DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 4-5 and 23 have been canceled.
Claims 1-3 and 6-22 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group III, Claims 3, 6-10, 13-18, and 21-22, and without traverse of species Steele-Richardson-Olszewski syndrome, and deuterated linoleic acid, in the reply filed on 6/26/2026 is acknowledged.
Claims 1-2 and 8-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Note: Applicant was asked to elect a single discrete and disclosed species of a deuterated polyunsaturated fatty acid or ester or derivative thereof. However, applicant’s species election did not specify the deuterated position. Therefore, claims 8-10 and 13-18 have been properly withdrawn.
Claims 3, 6-7 and 21-22 are being examined in this application, insofar as they read on the elected species of Steele-Richardson-Olszewski syndrome, and deuterated linoleic acid.
Claim Objections
Claims 21-22 are objected to because of the following informalities:
Claim 21, the recitation of “the one or more deuterated PUFA or ester or derivative thereof” on line 1-2 is suggested to read “the one or more deuterated PUFAs or esters or derivatives thereof”.
Claim 22, the recitation of “the antioxidant” on line 1 is suggested to read “the at least one antioxidant”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
(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 3, 6-7 and 21-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating, ameliorating, or inhibiting progression of Steele-Richardson-Olszewski syndrome in a subject in need thereof, by administering D2-Lin and D2-ADA and esters thereof, does not reasonably provide enablement for a method of treating, ameliorating, or inhibiting progression of Steele-Richardson-Olszewski syndrome in a subject in need thereof, by administering deuterated polyunsaturated fatty acids or esters or derivatives thereof other than D2-Lin and D2-ADA and esters thereof instantly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
The breadth of the claims – The breadth of the claims is drawn to a method of treating, ameliorating, or inhibiting progression of Steele-Richardson-Olszewski syndrome in a subject in need thereof, by administering D2-Lin and D2-ADA and esters thereof.
The Nature of the invention – The nature of the invention is drawn to the administration of D2-Lin and D2-ADA and esters thereof for treating, ameliorating, or inhibiting progression of Steele-Richardson-Olszewski syndrome in a subject in need thereof.
The state of the prior art / The predictability or lack thereof in the art – The state of the prior art is that the pharmacological art involves screening in vitro and in vivo of the selected composition to determine the desired pharmacological activities (i.e. what compositions can treat which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The relative skill of those in the art – The relative skill of those in the art is high, with a typical practitioner possessing commensurate degree level, as well as several years of professional experience.
The amount of direction or guidance present – There is no direction or guidance present for the treatment of Steele-Richardson-Olszewski syndrome, by administering deuterated polyunsaturated fatty acids or esters or derivatives thereof other than D2-Lin and D2-ADA and esters thereof.
The instant specification, para 0132-0136, demonstrate dosing regimens of D2-Lin ester and D2-ADA ester. In addition, Example 8 is provided in the instant specification for treating Steele-Richardson-Olszewski syndrome by administering D2-Lin.
The presence or absence of working examples – The working examples present in the instant specification are directed to treating patients having Steele-Richardson-Olszewski syndrome with D2-Lin and D2-ADA and esters thereof, as disclosed in para 0132-0136 and Example 8. There is no working examples present for the treatment of Steele-Richardson-Olszewski syndrome by administering deuterated polyunsaturated fatty acids or esters or derivatives thereof other than D2-Lin and D2-ADA and esters thereof as instantly claimed.
In addition, that any deuterated polyunsaturated fatty acids or esters or derivatives thereof can be used to treat Steele-Richardson-Olszewski syndrome embraced by the claims is an incredible finding for which Applicant has not provided supporting evidence. Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for treating Steele-Richardson-Olszewski syndrome by administering the instant claimed deuterated polyunsaturated fatty acids or esters or derivatives thereof, which encompass a wide array of products.
The quantity of experimentation needed – The quantity of experimentation needed is undue experimentation. One of skill in the art would need to synthesize all deuterated polyunsaturated fatty acids or esters or derivatives thereof instantly encompassed by the claims and would furthermore then have to determine which deuterated polyunsaturated fatty acids or esters or derivatives thereof in the instant invention would provide treatment of Steele-Richardson-Olszewski syndrome. Such a task has yet to be accomplished in the art and the instant specification provides no particular guidance on how to accomplish such a task.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
Genetech, 108 F.3d at 1366, states that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which deuterated polyunsaturated fatty acids or esters or derivatives thereof encompassed in the instant claims would treat Steele-Richardson-Olszewski syndrome, with no assurance of success.
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 6-7 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 pre-AIA the applicant regards as the invention.
Claim 6, line 1-2, recites the limitation “the deuterated PUFA or ester or derivative thereof”. Claim 6 is dependent from claim 3, and claim 3 recites “one or more deuterated polyunsaturated fatty acids (PUFAs) or esters or derivatives thereof”. It is unclear which deuterated PUFA or ester or derivative thereof is being claimed in claim 6. Applicant may amend claim 6 to recite “the one or more deuterated PUFAs or esters or derivatives thereof” to overcome this rejection.
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 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 of this title, 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.
Claims 3, 6-7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Schweiger et al (US 2012/0184624 A1; 7/19/2012.) in view of Albers et al (Trends in Neurosciences. 2001;24(6):347-352.) and Shchepinov (US 2011/0105609 A1; 5/5/2011. Cited on IDS).
The instant claims recite a method of treating, ameliorating, or inhibiting progression of Steele-Richardson-Olszewski syndrome in a subject, the method comprising: administering a first effective amount of one or more deuterated polyunsaturated fatty acids (PUFAs) or esters or derivatives thereof lipids or pharmaceutically acceptable salts thereof to the subject during a first period of time.
Schweiger teaches a method of treating Progressive supranuclear palsy (Steele-Richardson-Olszewski syndrome) (para 0010), comprising administering an effective amount of compounds including Linoleic acid (para 0011, 0017) or pharmaceutically acceptable salt (para 0020). The method further comprises administering antioxidants (para 0039), wherein said compounds including Linoleic acid are co-administered with said antioxidants (para 0013, 0020).
Schweiger does not teach the method wherein said Linoleic acid is deuterated (claim 3), at least one or more of the bis-allylic positions of the deuterated Linoleic acid is a site of deuterium substitution (claim 6), and deuterium substitution is at at least one further allylic site (claim 7).
However, Schweiger does teach the method is for treating Progressive supranuclear palsy. Before the effective filing date of the claimed invention, it was well-known in the art that oxidative damage plays a critical role in the pathogenesis of Progressive Supranuclear Palsy, and that oxidative stress causes oxidative damage to brain tissue (Fig. 4, p.348 col right – para 3), as evidenced by Albers. In addition, Shchepinov teaches brain tissue is particularly rich in polyunsaturated fatty acids (PUFAs), which constitute 35% of the phospholipids in the neuronal membranes of the brain, three particularly important fatty acids, which are abundant in neuronal membranes include linoleic acid (para 0032). Shchepinov teaches an isotopically modified PUFA molecule may contain two deuterium atoms (para 0081), e.g., deuterated linoleic acid (para 0089), the essential PUFAs isotope reinforced at bis-allylic positions will be more stable to the oxidation (para 0084), and PUFAs that are isotopically reinforced at either one, several, or all bis-allylic positions are useful for the treatment of neurological disorders in which PUFA oxidation is a factor (para 0074, 0098).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate deuterated linoleic acid, since Schweiger discloses a method of treating Progressive supranuclear palsy comprises administering linoleic acid, Albers discloses that oxidative damage is an important contributor to degeneration in progressive supranuclear palsy, and Shchepinov discloses that deuterated linoleic acid will be more stable to the oxidation, and that PUFAs including linoleic acid, isotopically reinforced at bis-allylic positions, are useful for the treatment of neurological disorders in which PUFA oxidation is a factor. In other words, one of ordinary skill in the art would have been motivated to treat neurological disorders such as Progressive supranuclear palsy by administering deuterated linoleic acid, since deuterated linoleic acid will be more stable to the oxidation, as evidenced by cited references above. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references to incorporate deuterated linoleic acid with a reasonable expectation for successfully treating Progressive supranuclear palsy.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Schweiger et al (US 2012/0184624 A1; 7/19/2012.) in view of Albers et al (Trends in Neurosciences. 2001;24(6):347-352.) and Shchepinov (US 2011/0105609 A1; 5/5/2011. Cited on IDS) as applied to claims 3, 6-7 and 21 above, further in view of Stamelou et al (Movement Disorders. 2008;23(7):942-949.).
References cited above do not teach the claimed antioxidant (claim 22).
However, Schweiger does teach the method of treating Progressive supranuclear palsy comprises administering antioxidants. Stamelou teaches CoQ10 (an antioxidant) appears to improve cerebral energy metabolism in Progressive supranuclear palsy, long-term treatment might have a disease-modifying, neuroprotective effect (Abstract, p.949 col left – para 2).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate CoQ10, since Schweiger discloses a method of treating Progressive supranuclear palsy comprises administering antioxidants, and Stamelou discloses that CoQ10, an antioxidant, leads to a mild clinical amelioration and improves cerebral energy metabolism in Progressive supranuclear palsy. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate CoQ10 (an antioxidant) with a reasonable expectation for successfully treating Progressive supranuclear palsy.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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