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 January 13, 2026.
Status of Claims
Amendment of claims 3 and 10-13 and 14-18 is acknowledge
Claims 1-19 are currently pending and are the subject of this office action.
Claim 1-2 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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 3-19 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Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.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 (New Rejection not 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.
1) Claim(s) 3, 7-11, 13-14 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keirstead et. al. (US 7,285,415), Sanberg et. al. (US 2002/0028510), Weiss et. al. (US 2007/0009491), Bertilsson et. al. (US 2005/0009742) and Sanders et. al. (Neurology (April 2014) 82(10 Supplement) pages 1-6).
For claims 3, 7-9, 13-14 and 16-19, 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. 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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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 their 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).
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, 7-9, 13-14 and 16-19 with a reasonable expectation of success.
For claims 10-11, the prior art does not teach salts or esters of the RXR agonist IRX4204. However, it is well known that salts and esters of known compounds are very likely to retain the same or similar biological properties, thus resulting in the practice of claims 10-11 with a reasonable expectation of success.
2) Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keirstead et. al. (US 7,285,415), Sanberg et. al. (US 2002/0028510), Weiss et. al. (US 2007/0009491), Bertilsson et. al. (US 2005/0009742) and Sanders et. al. (Neurology (April 2014) 82(10 Supplement) pages 1-6) as applied to claims 3, 7-11, 13-14 and 16-19 above, further in view of Noelle (US 2010/0183575).
The prior art teaches all the limitations of claim 12, except for the RXR agonist being bexarotene. However, Noelle teaches that bexarotene is a RXR agonist (see [0057]).
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 substitute one functional equivalence (any RXR agonist) for another (bexarotene) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claim 12, with a reasonable expectation of success.
Claim Rejections - 35 USC § 112 (New Rejection not Necessitated by Amendment).
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 3-6 and 9-19 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for the promotion of survival or growth of glial cells in vitro, it does not reasonably provide enablement for the promotion of survival or growth of neurons in vitro.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention
Claims 3-6 and 9-19 recite a method for the promotion of survival or growth of neurons and glial cells in vitro comprising administering to a neuron or a glial cell a composition comprising a combination of a RXR agonist, a thyroid hormone, and optionally, a neurotrophic factor.
2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
3. The state and predictability of the art
A search of the literature shows that RXR agonists and thyroid hormones are known to promote the survival or growth of glial cells in vitro (see above 103 rejection). However, there is no prior art disclosing the same for neurons.
4. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 states: “The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work”.
In the instant case, the specification teaches a method to promote the survival or growth of glial cells in vitro (see specification Example 18 on page 51). However, there is no data regarding a method to promote the survival or growth of neurons in vitro. The results obtained for glial cells cannot be correlated with neurons.
As such, if there is no correlation, then the examples do not constitute working examples.
While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as to promote the survival or growth of neurons in vitro, is required for practice of the claimed invention.
5. The quantity of experimentation necessary
As discussed above (see: 3. the state and predictability of the art), there is no prior art data showing that either RXR agonist or thyroid hormones will promote the survival or growth of neurons in vitro. Based on this, and since applicant provides only data for promote the survival or growth of glial cells in vitro (see: 4. The amount of direction or guidance and the presence or absence of working examples above) it is expected that to determine if RXR agonists and/or thyroid hormones promote the survival or growth of neurons in vitro will require a whole new set of experiments. This is undue experimentation given the limited guidance and direction provided by Applicants.
6. Conclusion
Accordingly, the inventions of claims 3-6 and 9-19 do not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Conclusion
No claims are allowed.
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
January 16, 2026.