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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 01/03/2023. Claims 2, 4, 18, 20, and 21 are canceled, Claims 1-23 are currently pending and being examined.
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 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.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the inner limiting” in line 1. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “an inner limiting”. Appropriate correction is required.
Claim 3 is objected to because of the following abnormalities: Claim 3 recites “an eye” in line 9. However, “eye” has already been instantiated in line 2. Examiner suggests reciting “the eye”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Claim 12 recites “the vitreous body” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a vitreous body”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Claim 13 recites “the vitreous body” in line 3. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a vitreous body”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: Claim 19 recites “the dye is a vital dye” in line 4. However, vital dye has already been substantiated. Examiner suggests reciting “the vital dye”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: Claim 19 recites “the therapeutic agent” in lines 13, 14, 15, 19, 20, and 21. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a therapeutic agent” in line 13. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: Claim 19 recites “the vitreous body” in line 20 and 23. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a vitreous body” in line 20. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: Claim 19 recites “the vitreous body” in line 20 and 23. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a vitreous body” in line 20. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: Claim 22 recites “the retina” in line 1. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a retina”. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: Claim 22 recites “the choroid” in line 1. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a choroid”. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: Claim 22 recites “the vitreous chamber” in line 3. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a vitreous chamber”. Appropriate correction is required.
Claim 22 is objected to because of the following abnormalities: Claim 22 recites “an eye” in line 8. However, “eye” has already been instantiated in claim 22. Examiner suggests reciting “the”. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: Claim 23 recites “the dye is a vital dye” in line 4. However, vital dye has already been substantiated. Examiner suggests reciting “the vital dye”. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: Claim 23 recites “the vitreous body” in line 20 and 23. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a vitreous body” in line 20. Appropriate correction is required.
Claim 23 is object to because of the following informalities: Claim 23 recites “the retinal disease” in line 27. However, there is lack of antecedent basis for this limitation. Examiner suggests reciting “a retinal disease” in line 27. Appropriate correction is required.
Claim 23 is object to because of the following informalities: Claim 23 recites “the choroidal disease” in line 27. However, there is lack of antecedent basis for this limitation. Examiner suggests reciting “a choroidal disease” in line 27. Appropriate correction is required.
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 6, 14, 19, and 23 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 claims use the term “preferably” and “more preferably” which renders the claim indefinite because it is unclear if the limitations after “more preferably” are required or not.
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, 3, 5, 6, 8-17, 19, 22, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Comander (WO2016/179496).
In reference to independent claim 1, Comander discloses a method of photoporation of the inner limiting membrane (ILM) of an eye in a subject (Comander discloses a method of carrying out a vitrectomy on an eye, using a dye (indocyanine green specifically) on the back of the eye, then using a laser to create small holes on the eye (commonly called photoporation, “photo” means “light”, and “poration” means “forming pores”), thereafter the eye is treated with a therapeutic agent. Example 1, shown on pages 9-10, discloses a version of the process in detail.), wherein the method comprises:
- administering a dye (ICG in the cite below) to a vitreous chamber of the eye of the subject (col 7, lines 26-29 disclose “It would be appreciated by a skilled artisan that that the ILM can be visualized using an ILM-visualization agent. Visualizing the ILM can allow for improved focus on the targeted region without unnecessary damage to the remaining retina or non-targeted regions. Visualization agents include, for example, indocyanine green dye (ICG)”); and
- irradiating at least part of the ILM of the eye of the subject (a laser is a form of radiation), thereby photoporating at least part of the ILM in the subject (page 7, lines 20-25 disclose “The ILM can be removed using any number of known techniques and mechanisms. For example, the ILM can be surgically removed by "peeling" or "stripping" it from the retina, e.g., using forceps or other tools (e.g., 25 gauge ILM forceps, pick, scraper) or using hydro-dissection. In addition, portions of the ILM can be removed by puncturing the ILM, cutting the ILM with, for example, a laser, enzymatically digesting the ILM, or any combination thereof.” Example 1, found on pages 9 and 10 discloses inserting the dye and then performing the photoporation.)
In reference to independent claim 3, Comander discloses a method of treating a retinal disease or a choroidal disease of an eye in a subject (page 4, line 26-30 discloses “The methods described herein also can be used to treat diseases of the inner retina (such as vascular occlusions and diabetic retinopathy), diseases of the optic nerve (such as optic neuropathies and glaucoma), diseases of the anterior portion of the eye (such as corneal endothelial deficiency, cataract, ocular hypertension, and glaucoma)”), wherein the method comprises:
- administering a dye to a vitreous chamber of the eye of the subject (col 7, lines 26-29 disclose “It would be appreciated by a skilled artisan that that the ILM can be visualized using an ILM-visualization agent. Visualizing the ILM can allow for improved focus on the targeted region without unnecessary damage to the remaining retina or non-targeted regions. Visualization agents include, for example, indocyanine green dye (ICG)”);
- irradiating at least part of an inner limiting membrane (ILM) of the eye of the subject (a laser is a form of radiation), thereby photoporating at least part of the ILM (page 7, lines 20-25 disclose “The ILM can be removed using any number of known techniques and mechanisms. For example, the ILM can be surgically removed by "peeling" or "stripping" it from the retina, e.g., using forceps or other tools (e.g., 25 gauge ILM forceps, pick, scraper) or using hydro-dissection. In addition, portions of the ILM can be removed by puncturing the ILM, cutting the ILM with, for example, a laser, enzymatically digesting the ILM, or any combination thereof.”); and
- administering a therapeutic agent to the vitreous chamber of the eye of the subject, thereby treating the retinal disease or the choroidal disease in the subject (page 4, lines 26-32 discloses “The methods described herein also can be used to treat diseases of the inner retina (such as vascular occlusions and diabetic retinopathy), diseases of the optic nerve (such as optic neuropathies and glaucoma), diseases of the anterior portion of the eye (such as corneal endothelial deficiency, cataract, ocular hypertension, and glaucoma), inflammatory diseases of the eye (such as uveitis, ocular trauma, and ocular infections), and neoplastic diseases of the eye (such as choroidal tumors, epithelial tumors, and metastatic disease).”); or wherein the method comprises:
- administering the dye and the therapeutic agent to the vitreous chamber of an eye of the subject; and irradiating at least part of the ILM of the eye of the subject (a laser is a form of radiation), thereby photoporating at least part of the ILM (Comander discloses a method of carrying out a vitrectomy on an eye, using a dye (indocyanine green specifically) on the back of the eye, then using a laser to create small holes on the eye (commonly called photoporation, “photo” means “light”, and “poration” means “forming pores”), thereafter the eye is treated with a therapeutic agent. Example 1, shown on pages 9-10, discloses a version of the process in detail.) and treating the retinal disease or the choroidal disease in the subject (disclosed in page 4, lines 26-32 above).
In reference to independent claim 22, Comander discloses a method for delivering a therapeutic agent to the retina or the choroid of an eye in a subject, the method comprising:
- administering a dye (ICG in the cite below) to the vitreous chamber of the eye of the subject (col 7, lines 26-29 disclose “It would be appreciated by a skilled artisan that that the ILM can be visualized using an ILM-visualization agent. Visualizing the ILM can allow for improved focus on the targeted region without unnecessary damage to the remaining retina or non-targeted regions. Visualization agents include, for example, indocyanine green dye (ICG)”);
- irradiating at least part of an inner limiting membrane (ILM) of the eye of the subject (a laser is a form of radiation), thereby photoporating at least part of the ILM (Comander discloses a method of carrying out a vitrectomy on an eye, using a dye (indocyanine green specifically) on the back of the eye, then using a laser to create small holes on the eye (commonly called photoporation, “photo” means “light”, and “poration” means “forming pores”), thereafter the eye is treated with a therapeutic agent. Example 1, shown on pages 9-10, discloses a version of the process in detail.); and
- administering the therapeutic agent to the vitreous chamber of the eye of the subject (page 4, lines 26-32 discloses “The methods described herein also can be used to treat diseases of the inner retina (such as vascular occlusions and diabetic retinopathy), diseases of the optic nerve (such as optic neuropathies and glaucoma), diseases of the anterior portion of the eye (such as corneal endothelial deficiency, cataract, ocular hypertension, and glaucoma), inflammatory diseases of the eye (such as uveitis, ocular trauma, and ocular infections), and neoplastic diseases of the eye (such as choroidal tumors, epithelial tumors, and metastatic disease).”);
or the method comprising:
- administering the dye and the therapeutic agent to the vitreous chamber of an eye of the subject; and
- irradiating at least part of the ILM of the eye of the subject, thereby photoporating at least part of the ILM.
In reference to dependent claim 5, Comander discloses the method according to claim 3, wherein the dye is a vital dye (col 7, lines 26-29 disclose “It would be appreciated by a skilled artisan that that the ILM can be visualized using an ILM-visualization agent. Visualizing the ILM can allow for improved focus on the targeted region without unnecessary damage to the remaining retina or non-targeted regions. Visualization agents include, for example, indocyanine green dye (ICG)” ICG is a vital dye).
In reference to dependent claim 6, Comander discloses the method according to claim 3, wherein the dye is a vital dye selected from the group consisting of: Indocyanine Green (ICG) (col 7, lines 26-29 disclose “It would be appreciated by a skilled artisan that that the ILM can be visualized using an ILM-visualization agent. Visualizing the ILM can allow for improved focus on the targeted region without unnecessary damage to the remaining retina or non-targeted regions. Visualization agents include, for example, indocyanine green dye (ICG)”), Trypan Blue (TB), Brilliant Blue (BB), Janus green B (JG), Gentian violet (GV), Bromophenol Blue (BPB), Patent blue (PB), Light Green (LG), Fast Green (FG), Infracyanine Green (IfCG), Methylene blue (MB), Toluidine blue (ToB), Fluorescein Sodium (FS), Rose Bengal (RB), and Rhodamine 6G (R6G); preferably wherein the dye is ICG.
In reference to dependent claim 8, Comander discloses the method according to claim 3, wherein the dye is a free dye, an aggregate of the dye, or a crystal of the dye (page 6, line 5 specifically discloses “triamcinolone crystals”); wherein the dye is conjugated to a further agent; wherein the dye is comprised in a nanoparticle; and/or wherein the dye and the therapeutic agent are comprised in a nanoparticle.
In reference to dependent claim 9, Comander discloses the method according to claim 3, wherein the therapeutic agent is a retinal disease drug or a choroidal disease drug (page 4, lines 26-32 discloses “The methods described herein also can be used to treat diseases of the inner retina (such as vascular occlusions and diabetic retinopathy), diseases of the optic nerve (such as optic neuropathies and glaucoma), diseases of the anterior portion of the eye (such as corneal endothelial deficiency, cataract, ocular hypertension, and glaucoma), inflammatory diseases of the eye (such as uveitis, ocular trauma, and ocular infections), and neoplastic diseases of the eye (such as choroidal tumors, epithelial tumors, and metastatic disease).” Examiner takes the position that this would indicate a drug to treat the retina. Furthermore, page 4 lines 14-15 discloses “Methods are described herein that allow for highly efficient delivery of various agents, e.g., compounds, to the retina or another structure in the eye.”).
In reference to dependent claim 10, Comander discloses the method according to claim 3, wherein the therapeutic agent is selected from the group consisting of a stem cell, a protein (page 8, lines 5-6 discloses “Agents that can be delivered to the eye include, without limitation, proteins, antibodies, cells, small molecules, nanoparticles”), a polypeptide, a peptide, an antibody, an antibody fragment, an antibody-like protein scaffold, an aptamer, a photoaptamer, a spiegelmer, a peptidomimetic, a gene-editing system, a nucleic acid, and combinations thereof.
In reference to dependent claim 11, Comander discloses the method according to claim 3, wherein the therapeutic agent is comprised in a viral vector or in a nanoparticle (page 8, lines 5-6 discloses “Agents that can be delivered to the eye include, without limitation, proteins, antibodies, cells, small molecules, nanoparticles”).
In reference to dependent claim 12, Comander discloses the method according to claim 3, wherein the dye and/or the therapeutic agent is administered to the vitreous body by intravitreal injection (page 1, lines 17-18 discloses “For these reasons, there has been increased interest in intravitreal injection for retinal therapies.”).
In reference to dependent claim 13, Comander discloses the method according to claim 3, wherein the dye and/or the therapeutic agent is administered by injection into the vitreous chamber after removal of the vitreous body (page 10, lines 14-23 discloses “After the vitrectomy, indocyanine green (ICG) was injected onto the macula to stain and visualize the internal limiting membrane (ILM). The remaining ICG was washed out and ILM forceps were used to peel the ILM using the pinch-peel technique. See FIG. 1C. A circular area was peeled, centered on the fovea and extending mid- way to the vascular arcades. A soft-tipped cannula (Alcon) and a wide-field vitrectomy lens (DORC) were used to perform a fluid-air exchange. Under air, 150 μΐ of concentrated virus were dripped onto the fovea to form a "puddle" in the peeled area. See FIG. ID. The subject was allowed to remain in a supine position for 30 minutes before general anesthesia was reversed. Sub-conjunctival cefazolin and dexamethasone were administered.”).
In reference to dependent claim 14, Comander discloses the method according to claim 3, wherein the at least part of the ILM is irradiated with electromagnetic radiation; preferably wherein the at least part of the ILM is irradiated with laser radiation (page 7, lines 20-25 disclose “The ILM can be removed using any number of known techniques and mechanisms. For example, the ILM can be surgically removed by "peeling" or "stripping" it from the retina, e.g., using forceps or other tools (e.g., 25 gauge ILM forceps, pick, scraper) or using hydro-dissection. In addition, portions of the ILM can be removed by puncturing the ILM, cutting the ILM with, for example, a laser, enzymatically digesting the ILM, or any combination thereof.”); more preferably wherein the at least part of the ILM is irradiated with pulsed-laser radiation.
In reference to dependent claim 15, Comander discloses the method according to claim 3, wherein the retinal disease or the choroidal disease is selected from the group consisting of inherited retinal dystrophies, acquired diseases of the retina or choroid, inflammatory diseases of the retina or choroid (page 4, lines 26-32 discloses “The methods described herein also can be used to treat diseases of the inner retina (such as vascular occlusions and diabetic retinopathy), diseases of the optic nerve (such as optic neuropathies and glaucoma), diseases of the anterior portion of the eye (such as corneal endothelial deficiency, cataract, ocular hypertension, and glaucoma), inflammatory diseases of the eye (such as uveitis, ocular trauma, and ocular infections), and neoplastic diseases of the eye (such as choroidal tumors, epithelial tumors, and metastatic disease).”), vascular diseases of the retina or choroid, neoplastic diseases of the retina or choroid, ocular traumas, retinal tractional defects, and toxic retinopathy.
In reference to dependent claim 16, Comander discloses the method according to claim 3, wherein the retinal disease is selected from the group consisting of macular degeneration, diabetic retinopathy, retinitis pigmentosa, glaucoma, retinoblastoma, and inherited retinal dystrophies (page 4, line 26-30 discloses “The methods described herein also can be used to treat diseases of the inner retina (such as vascular occlusions and diabetic retinopathy), diseases of the optic nerve (such as optic neuropathies and glaucoma), diseases of the anterior portion of the eye (such as corneal endothelial deficiency, cataract, ocular hypertension, and glaucoma)”).
In reference to dependent claim 17, Comander discloses the method according to claim 3, , wherein the choroidal disease is selected from the group consisting of central serous chorioretinopathy, polypoidal choroidal vasculopathy, choroidal melanoma (page 4, lines 26-32 discloses “The methods described herein also can be used to treat diseases of the inner retina (such as vascular occlusions and diabetic retinopathy), -- and neoplastic diseases of the eye (such as choroidal tumors, epithelial tumors, and metastatic disease” melanoma is a form of tumors), choroidal neovascularization, choroideremia, and choroidal dystrophies.
In reference to dependent claim 19, Comander discloses the method according to claim 1, wherein one or more of:
- the dye is a vital dye;
- the dye is a vital dye selected from the group consisting of: Indocyanine Green (ICG) (col 7, lines 26-29 disclose “It would be appreciated by a skilled artisan that that the ILM can be visualized using an ILM-visualization agent. Visualizing the ILM can allow for improved focus on the targeted region without unnecessary damage to the remaining retina or non-targeted regions. Visualization agents include, for example, indocyanine green dye (ICG)”), Trypan Blue (TB), Brilliant Blue (BB), Janus green B (JG), Gentian violet (GV), Bromophenol Blue (BPB), Patent blue (PB), Light Green (LG), Fast Green (FG), Infracyanine Green (IfCG), Methylene blue (MB), Toluidine blue (ToB), Fluorescein Sodium (FS), Rose Bengal (RB), and Rhodamine 6G (R6G); preferably wherein the dye is ICG;
- the dye is administered at a concentration of about 0.001 mg/ml to about 0.5 mg/ml;
- the dye is a free dye, an aggregate of the dye, or a crystal of the dye;
- the dye is conjugated to a further agent; the dye is comprised in a nanoparticle; and/or the dye and the therapeutic agent are comprised in a nanoparticle;
- the therapeutic agent is a retinal disease drug (page 4, lines 26-32 discloses “The methods described herein also can be used to treat diseases of the inner retina (such as vascular occlusions and diabetic retinopathy), diseases of the optic nerve (such as optic neuropathies and glaucoma), diseases of the anterior portion of the eye (such as corneal endothelial deficiency, cataract, ocular hypertension, and glaucoma), inflammatory diseases of the eye (such as uveitis, ocular trauma, and ocular infections), and neoplastic diseases of the eye (such as choroidal tumors, epithelial tumors, and metastatic disease).” Examiner takes the position that this would indicate a drug to treat the retina.) or a choroidal disease drug;
- the therapeutic agent is selected from the group consisting of a stem cell, a protein, a polypeptide, a peptide, an antibody, an antibody fragment, an antibody-like protein scaffold, an aptamer, a photoaptamer, a spiegelmer, a peptidomimetic, a gene-editing system, a nucleic acid, and combinations thereof,
- the therapeutic agent is comprised in a viral vector or in a nanoparticle;
- the dye and/or the therapeutic agent is administered to the vitreous body by intravitreal injection;
- the dye and/or the therapeutic agent is administered by injection into the vitreous chamber after removal of the vitreous body; and/or
- the at least part of the ILM is irradiated with electromagnetic radiation; preferably wherein the at least part of the ILM is irradiated with laser radiation; more preferably wherein the at least part of the ILM is irradiated with pulsed-laser radiation.
In reference to dependent claim 23, Comander discloses the method according to claim 22, wherein one or more of:
- the dye is a vital dye;
- the dye is a vital dye selected from the group consisting of: Indocyanine Green (ICG) (col 7, lines 26-29 disclose “It would be appreciated by a skilled artisan that that the ILM can be visualized using an ILM-visualization agent. Visualizing the ILM can allow for improved focus on the targeted region without unnecessary damage to the remaining retina or non-targeted regions. Visualization agents include, for example, indocyanine green dye (ICG)”), Trypan Blue (TB), Brilliant Blue (BB), Janus green B (JG), Gentian violet (GV), Bromophenol Blue (BPB), Patent blue (PB), Light Green (LG), Fast Green (FG), Infracyanine Green (IfCG), Methylene blue (MB), Toluidine blue (ToB), Fluorescein Sodium (FS), Rose Bengal (RB), and Rhodamine 6G (R6G); preferably wherein the dye is ICG;
- the dye is administered at a concentration of about 0.001 mg/ml to about 0.5 mg/ml;
- the dye is a free dye, an aggregate of the dye, or a crystal of the dye; - the dye is conjugated to a further agent; the dye is comprised in a nanoparticle; and/or the dye and the therapeutic agent are comprised in a nanoparticle;
- the therapeutic agent is a retinal disease drug (page 4, lines 26-32 discloses “The methods described herein also can be used to treat diseases of the inner retina (such as vascular occlusions and diabetic retinopathy), diseases of the optic nerve (such as optic neuropathies and glaucoma), diseases of the anterior portion of the eye (such as corneal endothelial deficiency, cataract, ocular hypertension, and glaucoma), inflammatory diseases of the eye (such as uveitis, ocular trauma, and ocular infections), and neoplastic diseases of the eye (such as choroidal tumors, epithelial tumors, and metastatic disease).” Examiner takes the position that this would indicate a drug to treat the retina) or a choroidal disease drug;
- the therapeutic agent is selected from the group consisting of a stem cell, a protein, a polypeptide, a peptide, an antibody, an antibody fragment, an antibody-like protein scaffold, an aptamer, a photoaptamer, a spiegelmer, a peptidomimetic, a gene-editing system, a nucleic acid, and combinations thereof,- the therapeutic agent is comprised in a viral vector or in a nanoparticle;
- the dye and/or the therapeutic agent is administered to the vitreous body by intravitreal injection;
- the dye and/or the therapeutic agent is administered by injection into the vitreous chamber after removal of the vitreous body;
- the at least part of the ILM is irradiated with electromagnetic radiation; preferably wherein the at least part of the ILM is irradiated with laser radiation; more preferably wherein the at least part of the ILM is irradiated with pulsed-laser radiation;
- the retinal disease or the choroidal disease is selected from the group consisting of inherited retinal dystrophies, acquired diseases of the retina or choroid, inflammatory diseases of the retina or choroid, vascular diseases of the retina or choroid, neoplastic diseases of the retina or choroid, ocular traumas, retinal tractional defects; and toxic retinopathy;
- the retinal disease is selected from the group consisting of macular degeneration, diabetic retinopathy, retinitis pigmentosa, glaucoma, retinoblastoma, and inherited retinal dystrophies; and/or
- the choroidal disease is selected from the group consisting of central serous chorioretinopathy, polypoidal choroidal vasculopathy, choroidal melanoma, choroidal neovascularization, choroideremia, and choroidal dystrophies.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Comander (WO2016/179496) in view of Ambrosone (WO 2018/011705).
In reference to dependent claim 7, Comander discloses the method according to claim 3, however
Comander is silent to the dye is administered at a concentration of about 0.001 mg/ml to about 0.5 mg/ml.
Ambrosone, a similar ophthalmic method, teaches the dye is administered at a concentration of about 0.001 mg/ml to about 0.5 mg/ml (page 5, lines 29-3 discloses “The vital dye used for the invention is one of those normally used in ophthalmology and is selected for example from: indocyanine green, infracyanine green, sodium fluorescein, trypan blue, Patent blue, bromophenol blue, brilliant blue G. The amount of dye depends on the type used; for indocyanine green, the concentration preferably used is between 0.125 μg (micrograms) to 25 mg (milligrams) per imL”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the dye concentrations of Ambrosone in the method of Comander for “using the [[above]] dyes in a safe manner” page 4, line 6; Ambrosone.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Herekar (USPAP 2016/0113816) discloses a system that uses photoporation.
Herekar (USPAP 2018/0207029) discloses a system that uses photoporation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.W.N/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783