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 .
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(s) 9, 12 and 15 is/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.
Claim 9 introduces two different cells in the gel, however it is unclear if these cells are in addition to or comprised in the “retinal cells” of claim 1. For the sake of Examination, it is being interpreted that the two different cells of claim 9 as being comprised in the “retinal cells” of claim 1. Therefore, Applicant is suggested to amend claim 9 to recite “wherein the gel comprises a first basal layer where the retinal cells comprise where the retinal cells comprise
Regarding claim 12, claim 1 requires the gel be deposited in the first target area and claim 10 requires that the gel is cut prior to aspirating. However, claim 12 renders the following things unclear:
Is the “aspirating” of claim 12 the same “aspirating” step of claim 1? If the aspirating steps are same, then it is required for the gel of claim 1 to be a ribbon. However, if the gel of claim 1 is a ribbon, then it is unclear if the ribbon of claim 1 is the same as the “one or more ribbons” of claim 12. If yes, then the first ribbon is required to be deposited in the first target area, but claim 12 appears to allow it to actually be deposited at a second target area – which would result in a 112(d) issue since it would be removing one of the requirements of claim 1.
It is unclear if claim 12 is specifying that a different one of the ribbons (not the one of claim 1) can be deposited at the first target area (in addition to the one of claim 1) or at a second target area.
For the sake of examination, claim 12 is interpreted to specify that:
the gel of claim 1 is a ribbon and that ribbon is required to be deposited in the first target area.
the method allows for a second ribbon to be deposited either at the first target area or a second target area.
Claim 15 recites “further comprising depositing the gel in a sub-retinal space of the patient’s eye”. However, it is unclear if claim 15 is intended to define the “first target area” of claim 1 as being the “sub-retinal space” or appear to be an additional step to the “depositing the gel in a first target area of the patient’s eye” (due to reciting “further comprising in claim 15) and requiring two depositing actions and requiring the sub-retinal space to be different from the “first target area”. For the sake of Examination and in light of the Specification, claim 15 is intended to define the “first target area” of claim 1 as being the “sub-retinal space”. Therefore, Applicant is suggested to amend claim 15 to recite “wherein depositing the gel in the first target area of the patient’s eye comprises depositing the get in a sub-retinal space of the patient’s eye”, to overcome rejection.
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 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.
Claim(s) 1, 3 and 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Golestaneh (US 20140341965 A1).
Regarding claim 1, Golestaneh discloses a method of implanting retinal cells into a patient's eye (methods to transplant into the subject retinal pigment epithelial (RPE) cells [0008]), comprising:
combining retinal cells and a biodegradable polymer scaffold (scaffolds are rolled with adherent iPSC-RPE cells [0036]) to form a gel (the scaffold supporting the RPE cells comprises gelatin [0020]);
aspirating at least a portion of the gel into a first cannula (the scaffold with iPSC-RPE cells is injected via microvolume syringe from a capillary glass tube [0036]; it is interpreted that the syringe aspirates the gel out of the capillary tube);
forming an incision (an incision is made [0036]) in a sclera of the patient's eye (in the lateral posterior sclera [0036]);
inserting the first cannula through the incision in the sclera of the patient's eye (through this sclerotomy the scaffolds are injected [0036]; it is interpreted the syringe is inserted through this sclerotomy prior to injection of scaffolds); and
depositing the gel in a first target area of the patient's eye (scaffolds are injected and unrolled, taking care to position them into subretinal space [0036]).
Regarding claim 3, Golestaneh disclosed all limitation of claim 1. Golestaneh further discloses wherein the retinal cells are selected from a group consisting of retinal pigment epithelial cells, rod cells, cone cells, horizontal cells, bipolar cells, amacrine cells, retinal ganglion cells, and a combination thereof (it is set forth in [0036] that retinal pigment epithelial cells (iPSC-RPE cells) is injected with scaffold into the eye).
Regarding claim 13, Golestaneh disclosed all limitations of claim 1. Golestaneh further discloses wherein the biodegradable polymer scaffold comprises a material selected from a group consisting of poly(lactic-co-glycolic acid) (PLGA), collagen, gelatin, polycation poly(allylanion hydrochloride) (PAH), polyanion (polyacrylic acid) (PAA), polycation poly(styrene sulfonate) (PSS), polyglycolide, poly(glycolide-co-caprolactone), poly(glycolide-co- trimethylene carbonate), polycaprolactone (PCL), polyurethane (PU), polypropylene carbonate, polyglycolic acid, polyhydroxybutyrate, polylactic acid, polydioxanone, chitosan, laminin, glycosaminoglycan, proteoglycan, heparin, elastin, fibrin, fibronectin, chondroitin sulphate proteoglycan, thiolated collagen, thiolated laminin; thiolated fibronectin, thiolated heparin, thiolated hyaluronic acid, thiolated hyaluronan-collagen-fibronectin, cellulose, hydroxyapatide, calcium phosphate, and combinations thereof (scaffold supporting the RPE cell is fabricated using poly(lactic-co-glycolic acid) (PLGA) [0020]).
Regarding claim 14, Golestaneh disclosed all limitations of claim 13. Golestaneh further discloses wherein the biodegradable polymer scaffold comprises PLGA (scaffold supporting the RPE cell is fabricated using poly(lactic-co-glycolic acid) (PLGA) [0020]).
Regarding claim 15, Golestaneh disclosed all limitations of claim 1. Golestaneh further discloses comprising depositing the gel in a sub-retinal space of the patient's eye (scaffolds are injected and unrolled, taking care to position them into subretinal space [0036])
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 2, 4 and 5 is/are rejected under 35 U.S.C.103 as being unpatentable over Golestaneh (US 20140341965 A1) and in further view of Paulsen (US 20260043008 A1).
Regarding claim 2, Golestaneh disclosed all limitations of claim 1. However, Golestaneh failed to explicitly disclose wherein the retinal cells are selected from a group consisting of differentiated cells, progenitor cells, precursor cells, and a combination thereof.
However Paulsen teaches cell transplantation into the eye of a subject, the cell selected comprising RPE progenitor cells [0145]. One of ordinary skill in the art teaches the method of Golestaneh is to be configured to select progenitor cell as the retinal cell.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Golestaneh to include wherein the retinal cells are selected from a group consisting of differentiated cells, progenitor cells, precursor cells, and a combination thereof as taught by Paulsen since such a modification enables the method of Golestaneh to use cells with greater post-thaw viability and growth [Paulsen, 0004].
Regarding claim 4, Golestaneh disclosed all limitations of claim 1. Golestaneh however failed to explicitly disclose wherein the retinal cells comprise differentiated retinal pigment epithelial cells.
However, Paulsen teaches RPE cells are stable, terminally differentiated RPE cells [0153]. One of ordinary skill in the art teaches the method of Golestaneh is to be configured for retinal cells to comprise differentiated retinal pigment epithelial cells.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Golestaneh to include wherein the retinal cells comprise differentiated retinal pigment epithelial cells as taught by Paulsen since such a modification enables the method of Golestaneh to use cells with greater post-thaw viability and growth [Paulsen, 0004].
Regarding claim 5, Golestaneh disclosed all limitations of claim 1. However, Golestaneh failed to explicitly disclose wherein the retinal cells comprise photoreceptor progenitor cells.
However Paulsen teaches cell transplantation into the eye of a subject, the cell selected comprising photoreceptor progenitor cells [0145]. One of ordinary skill in the art teaches the method of Golestaneh is to be configured to select photoreceptor progenitor cell as the retinal cell.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method of Golestaneh to include wherein the retinal cells comprise photoreceptor progenitor cells as taught by Paulsen since such a modification enables the method of Golestaneh to use cells with greater post-thaw viability and growth [Paulsen, 0004].
Claims 6 is/are rejected under 35 U.S.C.103 as being unpatentable over Golestaneh (US 20140341965 A1) and in further view of Paulsen (US 20260043008 A1) and Wu (US 20240252687 A1).
Regarding claim 6, Golestaneh as modified by Paulsen disclosed all limitations of claim 5. However Golestaneh as modified by Paulsen failed to explicitly disclose wherein the photoreceptor progenitor cells comprise rod progenitor cells, cone progenitor cells, or a combination thereof.
However, Wu teaches the terminally differentiated cells include retinal pigment epithelial cells, cone cells, rod cells, photoreceptor progenitor cells [0074]. One of ordinary skill in the art recognizes the combination as taught by Wu combines photoreceptor progenitor cells, rod cells and cone cells as required by claim 6 and teaches the cell of Golestaneh is to be configured to be the combination of cells as taught by Wu.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method Golestaneh as modified by Paulsen to include wherein the photoreceptor progenitor cells comprise rod progenitor cells, cone progenitor cells, or a combination thereof as taught by Wu since such a modification enables the method of Golestaneh to transplant cells to treat wet age-related macular degeneration [Wu, 0006].
Claims 7 is/are rejected under 35 U.S.C.103 as being unpatentable over Golestaneh (US 20140341965 A1) and in further view of Wu (US 20240252687 A1).
Regarding claim 7, Golestaneh disclosed all limitations of claim 1. However, Golestaneh failed to explicitly disclose wherein the retinal cells comprise differentiated retinal pigment epithelial cells, rod progenitor cells, and cone progenitor cells.
However, Wu teaches the terminally differentiated cells include retinal pigment epithelial cells, cone cells, rod cells, progenitor cells [0074]. One of ordinary skill in the art teaches the retinal cell of Golestaneh to be configured to include a combination of different cells as taught by Wu.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method Golestaneh to include wherein the retinal cells comprise differentiated retinal pigment epithelial cells, rod progenitor cells, and cone progenitor cells as taught by Wu since such a modification enables the method of Golestaneh to to transplant cells to treat wet age-related macular degeneration [Wu, 0006].
Claims 8 is/are rejected under 35 U.S.C.103 as being unpatentable over Golestaneh (US 20140341965 A1) and in further view of Dias (US 20140377326 A1).
Regarding claim 8, Golestaneh disclosed all limitations of claim 1. However, Golestaneh failed to explicitly disclose wherein depositing a double layer of gels by:combining additional retinal cells and a second biodegradable polymer scaffold to form a second gel; aspirating at least a portion of the second gel into the first cannula or a second cannula; inserting the first cannula or the second cannula through the incision in the sclera of the patient's eye; and depositing the second gel in the first target area or a second target area of the patient's eye.
However, Dias teaches a bilayer cell composition comprising distinct photoreceptor precursor cells (PRP) and polarized retinal epithelial cells (RPE) [0038].
Dias further teaches the RPE and PRP is co-cultured on a PLGA scaffold [0237]. One of ordinary skill in the art teaches the method of Golestaneh to be configured to compose a bilayer of distinct cells on a scaffold to form a double layer of gel as taught by Dias.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method Golestaneh to include wherein depositing a double layer of gels by:combining additional retinal cells and a second biodegradable polymer scaffold to form a second gel; aspirating at least a portion of the second gel into the first cannula or a second cannula; inserting the first cannula or the second cannula through the incision in the sclera of the patient's eye; and depositing the second gel in the first target area or a second target area of the patient's eye as taught by Dias since such a modification enables the method of Golestaneh to provide potential opportunity to treat conditions of either RPE or photoreceptor dysfunction [Dias, 0005].
Claim 9 is/are rejected under 35 U.S.C.103 as being unpatentable over Golestaneh (US 20140341965 A1) and in further view of Dias (US 20140377326 A1), Sugita (US 20240207483 A1) and Roy (US 20230043556 A1).
Regarding claim 9, Golestaneh disclosed all limitations of claim 1. Golestaneh however failed to explicitly disclose wherein the gel comprises a first basal layer comprising differentiated retinal pigment epithelial cells and a second apical layer comprising photoreceptor progenitor cells.
However, Dias teaches a bilayer cell composition comprising distinct photoreceptor precursor cells (PRP) and polarized retinal epithelial cells (RPE) [0038]. Dias further teaches differentiated retinal epithelial cells [150].
Further, Sugita teaches that photoreceptor progenitor cells are expressed in layers in the apical surface side in a culture [0256].
Furthermore, Roy teaches differentiated epithelial cells form a basal layer [0065]. One of ordinary skill in the art teaches the method of Golestaneh as modified by Dias is to be configured to have differentiated retinal pigment epithelial cells form a basal layer as taught by Roy and photoreceptor progenitor cells form an apical layer as taught by Sugita.
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method Golestaneh as modified by Dias to include wherein the gel comprises a first basal layer comprising differentiated retinal pigment epithelial cells and a second apical layer comprising photoreceptor progenitor cells as taught by Roy and Sugita since such a modification enables the method of Golestaneh to provide potential opportunity to treat conditions of either RPE or photoreceptor dysfunction [Dias, 0005].
Claims 10 and 11 is/are rejected under 35 U.S.C.103 as being unpatentable over Golestaneh (US 20140341965 A1) and in further view of Niu (US 20140377326 A1).
Regarding claim 10, Golestaneh disclosed all limitations of claim 1. However, Golestaneh failed to explicitly disclose further comprising cutting the gel into one or more ribbons prior to aspirating the gel into the first cannula.
However, Niu teaches a transparent hydrogel scaffold carrying endothelial cell layer for transplantation into the eye is a sheet, which can be used after cutting into a size suitable for the application site during the transplantation [0118]. One of ordinary skill in the art teaches the gel of Golestaneh is to be configured to be cut prior to application as taught by Niu.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method Golestaneh to include comprising cutting the gel into one or more ribbons prior to aspirating the gel into the first cannula as taught by Niu since such a modification enables the method of Golestaneh to deliver the gel into smaller areas [Niu, 0117].
Regarding claim 11, Golestaneh as modified by Niu disclosed all limitations of claim 10. However, Golestaneh failed to explicitly disclose wherein the one or more ribbons have a substantially rectangular cross-sectional area.
However, Niu teaches the hydrogen scaffold sheet is cut and rolled into a disc shape [0118].
It would have been obvious to one ordinary skill in the prior to the effective filing date of the invention to modify the method of Golestaneh to cut the gel into a shape as taught by Niu since it has been held “that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929). See MPEP 2144.05.11.A.
In the instant case, the shape of the gel ribbon Golestaneh as modified by Niu would not operate differently since the cut hydrogels of Niu is configured to be delivered into the eye. Furthermore, Applicant places no criticality on the shape of the ribbon in paragraph [00038] which specifies other shapes are contemplated including various three-dimensional shapes.
Claims 12 is/are rejected under 35 U.S.C.103 as being unpatentable over Golestaneh (US 20140341965 A1) and in further view of Niu (US 20140377326 A1) and Sheikhi (US 20210403649 A1).
Regarding claim 12, Golestaneh as modified by Niu disclosed all limitations of claim 10. However Golestaneh as modified by Niu failed to explicitly disclose comprising depositing the one or more ribbons confluently in the first target area or a second target area of the patient's eye.
However, Sheikhi teaches bulk hydrogel based on small scale gel building blocks is deposited as droplets and allowed to chemically anneal into larger connected scaffold at delivery site [0006]. One of ordinary skill in the art recognizes the delivery of gels in bulk as droplets and chemical annealing post delivery requires continuous or confluent delivery of gel blocks.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the method Golestaneh as modified by Niu to include comprising depositing the one or more ribbons confluently in the first target area or a second target area of the patient's eye as taught by Sheikhi since such a modification enables the method of Golestaneh for controlled delivery of target cells and cargos [Sheikhi, 0004].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 20230363941 A1 (Andino) – related to an apparatus for retinal injection.
US 20130116799 A1 (Derwin) – related to a biocompatible tissue graft.
US 20110004304 A1 (Tao) – related to a scaffold for retinal cells.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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