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 Amendment
The 112b rejections made in the previous action are withdrawn in view of amendments.
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 1, 6-11, 13-15, 17-18, 24-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 1 line 4 recites “wherein at least one microwell - and preferably all microwells” and is unclear if the limitation of “preferably all microwells” is positively recited (see MPEP 2173.05(d)). For prosecution, the limitation will be interpreted to mean “wherein at least one microwell or all microwells”. Claims 6-11, 13-15, 17-18, 24-28 dependent on claim 1 are also rejected based on said dependency.
Claim 1 lines 13 and 21 recite “and preferably both, of said support pillars” and is unclear if the limitation of “and preferably both” is positively recited (see MPEP 2173.05(d)). For prosecution, the limitation will be interpreted to mean “or both, of said support pillars”.
Claims 10 line 2 recites “the translucent slide” and lacks antecedence. For prosecution, the limitation will be interpreted to depend on claim 7.
Claims 10 line 2 recites “and preferably the support pillars” and is unclear if the limitation following preferably is positively recited (see MPEP 2173.05(d)). For prosecution, the limitation will be interpreted to mean “at least the planar base element and the translucent slide are at least partly transparent to visible light”.
Claim 14 line 3 recite “preferably 3-D printed” and “preferably a compliant polymer matrix” and is unclear if the limitations after preferably are positively recited (see MPEP 2173.05(d)). For prosecution, the limitation will be interpreted to mean “the support pillars and the receptacle are formed from the same polymer matrix”.
Claim 24 line 2 recites “and preferably both support pillars” and is unclear if the limitation is positively recited. For prosecution, the limitation will be interpreted to mean “or the support pillars”.
Claim 29 lines 4 recites “at least one well - and preferably all wells” and unclear if the limitation “preferably all wells” is positively recited. For prosecution, the limitation will be interpreted to mean “wherein at least one microwell”.
Claim 29 lines 13 and 21 recite “at least one, and preferably both, of said support pillars” and unclear if the limitation of “preferably both, of said support pillars” is positively recited. For prosecution, the limitation will be interpreted to mean “wherein at least one support pillar”.
Claim Rejections - 35 USC § 102
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 6, 9, 13-15, 17-18, and 25-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (US20190316068A1 published 10/17/2019; hereinafter Chen).
Regarding claim 1, Chen teaches a contractile tissue-based analysis device (a system for generating 3-dimensional (3D) cardiac tissues – paragraph 6), said contractile tissue-based analysis device comprising a multi-well plate (a system 100 with several wells 112 – Figs. 3A and 12), said multi-well plate having substantially planar upper and lower faces and comprising a plurality of microwells being open at said upper face (the system 100 having substantially planar upper and lower surfaces with the wells 112 being open at the upper surface – Figs. 3A and 12); wherein at least one microwell - and preferably all microwells - of said multi- well plate comprise at least one support structure (a base 110 and a petri dish 114 forming at least one well – Fig. 13A); said support structure comprising:
- a substantially planar base element (the surface of the petri dish 114 holding the base 110 is planar – Figs. 13A-D);
- first and second support pillars (two pillars 250 and 252 with heads 254, 256 – Fig. 13A-D), each support pillar extending from the base element in a direction substantially perpendicular to the plane of the base element (the pillars 250 and 252 perpendicular to the surface of the petri dish 114 – Figs. 13A-D);
wherein each support pillar comprises a stem portion (pillars 250, 252 – Figs. 13A-D) and a head portion (head 254, 256 – Figs. 13A-D), in which each stem portion extends between the base element and each of the head portions (the pillars 250, 252 are between the heads 254, 256 and the surface of the petri dish 114 – Figs. 13A-D);
wherein at least one, and preferably both, of said support pillars can flex along an axis Y-Y extending between the head portions of the pillars (the pillars 250 and 252 with heads 254, 256 are capable of flexing along an axis Y-Y between the pillars – Fig. 13A-D and paragraph 138);
wherein each support structure (100) further comprises a receptacle (a lower chamber 230 – Figs. 13A-D), said receptacle comprising a basewall (a bottom surface 240 of the lower chamber 230 – Figs. 13A-D) and at least one sidewall (a wall 236 of the lower chamber 230 – Figs. 13A-D); and wherein said at least one sidewall extends from said basewall in a direction away from the base element (the wall 236 extend from the bottom surface 240 away from the bottom of the petri dish 114 – Figs. 13A-D) such that the receptacle defines an inner volume (a space defined by the lower chamber 230 – Figs. 13A-D), and wherein the head portions are fully located within said inner volume (the pillars 250 and 252 with heads 254, 256 are fully located within the space of the lower chamber 230 – Figs. 13A-D),
said analysis device further comprising an optical detection device (a microscope and camera for individual analysis – paragraph 205), wherein the head portion of at least one support pillar and preferably both support pillars, of each support structure is/are arranged to be detected by said optical detection device (optical tracking methods such as video analysis to find the displacement of the pillars – paragraph 217); and,
said optical detection device being arranged to capture image data from at least one of said head portions (each image taken by a microscope and camera for individual analysis – Fig. 5A and paragraphs 85, 205),
wherein a strip of contractile tissue extends between the head portions of said first and second support pillars of each support structure (a bright field top view image of an iPSC-CM cardiac tissue suspended between two posts with spherical caps – paragraph 85 and Fig. 5A).
Regarding claim 6, Chen teaches the analysis device according to claim 1, further comprising a pair of electrodes connected to a power supply (a set of electrodes 122 that are inserted in the wells 112 and connected to a culture stimulator 120 – paragraph 133 and Fig. 12) and arranged to apply electrical stimulation to the strip of contractile tissue (the set of electrodes 122 provide electrical signals to stimulate tissue generation – paragraph 133 and Fig. 12).
Regarding claim 9, Chen teaches the analysis device according to claim 1, wherein said axis Y-Y is arranged substantially parallel to the plane of said base element (the axis Y-Y between the pillars is parallel with the base of the petri dish – Fig. 13A-D and paragraph 138).
Regarding claim 13, Chen teaches the analysis device according to claim 1, further comprising at least one dosing means for providing at least one drug to said strip of contractile tissue (a pipette is capable of being used to for providing a drug to the cardiomyocytes – paragraph 155).
Regarding claim 14, Chen teaches the analysis device according to claim 1, wherein the base element, the support pillars and the receptacle are formed, preferably 3-D printed, from the same polymer matrix, preferably a compliant polymer matrix (the device is made of poly(ethylene glycol) and is least partly transparent to visible light – paragraph 98).
Regarding claim 15, Chen teaches the analysis device according to claim 1, wherein said device comprises a plurality of support structures arranged in a planar array (six final PDMS tissue platforms, each featuring a 2×3 array of microwells each is then adhered to a 35 mm petri dish – paragraph 381 and Fig. 4B); wherein the planar base elements of all support structures in the array are substantially co-planar in the plane of the array (the 35 mm petri dishes are attached to the tissue platforms and are thus all planar to the array of tissue platforms – paragraph 381 and Fig. 4B); and, wherein the support pillars of all support structures in the array are arranged on the same face of the planar array (the pillars all point upward from the bottom of the tissue platforms and are thus all on the same face of the planar array of tissue platforms – paragraph 381 and Fig. 4B).
Regarding claim 17, Chen teaches the analysis device according to claim 15, wherein a single optical detection device is arranged on the side of the planar array opposite to the support pillars (each image taken by a microscope and camera for individual analysis – Fig. 5A and paragraphs 85, 205), the optical detection device being moveable in the plane of the array (the microscope and camera are capable of moving in the plane of the array of tissue platforms – Fig. 5A and paragraphs 85, 205).
Regarding claim 18, Chen teaches the analysis device according to claim 15, comprising a plurality of optical detection devices arranged on the side of the planar array opposite to the support pillars (the microscope and camera comprising a plurality of optical detection devices – paragraph 205), wherein each optical detection device is arranged to capture image data from at least one of the head portions of the first and second support pillars of each support structure (the microscope and camera are each capable of being used to capture image data of the head 254, 256 – paragraphs 205, 217).
Regarding claim 25, Chen teaches the analysis device according to claim 14, wherein the base element, the support pillars and the receptacle are 3-D printed, from a hydrogel polymer matrix (“the base element, the support pillars and the receptacle are 3-D printed from a hydrogel polymer matrix” is a product by process limitation. If the product in the product-by-process claim is the same as a product of the prior art, the claim is unpatentable even though the prior product was made by a different process; see MPEP2113) (Non-limiting examples of polymers and elastomers can be hydrogels such as gelatin, alginate, agarose, polyethylene glycol (PEG) – paragraph 148)
Regarding claim 26, Chen teaches the analysis device according to claim 25, wherein the base element, the support pillars and the receptacle are 3-D printed from a poly(ethylene glycol)-based polymer matrix (“the base element, the support pillars and the receptacle are 3-D printed from a poly(ethylene glycol)-based polymer matrix” is a product by process limitation. If the product in the product-by-process claim is the same as a product of the prior art, the claim is unpatentable even though the prior product was made by a different process; see MPEP2113) (the device is made of poly(ethylene glycol) and is least partly transparent to visible light is deemed to read on the limitation even though the prior product was made by a different process – paragraph 98).
Regarding claim 27, Chen teaches the analysis device according to claim 1, wherein the receptacle is arranged to support stem cells, contractile progenitor cells, or contractile tissue cells (“to support stem cells, contractile progenitor cells, or contractile tissue cells” is a material worked upon by the apparatus, and per MPEP 2115 inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims) (a bright field top view image of an iPSC-CM cardiac tissue suspended between two posts with spherical caps – paragraph 85 and Fig. 5A) as well as relevant stromal cells in their growth medium and gel forming components prior to contractile tissue formation on the head portions of each support pillar (“stromal cells in their growth medium and gel forming components” is a material worked upon by the apparatus, and per MPEP 2115 inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims) (the limitation is deemed to read on a receptacle capable of stromal cells and the lower chamber 230 is capable of holding relevant stromal cells – Figs. 13A-D).
Regarding claim 28, Chen teaches the analysis device (200) according to claim 1, wherein the optical detection device is a video camera (optical tracking methods such as video analysis – paragraph 217).
Regarding claim 29, Chen teaches a contractile tissue-based analysis device (a system for generating 3-dimensional (3D) cardiac tissues – paragraph 6), the device comprising a multi-well plate (a system 100 with several wells 112 – Figs. 3A and 12), the multi-well plate having substantially planar upper and lower faces and comprising a plurality of wells being open at the upper face (the system 100 having substantially planar upper and lower surfaces with the wells 112 being open at the upper surface – Figs. 3A and 12); wherein at least one well - and preferably all wells - of the multi-well plate comprise at least one support structure (a base 110 and a petri dish 114 forming at least one well – Fig. 13A); the support structure comprising:
- a substantially planar base element (the surface of the petri dish 114 holding the base 110 is planar – Figs. 13A-D);
- first and second support pillars (two pillars 250 and 252 with heads 254, 256 – Fig. 13A-D), each support pillar extending from the base element in a direction substantially perpendicular to the plane of the base element (the pillars 250 and 252 perpendicular to the surface of the petri dish 114 – Figs. 13A-D);
wherein each support pillar comprises a stem portion (pillars 250, 252 – Figs. 13A-D) and a head portion (head 254, 256 – Figs. 13A-D), in which each stem portion extends between the base element and each of the head portions (the pillars 250, 252 are between the heads 254, 256 and the surface of the petri dish 114 – Figs. 13A-D);
wherein at least one, and preferably both, of the support pillars can flex along an axis Y-Y extending between the head portions of the pillars (the pillars 250 and 252 with heads 254, 256 are capable of flexing along an axis Y-Y between the pillars – Fig. 13A-D and paragraph 138);
wherein each support structure further comprises a receptacle (a lower chamber 230 – Figs. 13A-D), the receptacle comprising a basewall (a bottom surface 240 of the lower chamber 230 – Figs. 13A-D) and at least one sidewall (a wall 236 of the lower chamber 230 – Figs. 13A-D); and
wherein the at least one sidewall extends from the basewall in a direction away from the base element (the wall 236 extend from the bottom surface 240 away from the bottom of the petri dish 114 – Figs. 13A-D) such that receptacle defines an inner volume (a space defined by the lower chamber 230 – Figs. 13A-D), and wherein the head portions are fully located within the inner volume (the pillars 250 and 252 with heads 254, 256 are fully located within the space of the lower chamber 230 – Figs. 13A-D),
the analysis device further comprising an optical detection device (a microscope and camera for individual analysis – paragraph 205), wherein the head portion of at least one support pillar, and preferably both support pillars, of each support structure is/are arranged to be detected by the optical detection device (optical tracking methods such as video analysis to find the displacement of the pillars – paragraph 217); and,
the optical detection device being arranged to capture image data from at least one of the head portions wherein a strip of contractile tissue extends between the head portions of the first and second support pillars of each support structure (a bright field top view image of an iPSC-CM cardiac tissue suspended between two posts with spherical caps – paragraph 85 and Fig. 5A);
wherein the base element, the support pillars and the receptacle are formed from a poly(ethylene glycol)-based polymer matrix (the device is made of polymer such as poly(ethylene glycol) (PEG) – paragraph 149);
wherein the receptacle is arranged to support stem cells, contractile progenitor cells, or contractile tissue cells (“to support stem cells, contractile progenitor cells, or contractile tissue cells” is a material worked upon by the apparatus, and per MPEP 2115 inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims) (a bright field top view image of an iPSC-CM cardiac tissue suspended between two posts with spherical caps – paragraph 85 and Fig. 5A) as well as relevant stromal cells in their growth medium and gel forming components (“stromal cells in their growth medium and gel forming components” is a material worked upon by the apparatus, and per MPEP 2115 inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims) prior to contractile tissue formation on the head portions of each support pillar (the limitation is deemed to read on a receptacle capable of stromal cells) (the lower chamber 230 is capable of holding relevant stromal cells – Figs. 13A-D); and wherein the optical detection device is a video camera (optical tracking methods such as video analysis to find the displacement of the pillars – paragraph 217).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 7, 10, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Thavandiran et al (US20150313704A1 published 11/05/2015; hereinafter Thavandiran).
Regarding claim 7, Chen teaches the analysis device according to claim 1.
However, Chen does not teach wherein the support structure of the analysis device comprises a translucent slide arranged on the face of said substantially planar base element opposite to said support pillars and wherein said optical detection device is arranged on the side of the translucent slide opposite to said substantially planar base element.
Thavandiran (Figs. 22(b)-(e)) teaches an analysis device wherein the support structure of said analysis device comprises a translucent slide (a well bottom or base 705 – Figs. 22(b)-(e)) arranged on the face of said substantially planar base element opposite to said support pillars (well bottom or base 705 is on the side of the ramped support structure 710 opposite to retaining structures 715 – Figs. 22(b)-(e)) and wherein said optical detection device is arranged on (“arranged on” is interpreted as an optical detection device that is capable of being placed to at or moved to) the side of the translucent slide opposite to said substantially planar base element (the microwell of the microfabrication platform and/or CMOS camera of the microfabrication platform are/is capable of being positioned such that the CMOS camera is on the side of the well bottom 705 – Figs. 22(b)-(e) and paragraph 306). Thavandiran also teach to the microwell is used with a pre-polymerized matrix that form the tissue construct without contacting the one or more retaining structures so that dead cells and debris, which have settled onto the well bottom, are separated from the tissue construct (paragraph 180).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the substrate, as taught by Chen, with the base 705 and the ramped support structure 710, taught by Thavandiran (Figs. 22(b)-(e)), so that dead cells and debris are separated from the tissue construct. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Chen and Thavandiran teach platforms for growing cardiac tissue.
Regarding claim 10, Chen, modified by Thavandiran, teaches the analysis device according to claim 1 (the claim is interpreted to depend on claim 7; see 112b above), wherein at least the planar base element (the device is made of poly(ethylene glycol) and is least partly transparent to visible light – paragraph 98) and the translucent slide (the base 705 – Thavandiran Figs. 22(b)-(e)) are at least partly transparent to visible light.
Regarding claim 24, Chen teaches the analysis device (200) according to claim 1.
However, Chen does not teach wherein the head portion of at least one support pillar (20, 30), and preferably both support pillars (20, 30), comprises at least one fiducial marker (26, 36) which can be detected by the optical detection device (220); the least one fiducial marker (26, 36) having an extension from the head portion (22, 32) at least in a direction substantially parallel to the plane of the base element (10), wherein the least one fiducial marker (26, 36) being optically discernible by the optical detection device (220); and, the optical detection device (220) being arranged to capture image data from at least one of the least one fiducial markers (26, 36) of the head portions (22, 32).
Thavandiran teaches an analysis device wherein the head portion of at least one support pillar (the posts 410 and 420 each comprising a top half – Fig. 19 and paragraph 18), and preferably both support pillars (see 112b rejection above), comprises at least one fiducial marker (the top half of posts 410 and 420 comprising protuberances 415 and 425 respectively – Fig. 19) which can be detected by the optical detection device (the CMOS camera is capable of capturing the protuberances 415 and 425 – paragraph 306);
the least one fiducial marker having an extension from the head portion at least in a direction substantially parallel to the plane of the base element (each of the protuberances 415 and 425 extend from the top half of posts 410 and 420 in a direction substantially parallel to the substrate – Fig. 19),
wherein the least one fiducial marker being optically discernible by the optical detection device (the CMOS camera is capable of discerning the protuberances 415 and 425 – paragraph 306); and,
the optical detection device being arranged to capture image data from at least one of the least one fiducial markers of the head portions (the CMOS camera is capable of capturing capture image data of the protuberances 415 and 425 – paragraph 306). Thavandiran teaches to use the protuberances 415, 425 for retaining a microtissue construct 400.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the heads 254 and 256, as taught by Chen, with the protuberances 415 and 425, taught by Thavandiran, to retain a microtissue construct 400. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Chen and Thavandiran teach platforms for growing cardiac tissue.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chen.
Regarding claim 8, Chen teaches the analysis device (200) according to claim 1, wherein said head portions are separated from each other along said axis Y-Y a distance less than or equal to 2mm (the pillars are 0.6 mm apart or more – paragraph 335).
The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the portion of distances between 0.6-2mm that corresponds to the claimed range. See MPEP 2144.05(I).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Vunjak-Novakovic et al (US20190031991A1 published 01/31/2019; hereinafter Vunjak).
Regarding claim 11, Chen teaches the analysis device according to claim 1.
However, Chen does not teach wherein the head portion has a three-dimensional teardrop shape, with a substantially spherical body which extends to a vertex and wherein the head portions of each support pillar are arranged such that the vertex of the head portions and the geometric center of each spherical body, are located along said axis Y-Y, and wherein said vertex of each head portion are located inward of each spherical body along said axis Y-Y.
Vunjak teaches a platform for growing cardiac tissue wherein the head portion has a three-dimensional teardrop shape (top portions of a first pillar and a second pillar each having a three-dimensional tear shape – Figs. 2A-D and paragraph 8), with a substantially spherical body which extends to a vertex (each pillar having a substantially spherical side extending to a vertex – Figs. 2A-D) and wherein the head portions of each support pillar are arranged such that the vertex of the head portions and the geometric center of each spherical body, are located along said axis Y-Y (the top portions of the first and second pillars are arranged such that the vertexes and centers of substantially spherical sides lie along the axis Y-Y extending between the pillars – Figs. 2A-D), and wherein said vertex of each head portion are located inward of said geometric centers of each spherical body along said axis Y-Y (the vertexes of the top portions of the first and second pillars are located inward of the spherical sides of the first and second pillars along the axis Y-Y extending between the pillars – Figs. 2A-D; see 112b rejection above). Vunjak teaches also teaches that the first and second pillars may have a cross-sectional tear shape to facilitate tissue attachment (paragraph 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the shapes of heads 254, 256, as taught by Chen, with the three-dimensional tear shapes, taught by Vunjak, to facilitate tissue attachment. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Chen and Vunjak teach platforms for growing cardiac tissue.
Response to Arguments
Applicant’s addition arguments with respect to the 102 and 103 rejections of the claims have been considered, and a new rejection has been made in order to address the amended claim language.
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796