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 .
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.
Claims 2-7, and 12-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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.
The term “preferable” or “more preferable” in claims 2-7, 12-13 and 15 is a relative term which renders the claim indefinite. The term “preferable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term preferably renders the claim indefinite as it is not clear if the components recited after the term are required by the claim, or not therefore the metes and bounds of the claim are not clear. For examination purposes the terms are being treated as not required by the claims. Claim 14 is rejected as being dependent on claim 13.
Regarding claim 7, the phrase " blastocyst-like organoid” in parenthesis, renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "- like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Further it is not clear if the terms in the parenthesis (embryonic organoid), and (blastocyst-like organoid), are required by the claim.
Regarding claim 13, the claim depends on claim 1, however it recites “positioning a bottom membrane”, “a support structure”, “a mesh”, “a top membrane”, an inner space, a central space, etc. These limitations are part of the device of claim 1, it is not clear if the claim requires a second bottom membrane, second support structure, or if these limitations are the same as in claim 1. For examination purposes the limitations have been interpreted as being the same as in claim 1. Claims 14-15 are rejected as being dependent on claim 13.
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.
Claim(s) 1-2, 5-7,and 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brauker et al. (US 5314471 A) hereinafter Brauker in view of Dalton (US 20170007808).
Regarding claim 1, Brauker teaches an implantable device of the immunoprotective type for implanting cells or cell aggregates in a subject, wherein the device comprises:
a bottom membrane (32) and a top membrane (34),
wherein the bottom membrane and the top membrane are joined together with a support structure (14) such that the bottom membrane, top membrane and the support structure form an enclosed inner space not accessible by the immune system when implanted, and
wherein the bottom membrane and the top membrane comprise a plurality of pores extending through the membrane to allow diffusion of nutrients and oxygen to the inner space (col. 5, lines 40-49), and
wherein the device is characterized by the presence of a mesh (36, col. 6, line 33) positioned in the inner space of the device such as to provide a support for cells or cell aggregates when the cells or cell aggregates are comprised in the inner space of the device, such that the cells do not clump,
Brauker fails to explicitly teach the mesh (36) has a pore dimension between 60 and 300 µm.
Dalton teaches a chamber for encapsulating cells having a mesh (Refer to paragraph [0015]) and that the pore size of the mesh is selected to protect the interior of the chamber from tissue invasion. Thus, the pore size is a result-effective variable because it affects the performance of the mesh in supporting cells and preventing invasion.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to select the pore size of the mesh of Brauker to be between 60-300 µm depending on the cells used, as taught by Dalton to achieve the predictable result of protect the interior chamber from tissue invasion.
Regarding claim 2, Brauker teaches the bottom membrane and/or the top membrane and optionally the support structure are made from a non-water soluble polymer, preferable of polyvinylidene fluoride (PVDF, See table 1, col. 14), polyethersulfone (PES), poly(ethylene oxide terephthalate)/poly(butylene terephthalate) (PEOT/PBT) or PVDF mixed with a water soluble co-polymer, preferably wherein the membranes further comprise a pore forming reagent, more preferably wherein the pore forming reagent is polyvinylpyrrolidone (PVP).
Regarding claim 5, modified Brauker fails to teach wherein the mesh is constructed from a non- degradable polymer, preferably wherein the non-degradable polymer is selected from nylon, PVDF, PTFE, PP, PE, or PET. Dalton teaches the mesh made of PTFE, or PE (refer to paragraph 0034]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to select the mesh material of Brauker to be PTFE or PE, as taught by Dalton to allow optimal conditions for cell growth within the device.
Regarding claim 6, modified Brauker fails to explicitly teach wherein the mesh has a pore dimension of between 60 and 200 µm, preferably between 70 and 150 µm, more preferably between 75 and 120 µm.
Dalton teaches a chamber for encapsulating cells having a mesh (Refer to paragraph [0015]) and that the pore size of the mesh is selected to protect the interior of the chamber from tissue invasion. Thus, the pore size is a result-effective variable because it affects the performance of the mesh in supporting cells and preventing invasion.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to select the pore size of the mesh of Brauker to be between 60-200 µm depending on the cells used, as taught by Dalton to achieve the predictable result of protect the interior chamber from tissue invasion.
Regarding claim 7, modified Brauker teaches wherein the device comprises cells in the inner space, preferably wherein the cells are cell aggregates and/or organoids, preferable wherein the cell aggregates are endocrine cells or cytokine producing cells or aggregates thereof, preferably wherein the cell aggregates are selected from islet cells, human mesenchymal stem cells, kidney cells, thyroid cells, thymic cells, testicular cells, pancreatic cells (refer to col. 5, lines 37-39), endocrine cells, liver cells, cytokine producing cells, or preferably wherein the organoid is selected from a kidney organoid, an intestinal organoid, a pancreatic organoid, a neural organoid, a hepatic organoid, a thyroid organoid, a stomach organoid, an ovarian organoid, a prostate organoid, a splenic organoid, oesophageal organoid, a breast organoid, a bladder organoid, a lung organoid, an optic organoid, an inner ear organoid, a cardiac organoid, a biliary organoid, a salivary gland organoid, a pituitary gland organoid, a lymphoid organoid, a bladder organoid, a tongue organoid, a cerebral/brain organoid, a spinal cord organoid, a fallopian tube organoid, a lacrimal gland organoid, a skin organoid, a thymic organoid, a testicular organoid, an epithelial organoid, a gastruloid (embryonic organoid), a blastoid (blastocyst-like organoid), a retinal organoid and a hippocampal organoid.
Regarding claim 9, modified Brauker teaches for use as a medicament, wherein the implantable device comprises cells (col. 5, lines 37-39). ((Note: The examiner is considering the italicized text as a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.)
Regarding claim 10, modified Brauker teaches for use in the treatment of diabetes (Col. 5, lines 37-39), wherein the implantable device comprises pancreatic islet cells (col. 5, lines 37-39) or cells engineered to secrete insulin ((Note: The examiner is considering the italicized text as a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.)
Regarding claim 11, modified Brauker teaches the device is capabe to be used for in the treatement of diabetes, wherein the diabetes is type 1 diabetes (Col. 5, lines 37-39). (Note: The examiner is considering the italicized text as a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.)
Regarding claim 12, modified Brauker teaches the use comprises implanting the device in a subject in need thereof ((Col. 5, lines 37-39), preferably wherein the implanting is at an extrahepatic site (outside the liver). (Note: The examiner is considering the italicized text as a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.)
Regarding claim 13, modified Brauker teaches the method comprising:
providing a bottom membrane (32);
positioning a support structure (14) roughly along the edges of the bottom membrane such as to leave a central space (see Figure 3);
positioning a mesh (36) in the central space on top of the bottom membrane;
positioning a top membrane (34) on top of the support structure such as to cover the central space comprising the mesh as to completely enclose it creating an inner space; and fixing the top and bottom membrane to the support structure,
preferably by ultrasonic welding, heat sealing, pressure sealing (Refer to col. 6, lines 52-60). “To complete the assembly 10, the practitioner presses the second hoop element 16 through the second central opening 24 into pressing engagement against the adjacent wall element 34. This seals the periphery of the cell holding chamber 18, which now snugly rests within the open area of the hoop-like housing 11), adhesives or more preferable by ultrasonic welding.
Regarding claim 14, modified Brauker teaches wherein the top and bottom membranes are fixed to the support structure such as to leave a single opening (38) for loading the device with cells (Col. 6, lines 40-51) opening 38 is open to load the cells, then the top membrane is fixed to the bottom membrane).
Regarding claim 15, modified Brauker teaches
providing a cell suspension in a container (inherent to hold cells);
connecting a tube (see Figure 5) such that one end is in open contact with the interior of the container with the cell suspension, and that the other end is inserted through an opening into the inner space of the implantable device (see Figure 5); and
allowing the cells in the container to drain through the tube into the inner space of the implantable device (see Figure 5); and optionally closing the opening in the implantable device after removing the tube, preferably by ultrasonic welding, heat sealing, pressure sealing, adhesives or more preferable by heat sealing (this limitation is a contingent limitation, see MPEP 2111.04, II).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brauker et al. (US 5314471 A) hereinafter Brauker in view of Dalton (US 20170007808), as applied to claim 1 above, and further in view of Cully et al. (US 20210022846) hereinafter Cully.
Regarding claim 3, modified Brauker fails to explicitly teach the pore size of the bottom membrane and the top membrane is between 10 and 500 nm, preferably between 50 and 450 nm more preferably between 100 and 400 nm.
Cully teaches a top and bottom membrane (inner membranes 214/224) the pore size of the bottom membrane and the top membrane is between 10 and 500 nm, preferably between 50 and 450 nm more preferably between 100 and 400 nm (“The average pore size of the inner porous layer may be less than about 5 microns, less than about 1 micron, less than about 0.8 microns, less than about 0.5 microns, less than about 0.3 microns, or less than about 0.1 micron, as measured by porometry. A small pore size allows the inner porous layer to function as a cell retentive layer to keep cells disposed in the chamber inside the cell encapsulation device, yet allows nutrients and other biomolecules to enter and cell waste and therapeutic products to exit”. Refer to paragraph [0056]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to select the pore size of the membrane of Brauker to be between 10 and 500 nm, as taught by Cully to allow optimal conditions for cell growth within the device.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brauker et al. (US 5314471 A) hereinafter Brauker in view of Dalton (US 20170007808), as applied to claim 1 above, and further in view of Zhang et al. (US 20110042299) hereinafter Zhang.
Regarding claim 4, modified Brauker fails to explicitly teach wherein the bottom membrane and the top membrane have a thickness of between 10 and 200 nm, preferably between 35 and 200 nm, more preferably between 40 and 160 nm.
Zhang teaches the use of a polyvinylidene fluoride membrane, having a thickness of between 10 and 200 nm (see paragraph [0022]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to select a membrane thickness between 10 and 200 nm as the thickness on the membranes of Brauker, as taught by Zhang, to facilitate the passage of nutrients and fluids, while allowing protection.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closest art of record Brauker, Dalton and Cully, do not teach two or more devices stacked together and separated by spacer.
Conclusion
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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