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 office action is in response to applicant’s reply filed on April 20, 2026.
Status of Claims
Amendment of claims 3 and cancellation of claims 9-12 is acknowledged
Claims 1-8 and 13-19 are currently pending and are the subject of this office action.
Claim 1-2 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 21, 2025.
Claims 3-8 and 13-19 are under examination
Priority
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Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 103 (Modified Rejection Necessitated by Amendment).
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.
Claim(s) 3, 7-8, and 13-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keirstead et. al. (US 7,285,415, cited in prior office action), Sanberg et. al. (US 2002/0028510, cited in prior office action), Weiss et. al. (US 2007/0009491, cited in prior office action), Bertilsson et. al. (US 2005/0009742, cited in prior office action) and Sanders et. al. (Neurology (April 2014) 82(10 Supplement) pages 1-6, cited in prior office action).
For claims 3, 7-8, and 13-19, Keirstead teaches a method for the efficient production of glial cells like oligodendrocytes in vitro comprising culturing cells in a medium comprising one or more differentiation factors like: a ligand for a thyroid hormone receptor like triiodothyronine (T3, a thyroid hormone) (see columns 3 and 4 under summary).
Sanberg, teaches a method for inducing differentiation of pluripotent stem and/or progenitor cells into neuronal and glial cells like oligodendrocytes in vitro (see [0026], [0028] and [0053]). The method includes culturing the cells in a medium comprising a differentiation agent such as: thyroid hormones like triiodothyronine (T3) and thyroxine (T4) (see [0038] and [0064]).
Weiss teaches that cells, when contacted with a thyroid hormone, T3 gives rise to a differentiated neuron, oligodendrocytes, astrocyte or mixtures thereof (see [0005]).
Bertilsson teaches that the thyroid hormone T3 promotes oligodendrocyte differentiation (see [0005])
None of the above references teaches culturing the cells in vitro with the RXR agonist IRX4204 or its salts. However, Sanders teaches that the compound IRX4204 is an RXR agonist that promotes differentiation of oligodendrocyte precursor cells (OPC, i.e. glial cells) into oligodendrocytes (i.e. glial cells) in vitro.
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IRX4204
Before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to grow glial cells like oligodendrocytes in vitro combining two compositions (the RXR agonist IRX4204 and the thyroid hormone T3 (triiodothyronine) or T4 (Thyroxine)) each of which is taught by the prior art to be useful for the same purpose (grow glial cells in vitro), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from there having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Sanders does not teach a salt of IRX4204. However, it is well known that pharmaceutically acceptable salts of known compounds retain the same or similar biological properties as the neutral compound.
The prior art is silent regarding: “wherein the resulting neurons or glial cells are for subsequent implantation in a subject’s nervous system, wherein the subject has a nervous system disorder or a neurological condition or disease”. However, the above statement is considered an intended use of a composition made obvious by the prior art: neurons or glial cells and does not add any new limitation to the claim. Catalina Mktg. Int’l, Inc. V. Coolsavings.com, Inc., 289 F.3d 801, 808, 62 USPQ2d 1781, 1785 (fed. Cir. 2002). “The recitation of a new intended use for an old product does not make a claim to that old product patentable.” In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997).
Similar argument is made for claims 16-19
All this will result in the practice of claims 3, 7-8 and 13-19 with a reasonable expectation of success.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
First, the purpose of the of the Sanberg reference is not to remedy the deficiencies of Keirstead, neither is the purpose of the Weiss reference to remedy the deficiencies of Keirstead and Sanberg, etc. The purpose of Keirstead, Sanberg, Weiss and Bertilsson is to teach what is very well know in the prior art: that thyroid hormone receptor like triiodothyronine (T3, a thyroid hormone) promote survival and/or growth of glial cells in vitro.
True, none of the above references teaches the promotion of survival and/or growth of glial cells in vitro by administering the RXR agonist IRX4204 or its salts. That is why reference is made to Sanders.
None of the above references teaches all the limitations of claim 3, if that were the case, the rejection would have been a 102 instead of a 103. It is the combination of the above references that makes the claim obvious.
Second, selecting a proper salt of a known pharmaceutical compound is very important for the in vivo administration, since the proper salt will increase the solubility and bioavailability required for the drug to reach the proper target within the human body. However, salts are not that critical for in vitro experiments wherein there is a direct contact between the drug and the target (in the instant case the glial cell). The selection of a salt can definitively helps with the solubility of the drug (i.e. more or less drug in solution), but at the end of the day it will not alter significantly its biological properties. In other words, most if not all the known salts of the compound IRX4204 will still be RXR agonists and will have the same or similar effects on glial cells.
Claim Objections
Claims 4-6 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
April 21, 2026.
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