DETAILED ACTION
Election/Restrictions
Applicant’s election with traverse of the condition to be retinopathy of prematurity, the ETS inhibitor to be the compound YK 4-279, the mode of administration to be intravitreal ocular implant, and the composition form to be a gel in the reply filed on 12/18/2025 is acknowledged. The restriction is traversed on the grounds for meeting burden. This is not found persuasive because the instant case is submitted under 35 U.S.C. 371, the Unity of Invention practice in MPEP §1850 and MPEP §1893.03(d) was followed, not restriction practice. Thus the criteria for burden stated in MPEP §803 for national applications filed under 35 U.S.C. 111(a) does not apply (MPEP §801). The lack of unity has been addressed in the previous action. As the technical feature did not contribute over the art, the restriction was applied appropriately.
The requirement is still deemed proper and is therefore made FINAL.
Upon review, the condition is expanded to include leukemic retinopathy and diabetic retinopathy, and the inhibitor is expanded to include TK216 and
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The species requirement with regards to the composition form and the mode of administration is withdrawn.
Status of Application
Applicant has elected the condition to be retinopathy of prematurity, the ETS inhibitor to be the compound YK 4-279, the mode of administration to be intravitreal ocular implant, and the composition form to be a gel in the reply in response to restriction/species requirement and for the examination.
Claims 1-3, 7-13, 17-24 are pending.
Claims 1-3, 7-13, 17-24 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement filed 03/16/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7 and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to the method of inducing vascular regression in poorly perfused blood vessels in a subject comprising providing the subject with an effective amount of an inhibitor of an Endothelial ETS Family Transcription Factor, and then further comprising measuring vascular regression in poorly perfused blood vessels by hyaloid regression.
However, the instant specification does not describe what means or how to measure vascular regression by hyaloid regression in a subject/patient.
The specification for the hyaloid regression measurement of the vascular regression in poorly perfused blood vessels is done in 3-dimensional culture of human umbilical vein endothelial cells (HUVECs) which is a culture model and not in a subject with the condition that is administered the ETS inhibitor wherein the specification does not adequately describe the means or testing done for one to measure the vascular regression by hyaloid regression in a subject with the condition, there is only a description for a 3D culture model. It is also does not describe or disclose how the step is performed as hyaloid regression is generally during fetal development and early eye formation - which is not during child and adult ages wherein there is no written description provided to demonstrate how to do this measurement in a subject with the condition in conjunction with the administration of the ETS inhibitor.
Claims 10 and 20, 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the claimed invention. The term “wherein the inhibitor of an Endothelial ETS Family Transcription Factor does not inhibit vascular endothelial growth factor” is not adequately described as it is defined by a functional characteristic where it is defined by what it does and not what it is. Second, it does not describe adequately the degree of access, binding, or activity to the receptor to ascertain what compounds would fulfill the description. As a result, the fact pattern indicates that the artisan was not in possession of the claimed method of use.
Further, if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the compound, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. There is insufficient disclosure of a “representative number” of species for one of skill in the art to recognize that the applicant was in possession of the necessary common attributes or feature of the genus in view of the single specific formula disclosed in the specification.
The specification has only provided one single specific formula of
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for the broad and generic breath claimed. Additionally, the core of the disclosed compound does not adequately describe the relationship between a structure with the function ETS inhibitor and function to a different set of receptors of VEGF. Thereby, while having written description for
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, the specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims.
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 3, 13 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 recite that the inhibitor
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The claims are unclear as it recites YK 4-279, TK216, or derivatives have the formula respectively
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but it is unclear which formula the derivatives are directed to. It is also unclear as
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is YK4-279, and
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is TK216 wherein the phrase is confusing as it is a duplicate of the of the same active.
For purposes of examination, the phrase is treated as YK 4-279
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, TK216
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, or derivatives of YK 4-279 and TK216 that have the formula
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The formula of
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is also indefinite as it recites that the
formula
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wherein the recitation that R1, R2, R3 can be a substituted or unsubstituted aryl group, and R’ and R” can be a substituted or unsubstituted aryl group; is indefinite as it is unclear what the substituents are for the aryl group. It does not allow one of ordinary sill in the art to ascertain the metes and bounds of the claims.
Claim 8 is 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 8 recites the limitation "wherein the composition is an eye drop, gel, ointment, spray, a reservoir, or mist" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 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 18 recites the limitation "wherein the composition is an eye drop, gel, ointment, spray, a reservoir, or mist" in claim 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 is 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 claim recites that the inhibitor
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or
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; wherein the claim is unclear which formula the derivatives are directed to. It is also unclear as
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is YK 4-279, and
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is TK216 wherein the phrase is confusing as it is a duplicate of the of the same active.
It does not allow one to ascertain the metes and bounds of the claim as written.
Claim 23 is 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 23 recites the limitation "wherein the molecule has the formula” in claim 21. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 is 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 claim recite that “the molecule has the formula:
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which is indefinite as the recitation that R1, R2, R3 can be a substituted or unsubstituted aryl group, and R’ and R” can be a substituted or unsubstituted aryl group; as it is unclear what the substituents are for the aryl group. It does not allow one of ordinary sill in the art to ascertain the metes and bounds of the claims.
Claim 24 is 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 24 recites the limitation "wherein the composition is an eye drop, gel, ointment, spray, a reservoir, or mist" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 is 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 claim recites in the method for a subject of claim 1 for further comprising measuring vascular regression in poorly perfused blood vessels by hyaloid regression, which is indefinite as it is unclear how one can measure vascular regression by hyaloid regression as hyaloid regression is during fetal development and early eye formation - which is not during child and adult ages. It is also unclear as review of the specification for the hyaloid regression measurement of the vascular regression in poorly perfused blood vessels appears to be done in 3-dimensional culture of human umbilical vein endothelial cells (HUVECs) which is a culture model and not in a subject with the condition that is administered the ETS inhibitor wherein it is unclear what the metes and bounds are for the claim as written. It is also unclear how the claimed step is performed as there is no written description provided to demonstrate how to do this measurement in a subject with the condition upon administration of the ETS inhibitor. The claim cannot be further treated on its merits.
Claim 17 is 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 claim recites in the method for a subject of claim 11 for further comprising measuring vascular regression in poorly perfused blood vessels by hyaloid regression, which is indefinite as it is unclear how one can measure vascular regression by hyaloid regression as hyaloid regression is during fetal development and early eye formation - which is not during child and adult ages. It is also unclear as review of the specification for the hyaloid regression measurement of the vascular regression in poorly perfused blood vessels appears to be done in 3-dimensional culture of human umbilical vein endothelial cells (HUVECs) which is a culture model and not in a subject with the condition that is administered the ETS inhibitor wherein it is unclear what the metes and bounds are for the claim as written. It is also unclear how the claimed step is performed as there is no written description provided to demonstrate how to do this measurement in a subject with the condition upon administration of the ETS inhibitor. The claim cannot be further treated on its merits.
Claims 9 and 19 and 24 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 recites “wherein the inhibitor of an Endothelial ETS Family Transcription Factor at least one of: decrease retinal neovessels or vascular malformations by at least 40% or a retinal avascular area by at least 60% compared to a vehicle-injected contralateral eye” or “wherein the inhibitor at least one of: decrease retinal neovessels or vascular malformations by at least 40% or a retinal avascular area by at least 60% compared to a vehicle-injected contralateral eye” which is indefinite as it is unclear what is meant by phrase wherein the ETS inhibitor “at least one of: decrease retinal neovessels or vascular malformations by at least 40% or a retinal avascular area by at least 60% compared to a vehicle-injected contralateral eye”. What is the inhibitor of an Endothelial ETS Family Transcription Factor at least one of? Especially how does the decrease of retinal neovessels or vascular malformation by at least 40% relate to the ETS inhibitor? Also what is a retinal neovessel? The vascular malformations are not recited to be in the eye so how is it related to the retinal avascular area by at least 60% compared to a vehicle injection contralateral eye? It does not allow one to ascertain the metes and bounds of the claims as written. For purposes of examination, it is treated as wherein the inhibitor of an endothelial ETS family transcription factor is capable to decrease retinal vessel or vascular malformations.
Claim 21 is 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 recites “wherein there is a decrease retinal neovessels or vascular malformations, a decrease in a retinal avascular area, or both a vehicle-injected contralateral eye” which is indefinite as it is unclear what is meant by phrase “both a vehicle-injected contralateral eye” or “retinal neovessel”. What is a retinal neovessel? A decrease in what in the retinal avascular area ? What is “both a vehicle-injected eye”? It does not allow one to ascertain the metes and bounds of the claims as written. For purposes of examination, it is treated wherein there is a decrease retinal vessels or vascular malformations.
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 1-2, 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oettgen et al. (WO 02/055698).
The claims as written are so broad as to read on the following prior art.
Rejection:
Oettgen et al. teaches modulating the development of blood vessels and/or endothelial cell differentiation in a mammal comprising altering the activity of an ETS transcription factor comprising administering a compound/substance. The transcription factor comprises ELF-1 (within the Endothelial ETS Family Transcription Factor) and can decrease blood vessel development and angiogenesis.
Oettgen et al. teaches and claims methods of treating diseases including diabetic retinopathy with decreasing angiogenesis (decrease VEGF) and decreasing blood vessel development which can be provided locally with the substance such as DNA viruses and other compounds (claims 20, 51, 53-55; , page 2 line 5-8, Page 3 line 11-17 and 25-Page 4 line 2, Page 4 line 25-36, Page 5 line 15-26, Page 6 line 32-Page 7 line 4, Page 9 line 10-17). The formulations would have an appropriate carrier in accordance with the mode of administration routinely performed in the art like topical administration (Page 30 line 15-20, Page 31 line 34-35, see full document specifically areas cited). The active would have the same level of regression of the areas (retinal neovessels or vascular malformation) and lack of VEGF inhibition as it inherently is present with the ELF-1/ETS inhibitor and Oettgen et al. establishes that it reduces blood vessel development and angiogenesis and treats diabetic retinopathy wherein when administered to the patient - as an active and its properties cannot be separated.
All the critical elements are taught by the cited reference and thus the claims are anticipated.
Claims 1, 3, 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lannutti et al. (WO 2018/022771).
Rejection:
Lannutti et al. teaches and claims treating acute myeloid leukemia with the administration of at least one therapeutic agent including a compound of formula I and claims the compounds
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(YK 4-279, claims 1-2, 18-20, 24); wherein the administration of the compounds for treatment would inherently treat any poorly perfused blook vessels or vascular malformation present as the instant claims do not delineate the patient population (“a patient in need thereof”) and would have the same level of regression of the areas (retinal neovessels or vascular malformation) and lack of VEGF inhibition as it inherently is present as the same active is administered to the patient as an active and its properties cannot be separated.
All the critical elements are taught by the cited reference and thus the claims are anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 11-12, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Oettgen et al. (WO 02/055698) as applied to claims 1-2, 9-10 above.
Rejection:
The teachings of Oettgen et al. are addressed above.
While Oettgen et al. does not expressly recite the step of identifying the patient it is implicit if not prima facie obvious that the patient would have been identified to have diabetic retinopathy prior to being treated. The active would have the same level of regression of the areas (retinal neovessels or vascular malformation) and lack of VEGF inhibition as it is present with the ELF-1/ETS inhibitor and Oettgen et al. establishes that it reduces blood vessel development and angiogenesis and treats diabetic retinopathy wherein when administered to the patient - as an active and its properties cannot be separated.
Claims 8,18, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Oettgen et al. (WO 02/055698) as applied to claims 11-12, 19-20 above, in view of Winfield (Ophthalmic Products-Introduction, Formulation of eye drops).
Rejection:
The teachings of Oettgen et al. are addressed above.
Oettgen et al. does not expressly teach the mode of administration and form but does teach treating diabetic retinopathy with the inhibitor and that the formulations would have an appropriate carrier in accordance with the mode of administration routinely performed in the art like topical administration.
Winfield teaches that known forms for ophthalmic products include eyedrops for instillation (topical administration).
Wherein it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat diabetic retinopathy by known means like topical instillation with an eyedrop as suggested by Winfield and produce the claimed invention; as it is prima facie obvious to utilize the known means and forms for ophthalmic treatment with a reasonable expectation of success. The active would have the same level of regression of the areas (retinal neovessels or vascular malformation) and lack of VEGF inhibition that is present with the ELF-1/ETS inhibitor, and Oettgen et al. establishes that it reduces blood vessel development and angiogenesis and treats diabetic retinopathy wherein the properties and mechanism of action of the compound cannot be separated and would be expected to block the interaction between the ETS factor and Kruppel-like fact protein as it naturally flows from performing the administration of the inhibitor in the disclosed means of administration.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Oettgen et al. (WO 02/055698) as applied to claims 11-12, 19-20 above, in view of de Barros Garcia et al. (Diabetic retinopathy and OCT angiography: clinical findings and future perspectives -Abstract only).
Rejection:
The teachings of Oettgen et al. are addressed above.
Oettgen et al. does not expressly teach doing a vascular regression analysis of the poorly perfused blood vessel, but does teach treating diabetic retinopathy.
de Barros Garcia et al. teaches that it is known to assess retinal st4ucture and evaluate the retinal microvasculature and identify the disorders including diabetic retinopathy with optical coherence tomography (an analysis of the vascular regression of the poorly perfused blood vessel).
Wherein it would have been implicit if not obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize optical coherence tomography to identify the eye condition having neovascularization (poorly perfused blood vessel) prior to treatment as suggested by de Barros Garcia et al. and produce the claimed invention; as it is implicit if not prima facie obvious to identify the condition in the patient with known means and documentation like optical coherence tomography prior to treating it with a reasonable expectation of success.
Claims 1-2, 11-13, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lannutti et al. (WO 2018/022771) as applied to claims 1, 3, 9-10 above, in view of Rosenthal (Ocular Manifestations of Leukemia: A Review).
Rejection:
The teachings of Lannutti et al. are addressed above including treating conditions like acute myeloid leukemia with compounds like TK216 and YK 4-279. Lannutti et al. also teaches that the ETS family of transcription factor are criticality for proliferation and sustained angiogenesis and these inhibitory compounds like TK216 and YK 4-279 have anti-proliferative effects [11, 96, 98-100,104, 109, 119, 123].
Lannutti et al. does not expressly teach treating the recited conditions like certain vascular malformations and diabetic retinopathy, but does teach treating conditions like acute myeloid leukemia with compounds like TK216 and YK 4-279.
Rosenthal teaches that leukemic retinopathy and orbital infiltration is commonly observed in patients with acute and chronic leukemia. The leukemic retinopathy may be the only manifestation of the recurrence of the leukemic process in rare instances.
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat leukemic retinopathy (a vascular malformation) as suggested by Rosenthal and produce the claimed invention; as Lannutti et al. teaches treating acute myeloid leukemia with compounds like TK216 and YK 4-279 and it is prima facie obvious to treat not only the source condition (i.e. acute myeloid leukemia) with the compounds but also its symptoms like leukemic retinopathy with a reasonable expectation of success. It is also implicit if not prima facie obvious to have identified the patient to have the condition to treat it. The effects and properties of the inhibitor used for the treatment like the lack of VEGF inhibition and the amount of reduction of the vascular/vessel area would be expected to be the same as it naturally flows from performing the administration of the inhibitor in the disclosed means of administration.
Claims 8, 18, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Lannutti et al. (WO 2018/022771) in view of Rosenthal (Ocular Manifestations of Leukemia: A Review) as applied to claims 1-2, 11-13, 19-20 above, further in view of Winfield (Ophthalmic products-Introduction, Formulation of eye drops).
Rejection:
The teachings of Lannutti et al. in view of Rosenthal are addressed above. Lannutti et al. in view of Rosenthal does not expressly teach the mode of administration and form for treating an ocular conditions like leukemic retinopathy.
Winfield teaches that known forms for ophthalmic products include eyedrops for instillation (topical administration).
Wherein it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat leukemic retinopathy by known means like topical instillation with an eyedrop as suggested by Winfield and produce the claimed invention; as it is prima facie obvious to utilize the known means and forms for ophthalmic treatment with a reasonable expectation of success. The compound inhibitor is the same compound as disclosed in the instant specification and claims wherein the properties and mechanism of action of the compound cannot be separated and would be expected to block the interaction between the ETS factor and Kruppel-like fact protein as it is the same compounds disclosed in the instant specification and dependent claims. The effects and properties of the inhibitor used for the treatment like the lack of VEGF inhibition and the amount of reduction of the vascular/vessel area would be expected to be the same as it naturally flows from performing the administration of the inhibitor in the disclosed means of administration.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Lannutti et al. (WO 2018/022771) in view of Rosenthal (Ocular Manifestations of Leukemia: A Review) as applied to claims 1-2, 11-13, 19-20 above, further in view of Le et al. (Optical coherence tomography findings of bilateral foveal leukemic infiltration-Abstract only).
Rejection:
The teachings of Lannutti et al. in view of Rosenthal are addressed above.
Lannutti et al. in view of Rosenthal does not expressly teach doing a vascular regression analysis of the poorly perfused blood vessel, but does teach treating leukemic retinopathy (a vascular malformation) with compounds like TK216 and YK 4-279 (ETS inhibitors).
Le et al. teaches that it is known to do a clinical examination to reveal bilateral foveal infiltration which was demonstrated on optical coherence tomography (an analysis of the vascular regression of the poorly perfused blood vessel) and re-evaluate the regression of the retinal lesions with treatment with serial optical coherence tomography and fundus photographs.
Wherein it would have been implicit if not obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize known documentation like optical coherence tomography prior to treatment and after treatment as suggested by Le et al. and produce the claimed invention; as it is implicit if not prima facie obvious to identify the condition in the patient with known means and documentation like optical coherence tomography prior to treating it and to use them after treatment to evaluate the amount of improvement/regression with a reasonable expectation of success.
Conclusion
Claims 1-3, 7-13, 17-24 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613