The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-16, are pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-14, 16, 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.
Preventing, claim 1, implies a disease has not occurred. However, the specification fails to disclose how a “normal” subject who may develop each disorder can be identified and treated to avoid the occurrence of each disorder. Deleting “preventing or” will overcome the rejection.
Claims 10-11, invite a POSA to identify applicable small molecules, proteins, peptides nucleic acids, and make them using any means/procedure known to the artisan. There is no incorporation by reference of US publications where the enablements can be found. Deleting the claims will obviate the rejection.
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 filed 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 1-16, are rejected under pre-AIA 35 U.S.C.103(a) as being unpatentable over Feng et al., WO2012/118796; in view of Chua et al., J. Cell Commun. Signal (2015), 9:167-76; Alekseev et al., ARVO Annual Meeting Abstract (2011), 52:6703, 2 pages; Klein et al, US2009/0076091, Richardson et al., WO2019/048852; Jobson et al., J. Pharm & Env Therapeutics (2009) 331:816-826; Caldwell et al., J. Med. Chem. (2011), 54:580-590; Zabludoff et al., Mol. Cancer Ther (2008), 7(9):2955-66; Arienti et al., J. Med. Chem. (2005), 48:1873-85; AmBeed, A branch of Bephaem Sci, Catalog.
Feng et al., teaches IGFBPL1, is a key factor in promoting axon outgrowth in retinal ganglion cells (RCC). It reverses the developmental loss of axon, reduces optic nerve degeneration, increases optical nerve growth or regeneration. The composition is useful for treating glaucoma, optic neuritis, optic neuropathy, retinal neuron damage due to macular degeneration, age related macular degeneration or physical injuries. It is useful for treating axon degeneration in the peripheral and CNS, such as traumatic brain injury, or spinal cord injury. The composition is useful for treating MS, Alzheimer’s disease, Parkinson’s disease, ALS, Huntington’s disease or any form of neurological injury or disease resulting from any source including exposure to a toxin. See the entire document, particularly the title and Summary of the invention.
Chua et al., teaches IGFBPs (IGFBPLs) 1 to 6, are involved in detecting and repairing double-stranded breaks (DSB). See the entire document, particularly pp. 167-69.
Alekseev et al., teaches small molecule inhibitors, such as Chk2 inhibitors, were used to inhibit host DNA damage response. The inhibitors suppressed infectious particle production, genome replication, and transcriptional activity of herpes simplex virus in human corneal epithelial cells. The prior art teaches the inhibitors are novel therapies for HP keratitis. See the abstract.
Klein et al, teaches Chk2 inhibitors and compositions thereof, are useful “for the treatment of diseases or conditions in which inhibition of ChK1 and/or ChK2 activity is advantageous”, such as, glaucoma or cataract, neuropathy, Alzheimer’s disease, etc. [0009], [0014], [0016]. The prior art teaches the inhibitors can be used in combination therapy, [0053]. See also the entire document, particularly claims 5-6, 11-12.
Richardson et al., teaches Chk2 inhibitors and compositions thereof, are useful for preventing or treating a neurodegenerative disease, or any disease relating to inhibition of Chk2, e.g. in CNS, brain peripheral nerves or inflammation. The inhibitor may be administered with another inhibitor. See the entire document, particularly pp. 3-5.
Jobson et al., teaches PV1019 is a Chk2 inhibitor. See the entire document, particularly the title and the abstract. Therefore, a POSA would have known and be motivated to try PV1019 for treating eye conditions at the time the invention was made with reasonable expectation of success.
Caldwell et al., teaches CCT241533 is a Chk2 inhibitor. See the entire document, particularly the title and the abstract. Therefore, a POSA would have known and be motivated to try CCT241533 for treating eye conditions at the time the invention was made with reasonable expectation of success.
Zabludoff et al., teaches AZD7762 is a Chk2 inhibitor. See the entire document, particularly the title and the abstract. Therefore, a POSA would have known and be motivated to try AZD7762 for treating eye conditions at the time the invention was made with reasonable expectation of success.
Arienti et al., teaches BML277 is a Chk2 inhibitor. See the entire document, particularly the title and the abstract. Therefore, a POSA would have known and be motivated to try BML277 for treating eye conditions at the time the invention was made with reasonable expectation of success.
AmBeed, teaches prexasertib is a Chk2 inhibitor, commercially available. AmBeed, https://www.ambeed.com/products/prexasertib.html,visited 5/28/25. Therefore, a POSA would have known and be motivated to try prexasertib for treating eye conditions at the time the invention was made with reasonable expectation of success.
Having known that Chk2 inhibitors are useful for treating glaucoma, cataract, etc. a POSA would have known and be motivated to try Chk2 inhibitors, e.g. those set forth above, for the treatment of eye conditions at the time the invention was made, with reasonable expectation of success.
The invention is not allowable over the combination of the prior arts and knowledge well-known in the art.
Objection
The specification is objected to for having no paragraph numbers.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Taofiq A. Solola, whose telephone number is (571) 272-0709.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor Andy Kosar, can be reached on (571) 272-0913. The fax phone number for this Group is (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the Group receptionist whose telephone number is (571) 272-1600.
/TAOFIQ A SOLOLA/Primary Examiner, Art Unit 1625
August 29, 2025