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 99 has been added.
Claims 1, 2, 17, 18, 23, 28, 29, 34, 98 and 99 are pending.
Claims 3-16, 19-22, 24-27, 30-33, and 35-97 are cancelled.
Claims 1 and 17 are amended.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/06/2026 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 17, 18, 23, 28, 29, 34 and 98-99 are rejected under 35 U.S.C. 103 as being unpatentable over EARLY (An automated high-resolution in vivo screen in zebrafish to identify chemical regulators of myelination. eLife. 2018.) in view of GONZALEZ-FERNANDEZ (Novel strategy for subretinal delivery in Xenopus. Molecular Vision. 2011).
Regarding claim 1, EARLY teaches a method of in vivo screening of compounds in zebrafish (abstract) that comprises: administering compounds to a zebrafish embryo (page 2, paragraph 3) via exposing the embryos to a target compound, diluted with water, in well plates (Page 8, paragraph 1), which reads on the first part of step A administering a candidate substance to an embryo of an animal (excluding human).
The embryos were examined for the amount of differentiated cells in the spinal cord before administration of an active compound (Page 5, paragraph 3), which reads on step C obtaining a measurement of an amount of differentiated cells of the specific tissue in the animal that has undergone step A.
The embryos were then administered SKP2-25 and examined again to determine the increase of differentiated cells (Page 5, paragraph 3 and page 6, paragraph 1), which reads on step D as the active ingredient, or a candidate substance that increases the amount of differentiated cells of the specific tissue measured in step C,
Note, the limitation in claim 1 of wherein the active ingredients are for the treatment or prevention of a disease, disorder, or illness of a nervous system, or symptoms thereof, caused by damage or functional decline of the nervous system is inherent since all active steps within the claim are met. Furthermore, EARLY teaches multiple active ingredients were examined including Apicidin, which is a HDAC inhibitor (table 2). Since HDAC inhibiters are defined in claim 34 as a candidate substance being screened, it would be inherent that the active ingredients are for the treatment or prevention of a disease, disorder, or illness of a nervous system, or symptoms thereof, caused by damage or functional decline of the nervous system is inherent since the same candidate substance is being screened in the prior art.
Regarding claim 17, zebrafish were examined (abstract).
Regarding claims 18 and 98, the purpose of the study was to examine cells that affect the nervous system and cause diseases and determine therapeutic treatments for such diseases (abstract).
Regarding claims 23 and 29, a fluorescent reporter was used to determine the amount of cells in specific areas (Page 3, paragraph 4 and page 5 paragraph 1) and the differentiated cells were measured using 2D maxima identification tool (Page 5, paragraph 2).
Regarding claim 34, multiple active ingredients were examined including Apicidin, which is a HDAC inhibitor (table 2).
Additional disclosure: CI-994 was screened using the method (Supplemental table 1).
EARLY does not teach the specific form of administration of the active ingredient, such as injecting into a specific site on the embryo, such as the optic vesicle.
Regarding claim 1, GONZALEZ-FERNANDEZ teaches a method of injecting an active agent specifically into the optic vesicle of embryos using a micromanipulator (abstract). This method was less invasive/traumatic to the embryos being studied (page 2957, paragraph 4) and allowed for the eye to specifically be studied as it forms after injection (page 2957, paragraph 5).
Regarding claim 99, GONZALEZ-FERNANDEZ teaches a method of injecting an active agent specifically into the optic vesicle of embryos using a micromanipulator (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate injecting into a specific site on the embryo, such as the optic vesicle. The person of ordinary skill in the art would have been motivated to make those modifications, because the method is less invasive/traumatic and allowed for the eye to be specifically studied after the local injection to the eye, and reasonably would have expected success because the references are in the same field of endeavor, such as administering an active agent to an embryo.
Claims 1, 2, 17, 18, 23, 28, 29, 34 and 98-99 are rejected under 35 U.S.C. 103 as being unpatentable over EARLY (An automated high-resolution in vivo screen in zebrafish to identify chemical regulators of myelination. eLife. 2018.) and GONZALEZ-FERNANDEZ (Novel strategy for subretinal delivery in Xenopus. Molecular Vision. 2011) in view of ZHANG (Class I histone deacetylase (HDAC) inhibitor CI-994 promotes functional recovery following spinal cord injury. Cell Death and Disease. 2018.).
EARLY and GONZALEZ-FERNANDEZ teach Applicant’s invention as discussed above.
EARLY and GONZALEZ-FERNANDEZ do not specifically teach that CI-994 is used as a treatment for spinal cord injuries.
Regarding claim 2, ZHANG teaches that HDAC inhibitors, such as CI-994 are used as treatment for spinal cord injuries (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate screening for an active ingredient for the treatment of a spinal cord injury. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success, because EARLY screens for CI-994 and CI-994 is a treatment for a spinal cord injury.
Response to Arguments
Applicant argues, the references do not teach a local injection into a region that develops into a specific tissue in the embryo of the animal as recited in claim 1.
Examiner does not find the argument persuasive because as discussed above, GONZALEZ-FERNANDEZ teaches a method of injecting an active agent specifically into the optic vesicle of embryos using a micromanipulator (abstract). This method was less invasive/traumatic to the embryos being studied (page 2957, paragraph 4) and allowed for the eye to specifically be studied as it forms after injection (page 2957, paragraph 5).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate injecting into a specific site on the embryo, such as the optic vesicle. The person of ordinary skill in the art would have been motivated to make those modifications, because the method is less invasive/traumatic and allowed for the eye to be specifically studied after the local injection to the eye, and reasonably would have expected success because the references are in the same field of endevo9ur, such as administering an active agent to an embryo.
The applicant argues, the experimental data provided in the attached Declaration of Hideki Ando shows a high hit rate for the candidate compounds is attributable to the local injection in developing tissue and is an unexpected result from local injection and measurement of the specific tissue.
In order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980).
In the instant case, GONZALEZ-FERNANDEZ teaches a method of injecting an active agent specifically into the optic vesicle of embryos using a micromanipulator (abstract). This method was less invasive/traumatic to the embryos being studied (page 2957, paragraph 4) and allowed for the eye to specifically be studied as it forms after injection within the eye (page 2957, paragraph 5).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate injecting into a specific site on the embryo, such as the optic vesicle. The person of ordinary skill in the art would have been motivated to make those modifications, because the method is less invasive/traumatic and allowed for the eye to be specifically studied after the local injection to the eye, and reasonably would have expected success because the references are in the same field of endevo9ur, such as administering an active agent to an embryo.
As described, the prior art also teaches local injection and using this local injection for further study of the specific site.
Conclusion
No claims are allowable.
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/S.L.M./ Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618