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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/17/2026 has been entered.
Status of the Claims
The amendment filed 3/17/2026 has been entered. Claims 1-6, 8-9, 11, 13-15, 17, 19-24, and 26 are pending in the application; claims 19-24 remain withdrawn; and claims 7, 10, 12, 16, 18, and 25 are cancelled.
Response to Arguments
Applicant’s arguments filed 3/17/2026 have been considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
As discussed in the interview dated 2/19/2026, the amendments to claim 1 distinguish the claimed invention over the 103 rejection over Bach. However, it would have been obvious to modify the device of Bach in view of Campbell et al. (US 2018/0216057 A1) (already of record), as will be discussed in further detail in the 35 USC § 103 section below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 6, 8-9, 14-15, 17, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Bach (US 4,647,539) (already of record) in view of Campbell et al. (US 2018/0216057 A1) (already of record).
Regarding claim 1, Bach teaches a bioreactor chamber (Fig. 1 10 cell culture apparatus), comprising: a first end block (Fig. 5 end segment 14 on the left), wherein the first end block comprises a first-end-block outer member (Fig. 5 bulb-shaped end portion 30 on the left) and a first-end-block inner member (Fig. 5 potting compound 40 on the left); a second end block (Fig. 5 end segment on the right 14), wherein the second end block comprises a second-end-block outer member (Fig. 5 bulb-shaped end portion 30 on the right) and a second-end-block inner member (Fig. 5 potting compound 40 on the right); and a flexible membrane, extending between the first end block and the second end block, to define a cavity bounded by at least the flexible membrane (Fig. 5 middle segment 12; Col. 4, line 56 “middle segment 12 includes a flexible tubular wall”); and wherein the cavity is arranged to receive: a substrate, for growing a culture on the substrate (Fig. 5 capillaries 34); or a biomaterial for testing the biomaterial (Col. 2, line 18 “cells are implanted in the extracapillary space”).
Bach does not teach wherein the first end block and/or the second end block comprises an outer member and an inner member, and wherein the first-end-block outer member is attached to the first- end-block inner member such that a first section of the flexible membrane is clamped between the first-end-block outer member and the first-end-block inner member, so as to hold the flexible membrane in position between the first-end-block outer member and the first-end-block inner member by pressure so that the flexible membrane is clamped in the first end block; and wherein the second-end-block outer member is attached to the second-end-block inner member such that a second section of the flexible membrane is clamped between the second-end-block outer member and the second-end-block inner member, so as to hold the flexible membrane in position between the second-end-block outer member and the second-end-block inner member by pressure so that the flexible membrane is clamped in the second end block.
However, Campbell et al. teaches end block outer members (30 clips) and end block inner members (tabs 40), wherein a section of flexible membrane (tissue scaffold 100) is clamped between the end block outer members and the end block inner members, so as to hold the flexible membrane in position between the end block outer members and the end block inner members (Figs. 1A-1B, 2B-2D). Campbell et al. teaches that this configuration suspends and secures a tissue scaffold for culturing and mechanical testing (para. 0047). It would have been obvious to a person of ordinary skill in the art to use the Campbell et al. configuration of a membrane is clamped between an end block outer member and an end block inner member in Bach’s device with a reasonable expectation that it would suspend and secure a scaffold for culturing and mechanical testing. This method for improving Bach’s device was within the ability of one of ordinary skill in the art based on the teachings of Campbell et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bach and Campbell et al. to obtain the invention as specified in claim 1.
Regarding claim 2, Bach teaches a bioreactor chamber wherein the cavity is bounded by the first end block, the second end block and the flexible membrane (Fig. 5 culture space in middle segment 12 bounded by end segments 14 on the left and right).
Regarding claim 3, Bach teaches a bioreactor chamber wherein the cavity has a substantially tubular shape (Fig. 1 middle segment 12; Col. 4, line 56 “middle segment 12 includes a flexible tubular wall”).
Regarding claim 4, Bach teaches a bioreactor chamber wherein the flexible membrane is at least partly transparent (Col. 5, lines 3-4 “middle segment 12 is constructed of a transparent or translucent material”).
Regarding claim 6, Bach teaches a bioreactor chamber wherein the flexible membrane is sealingly connected to the first end block and/or the second end block (Fig. 5 middle segment 12 connected to end segments 14 by first ends 28; Col. 3, lines 23-26 “end segments 14 have a substantially tubular first end 28 of circular lateral cross section, which first ends 28 are secured to the inner edges 24 of the annular flanges 22 forming a fluid seal”).
Regarding claim 8, Bach teaches a bioreactor chamber comprising a first end block (Fig. 5 end segment 14 on the left) and a second end block (Fig. 5 end segment 14 on the right), but does not teach wherein the second end block comprises a ring and wherein the second-end-block inner member comprises an aperture: wherein the flexible membrane extends through the aperture in the second-end-block inner member, through the ring, and is folded back on itself to surround the ring, and wherein the flexible membrane further extends back through the aperture in the second-end-block inner member, and wherein the flexible membrane, the second-end-block outer member and the second-end-block inner member are attached together, and the ring is clamped between the second-end-block outer member and the second-end-block inner member.
However, Campbell et al. teaches wherein an end block comprises a ring (central slit 32) and a tab (40): wherein the flexible membrane extends through the ring and is folded back on itself to surround the tab and wherein the membrane extends back through the ring (Figs. 2B-2C). Campbell et al. teaches that this configuration suspends and secures a tissue scaffold for culturing and mechanical testing (para. 0047). It would have been obvious to a person of ordinary skill in the art to use the Campbell et al. configuration of ring and a tab which clamp a flexible membrane in Bach’s device with a reasonable expectation that it would suspend and secure a scaffold for culturing and mechanical testing. This method for improving Bach’s device was within the ability of one of ordinary skill in the art based on the teachings of Campbell et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bach and Campbell et al. to obtain the invention as specified in claim 8.
Regarding claim 9, Bach teaches a bioreactor chamber comprising a first end block (Fig. 5 end segment 14 on the left) and a second end block (Fig. 5 end segment 14 on the right), but does not teach wherein the second-end-block inner member comprises a recessed portion, wherein the recessed portion further comprises the aperture, and wherein the recessed portion at least partially contains the ring. However, Campbell et al. teaches an end block comprising a recessed portion/aperture (central slit 32), which suspends and secures a tissue scaffold for culturing and mechanical testing (para. 0047). It would have been obvious to a person of ordinary skill in the art to use the Campbell et al. configuration of a recessed portion/aperture in Bach’s device with a reasonable expectation that it would suspend and secure a scaffold for culturing and mechanical testing. This method for improving Bach’s device was within the ability of one of ordinary skill in the art based on the teachings of Campbell et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bach and Campbell et al. to obtain the invention as specified in claim 9.
Regarding claim 14, Bach teaches a bioreactor chamber comprising a first end block and a second end block (Fig. 5 end segments 14), but does not teach wherein the first end block and/or the second end block comprise a fixing point, for connection to a mechanical actuator. However, Campbell et al. teaches a fixing point for connection to a mechanical actuator (Fig. 7A arm 204 connected to actuator 202; para. 0064 “connection between the arms and clips can be achieved using any suitable means, such as using clamps, tabs, hooks, slots”). Campbell et al. teaches that the actuator mechanically stimulates tissue constructs to detect and assess the presence and degree of organ pathologies (abstract). It would have been obvious to a person of ordinary skill in the art to use the Campbell et al. configuration of a fixing point for connection to a mechanical actuator in Bach’s device with a reasonable expectation that the actuator would mechanically stimulate tissue constructs to detect and assess the presence and degree of organ pathologies. This method for improving Bach’s device was within the ability of one of ordinary skill in the art based on the teachings of Campbell et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bach and Campbell et al. to obtain the invention as specified in claim 14.
Regarding claim 15, Bach teaches a bioreactor chamber wherein the cavity comprises an inlet for cell culture medium (Fig. 5 port 50; Col. 3, line 68-Col. 4, line 2 “ports 50 fluidly communicate with the end chambers 44 and the lumens of the capillaries 34, for circulating a first fluid medium therethrough”).
Regarding claim 17, Bach teaches a bioreactor chamber wherein the first end block comprises the inlet (Fig. 5 port 50 on end segment 14 on the left) and the second end block comprises an outlet (Fig. 5 port 50 on end segment 14 on the right), and wherein the inlet and the outlet are arranged to be positioned offset from each other on opposing sides of the cavity (Fig. 5 ports 50 on opposite sides of the cavity).
Regarding claim 26, Bach teaches a bioreactor chamber comprising a first end block (Fig. 5 end segment 14 on the left) and a second end block (Fig. 5 end segment 14 on the right), but does not teach wherein the first end block comprises a ring and wherein the first-end-block inner member comprises an aperture: wherein the flexible membrane extends through the aperture in the first-end-block inner member, through the ring, and is folded back on itself to surround the ring, and wherein the flexible membrane further extends back through the aperture in the first-end-block inner member, and wherein the flexible membrane, the first-end-block outer member and the first-end-block inner member are attached together, and the ring is clamped between the first-end-block outer member and the first-end-block inner member.
However, Campbell et al. teaches wherein an end block comprises a ring (central slit 32) and a tab (40): wherein the flexible membrane extends through the ring and is folded back on itself to surround the tab and wherein the membrane extends back through the ring (Figs. 2B-2C). Campbell et al. teaches that this configuration suspends and secures a tissue scaffold for culturing and mechanical testing (para. 0047). It would have been obvious to a person of ordinary skill in the art to use the Campbell et al. configuration of ring and a tab which clamp a flexible membrane in Bach’s device with a reasonable expectation that it would suspend and secure a scaffold for culturing and mechanical testing. This method for improving Bach’s device was within the ability of one of ordinary skill in the art based on the teachings of Campbell et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bach and Campbell et al. to obtain the invention as specified in claim 26.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bach (US 4,647,539) (already of record) in view of Campbell et al. (US 2018/0216057 A1) (already of record) as applied to claim 1 above, and further in view of Niazi (US 2017/0191015 A1) (already of record).
Regarding claim 5, Bach teaches a bioreactor chamber comprising a flexible membrane (Fig. 5 middle segment 12), but does not teach wherein the flexible membrane is less than 100 microns thick. However, Niazi teaches bioreactor walls that are less than 100 microns thick (para. 0043 “less than or equal to 3 mils”). Niazi discloses that 1 mil is 25.4 micrometers (para. 0043), thus, “less than or equal to 3 mils” can be read as less than or equal to 76.2 micrometers, which overlaps the claimed less than 100 microns. Niazi teaches that the wall thickness is suitable for retaining culture medium within and have a certain resistance to puncturing during operation or handling (para. 0043). It would have been obvious to a person of ordinary skill in the art to use the Niazi configuration of a membrane that is less than 100 microns thick in Bach’s device with a reasonable expectation that it would be suitable for retaining culture medium within and have a certain resistance to puncturing during operation or handling. This method for improving Bach’s device was within the ability of one of ordinary skill in the art based on the teachings of Niazi. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bach and Niazi to obtain the invention as specified in claim 5.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Bach (US 4,647,539) (already of record) in view of Campbell et al. (US 2018/0216057 A1) (already of record) as applied to claim 1 above, and further in view of Hori et al. (US 2021/0238528 A1) (already of record).
Regarding claim 11, Bach teaches a bioreactor chamber comprising a substrate that extends between the first end block and the second end block (Fig. 5 capillaries 34), and wherein the substrate can be made from cellulose acetate, polysulfone, or acrylic copolymers (Col. 3, lines 63-64), but does not teach wherein the substrate comprises a scaffold.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bach (US 4,647,539) (already of record) in view of Campbell et al. (US 2018/0216057 A1) (already of record) as applied to claim 1 above, and further in view of Hakimi et al. (WO 2015/049524 A1) (already of record).
Regarding claim 13, Bach teaches a bioreactor chamber comprising a substrate comprised of a plurality of substantially aligned filaments (Fig. 5 capillaries 34), but does not teach wherein the substrate comprises a scaffold and wherein the scaffold comprises a plurality of substantially aligned electrospun filaments. However, Hakimi et al. teaches a scaffold comprising a plurality of substantially aligned electrospun filaments (p. 1 “electrospinning… aligned scaffolds”). Hakimi et al. teaches that electrospinning allows entrapment of growth factors or vitamins during the production of the scaffold (p. 8, lines 27-29). It would have been obvious to a person of ordinary skill in the art to use the Hakimi et al. configuration of a scaffold comprising a plurality of substantially aligned electrospun filaments in Bach’s device with a reasonable expectation that it would allow entrapment of growth factors or vitamins during the production of the scaffold. This method for improving Bach’s device was within the ability of one of ordinary skill in the art based on the teachings of Hakimi et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bach and Hakimi et al. to obtain the invention as specified in claim 13.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Guertin et al. (US 9,127,242 B2) discloses a bioreactor for cultivating graft tissue including a scaffold within the bioreactor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799