comprising an incoming chamber (Figure 1:17) for admitting a first material in response to a differential pressure, a core including a cavity (Figure 1:15) and a filtration zone (Figure 1:11). The core includes a material ingress (Figure 1:9b), a material egress (Figure 1:13a), and a gel layer (Figure 1:25) to maintain a position of tissue in the cavity. The filter 11 of the filtration zone is positioned between the tissue in the gel layer and the material egress. An effluent chamber (Figure 1:19) receives filtered contents from the core cavity and includes a vacuum outlet. Fig.4 shows an example in which a vacuum negative pressure force is applied to the effluent chamber using a pump (Figure 4:41). This is described in paragraphs [0041]-[0055]. Tissue within the cavity may be monitored using at least one monitoring area, especially given that claims 1 and 10 do not contain any requirements for what constitutes a monitoring area.
With respect to claim 2, Fujiyama discloses the apparatus as described above. Fujiyama shows that a plenum (Figure 1:23) is formed on an opposite side of the filter (Figure 1:11) with respect to the cavity.
With respect to claims 4 and 5, Fujiyama discloses the apparatus as described above. Fujiyama indicates that a fluid medium surrounds the tissue disposed in the cavity, and that the tissue cells are disposed on a gel 25.
With respect to claim 8, Fujiyama discloses the apparatus as described above. Fujiyama shows that a tissue enclosure top (Figure 1:13) is removably connected to the core.
Claims 14 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wolfinbarger (US 6416995).
With respect to claim 14, Wolfinbarger discloses a system for incubating an organ comprising an organ scaffold (Figure 1:1) hosting the organ. A tube (Figure 1:9) is coupled with the organ scaffold in order to provide a conduit between a fluid source and the organ scaffold. A chamber (Figure 13:16) houses the organ scaffold and includes at least one inlet and at least one outlet for receiving fluids, maintaining the viability of the organ and evacuating wastes. This is shown in Fig. 16 and described in at least column 10, lines 36-63. Column 11, lines 4-14 state that a flow (Figure 1:13) through an internal fluid cavity of the organ scaffold produces a pressure that causes the scaffold to expand (i.e., inflate) and then deflate according to a fill/empty cycle. Furthermore, it is well established that apparatus claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed (here, the application of pressure according to a fill/empty cycle) does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim
With respect to claim 15, Wolfinbarger discloses the system as described above. Wolfinbarger shows that at least one pump (Figure 13:17, 17a, 18) is used to apply a pressure to pump fluids and wastes through the chamber.
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, 4, 5, 8-10, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Llabjani (US 20180371390) in view of Smith (US 20140186937).
With respect to claim 1, Llabjani discloses a tissue enclosure enabling creation, maintenance and monitoring of tissue comprising a core (Figure 2:2) including a cavity. The cavity comprises at least one monitoring area where tissue scaffold blocks (Figure 2:3) are positioned, and paragraphs [0018]-[0036] indicate that the tissue is surrounded by a medium that may include a gel. Paragraphs [0112]-[0117] teach that a plurality of filter assemblies (Figure 2:4) is coupled with the core and may be positioned to surround the tissue scaffold blocks. The pores of the filters are selected to confine the tissue within the cavity. Paragraphs [0088]-[0091] further state that a transparent window is provided along a wall of the core to facilitate optical monitoring of the tissue. Llabjani, however, does not state that the core includes at least one opening that enables the tissue to be maintained by flowing a fluid through a material ingress and egress using a pressure differential created through the application of a vacuum.
Smith discloses a tissue enclosure enabling creation, maintenance and monitoring of tissue comprising a core (Figure 5:118) that includes at least one cavity (Figure 11:202). Tissue cells are grown in the cavity, and at least one opening is provided for flowing fluid through a material ingress and egress. The material egress is connected to a waste chamber that functions as an effluent chamber. This is described in paragraphs [0181]-[0183]. Paragraphs [0189] and [0190] teach that filters (Figure 12:316a,b,c) are provided at opposite ends of the cavity and function to retain tissue within the cavity.
Before the effective filing date of the claimed invention, it would have been obvious to provide the Llabjani core with at least one opening to allow for the perfusion of a fluid. Smith teaches that tissue cells require a supply of nutrients, and that filters may be provided to allow for the diffusion of liquids containing nutrients and growth factors into a cell growth location and the passage of waste products out of a cell growth location while retaining the cells. Smith specifically teaches that filter pore diameter can be chosen to admit/exclude compounds of a particular size in an effort to optimize tissue growth.
With respect to claims 4 and 5, Llabjani and Smith disclose the combination as described above. Llabjani further states in paragraphs [0018]-[0036] that the tissue is surrounded by a medium that may include a gel.
With respect to claim 8, Llabjani and Smith disclose the combination as described above. Llabjani shows that the core is mated with a tissue enclosure top (Figure 2:5) that is removable.
With respect to claim 9, Llabjani and Smith disclose the combination as described above. As previously discussed, Llabjani teaches in paragraphs [0088]-[0091] that a transparent window is provided along a wall of the core to facilitate optical monitoring of the tissue.
With respect to claims 10 and 12, Llabjani and Smith disclose the combination as described above. Paragraphs [0058]-[0077] of Llabjani state that a first compartment may be filled with a fluid containing a first material in order to pass the first material through a first filtration zone and into contact with the tissue (“For example one compartment may contain cell growth blocks and another compartment may contain media incorporating a test substance (for instance, drugs, chemical pollutants, viruses, bacteria) and the diffusion of the test substance can then be controlled to replicate living conditions. A divider will serve as a diffusive layer to control the movement or selection of material allowed to cross the barrier. For example, cancerous cell culture can be exposed to the testing substance at a diffusion rate that is controlled to replicate the environment of living tissue”). This first compartment functions as an incoming chamber. Llabjani further states that a second filtration zone (the Llabjani system utilizes a plurality of dividers) may be provided on an opposite side of the tissue to control the diffusion metabolic products and wastes. Accordingly, fluid passing through the second filtration zone collects in an effluent chamber.
With respect to claim 13, Llabjani and Smith disclose the combination as described above. Llabjani and Smith each teach various connection means that read on the claimed “mount button”.
Claims 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Llabjani (US 20180371390) in view of Smith (US 20140186937) as applied to claim 1, and further in view of Kane (US 20040149659).
Llabjani and Smith disclose the combination as described above, however do not expressly state that the filter assembly includes at least one plenum.
Kane discloses a filter assembly for processing a biological fluid. The filter assembly includes a filter (Figure 5a:20) coupled to at least one filter support (Figure 5a:6) and filter frame (Figure 5a:40). A plenum is formed underneath the filter using a plurality of grid spacers (Figure 5a:81a-d, 83a-d, 84a-d). This is described in at least paragraphs [0060]-[0066].
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Llabjani filter assembly includes a filter, filter support, filter frame and plenum. Kane teaches that these features provide increased structural strength to the filter membrane, while also creating drainage channels that allow perfusate to effectively pass through the filter for collection. It is prima facie obvious to apply a known technique to a known device ready for improvement to yield predictable results. See MPEP 2143.
Claims 3, 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Llabjani (US 20180371390) in view of Smith (US 20140186937) as applied to claims 1 and 10, and further in view of O’Mahony (US 20180230423).
Llabjani and Smith disclose the combination as described above, however do not state that the core includes a heater and is compatible with 3D printing.
O’Mahony discloses a tissue enclosure for growing tissue cells in a hydrogel matrix. See Fig. 3. O’Mahony teaches in paragraphs [0008]-[0032] that tissues are printed into the enclosure using a 3D printer. O’Mahony further states that a heater (see Fig. 1) is used to maintain the temperature of the cell culture.
Before the effective filing date of the claimed invention, it would have been obvious to provide the Llabjani device with a heater operable in combination with a multi-dimensional printer. As evidenced by O’Mahony, it is well known in the art that tissue cells are temperature-sensitive and require stabile environmental conditions. O’Mahony additionally teaches in paragraphs [0003]-[0007] that 3D printing techniques improve on two-dimensional techniques that are difficult, expensive and laborious. Furthermore, it is noted that the claim is drawn to a “tissue enclosure” that is not further limited by the recitation of a “multi-dimensional printer”, which is an external, independent structure. Apparatus claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed (here, 3D printing) 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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wolfinbarger (US 6416995) as applied to claim 14, and further in view of Fuhr (US 20060194309) and Breuer (US 20110281358).
Wolfinbarger discloses the system as described above and indicates that the organ scaffold comprises a fluid cavity for receiving and emitting fluids (Figure 1:13) into an interior of the organ scaffold. Wolfinbarger further states in column 14, line 42 to column 16, line 67 that a plurality of cells is disposed on the scaffold in a manner that is associated with the biology of the organ. Wolfinbarger, however, does not expressly state that the scaffold includes a compliant wrapper and at least one layer of fiber.
Fuhr discloses an organ scaffold comprising a fluid cavity (Figure 1B:31) coupled to a tube (Figure 1A:13). The fluid cavity is configured to receive and emit fluids into and out of the organ scaffold. A compliant wrapper (Figure 1A:12) enables inflation and deflation of the cavity. This is taught in at least paragraphs [0038]-[0044]. Fuhr further states that a plurality of cells (Figure 1C:20, 22) are disposed on an outer layer of the scaffold to mimic the biology of an organ.
Breuer discloses an organ scaffold (Figure 1A:21) having a fluid cavity for receiving and emitting a fluid. At least paragraphs [0079]-[0086] teach that the scaffold is configured as a three-dimensional matrix formed of polymeric fibers that are assembled as a mesh.
Before the effective filing date of the claimed invention, it would have been obvious to provide the Wolfinbarger scaffold with a compliant wrapper and at least one layer of fibrous material. Fuhr teaches that compliant and elastic materials, such as silicone membranes, are useful because they permit stretching and strain forces that mimic in vivo conditions. Breuer teaches that fiber layers are typically incorporated into organ scaffolds because include pores sized to allow cells to adhere, grow and/or differentiate, while also facilitating the diffusion of critical gases, wastes and nutrients.
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 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,939,566.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of U.S. Pat. No. 11,939,566 include limitations directed to:
A tissue enclosure enabling creation, maintenance, and monitoring of tissue comprising:
a core including a cavity, the core having at least one monitoring area and at least one opening into the cavity, one of the at least one openings receiving the tissue, the core accommodating at least one material ingress and at least one material egress; and
at least one filter assembly operably coupled with the core, wherein the tissue is confined within the cavity by the at least one filter assembly, and wherein the life of the tissue is maintained at least by fluid flowing through the cavity between the at least one material ingress and the at least one material egress, and
wherein the tissue is monitored through the at least one monitoring area.
The claims of U.S. Pat. No. 11,939,566 further include limitations directed to:
A tissue enclosure enabling creation, maintenance, and monitoring of tissue comprising:
an incoming chamber admitting a first material, the incoming chamber emitting the first material in response to a differential pressure within the tissue enclosure;
a core including a cavity, the core having at least one monitoring area and at least one opening into the cavity, the core accommodating at least one material ingress and at least one material egress, the core containing the tissue, media, and metabolism products from the tissue;
at least one first filtration zone operably positioned between the incoming chamber and the core, the filtration zone subjecting the first material to at least one filter having a first pore size based at least on the first material, the filtration zone emitting first filtered contents to the core based at least on the first material and the first pore size;
at least one second filtration zone operably coupled with the core, the at least one second filtration zone subjecting the first filtered material, the media, the tissue, and the metabolism products to at least one filter having a second pore size based at least on the first filtered material, the media, the tissue, and the metabolism products, the filtration zone emitting second filtered contents based at least on the first filtered material, the media, the tissue, the metabolism products, and the second pore size; and
an effluent chamber admitting the second filtered contents, the effluent chamber managing the filtered contents,
wherein the tissue enters the cavity through the at least one opening,
wherein the tissue is confined within the cavity by the at least one first filtration zone and the at least one second filtration zone,
wherein the life of the tissue is maintained by the first material entering the cavity through the at least one material ingress and by the metabolism products exiting the cavity through the at least one material egress, and
wherein the tissue is monitored through the at least one monitoring area.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,618,042.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of U.S. Pat. No. 12,618,042 include limitations directed to:
A tissue enclosure enabling creation, maintenance, and monitoring of tissue comprising:
a core including a cavity, the core having at least one monitoring area and at least one opening into the cavity, one of the at least one openings receiving the tissue, the core accommodating at least one material ingress and at least one material egress;
and at least one filter assembly operably coupled with the core, wherein the tissue is confined within the cavity by the at least one filter assembly, and wherein the life of the tissue is maintained at least by fluid flowing through the cavity between the at least one material ingress and the at least one material egress, and
wherein the tissue is monitored through the at least one monitoring area.
The claims of U.S. Pat. No. 12,618,042 further include limitations directed to:
A tissue enclosure enabling creation, maintenance, and monitoring of tissue comprising:
an incoming chamber admitting a first material, the incoming chamber emitting the first material in response to a differential pressure within the tissue enclosure;
a core including a cavity, the core having at least one monitoring area and at least one opening into the cavity, the core accommodating at least one material ingress and at least one material egress, the core containing the tissue, media, and metabolism products from the tissue;
at least one first filtration zone operably positioned between the incoming chamber and the core, the filtration zone subjecting the first material to at least one filter having a first pore size based at least on the first material, the filtration zone emitting first filtered contents to the core based at least on the first material and the first pore size;
at least one second filtration zone operably coupled with the core, the at least one second filtration zone subjecting the first filtered material, the media, the tissue, and the metabolism products to at least one filter having a second pore size based at least on the first filtered material, the media, the tissue, and the metabolism products, the filtration zone emitting second filtered contents based at least on the first filtered material, the media, the tissue, the metabolism products, and the second pore size; and
an effluent chamber admitting the second filtered contents, the effluent chamber managing the filtered contents,
wherein the tissue enters the cavity through the at least one opening,
wherein the tissue is confined within the cavity by the at least one first filtration zone and the at least one second filtration zone,
wherein the life of the tissue is maintained by the first material entering the cavity through the at least one material ingress and by the metabolism products exiting the cavity through the at least one material egress, and
wherein the tissue is monitored through the at least one monitoring area.
Response to Arguments
In response to Applicant’s amendment filed 28 May 2026, new grounds of rejection are made over 35 U.S.C. 112, 102 and 103.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
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