DETAILED ACTION
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 .
Status of the Claims
Claims 1-13 are pending and under current examination.
Claim Rejections - 35 USC § 112
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 3, 5, 10, and 13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 is indefinite because the claim requires an amount of L-Dopa, but limits this amount in terms of mg/kg body weight. As the body weight of the individual receiving the L-Dopa is totally unknown, the actual amount of this substance required by the claim is also unknown and the claim is therefore indefinite under 35 USC 112(b).
Claim 5 is indefinite because the claim limits the ratio of ethanol to glycerol without indicating the type of ratio (e.g. wt/wt or molar). Therefore the relative proportions of these two substances required by the claim is unclear.
Claim 10 is indefinite because the claim limits the ratio of ethanol to glycerol without indicating the type of ratio (e.g. wt/wt or molar). Therefore the relative proportions of these two substances required by the claim is unclear.
Claim 13 is indefinite because the claim limits the ratio of ethanol to glycerol without indicating the type of ratio (e.g. wt/wt or molar). Therefore the relative proportions of these two substances required by the claim is unclear.
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.
Claims 1-4, 6-9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 9987237; issue date: 06/05/2018; cited in the IDS filed 10/27/2023).
With regard to claims 1, 6 and 7, Chen teaches a method for treating Parkinson’s disease (col 2, line 18; col 26, line 40) comprising administering a composition comprising both isoperillyl alcohol (i.e. perillyl alcohol; col 4, lines 50-60) and L-Dopa (i.e. concurrent administration; table 1, col 23-24). The composition can be formulated for nasal delivery (abstract; col 28, lines 1-3) to a mammal (col 30, line 35). While Chen’s examples focus on conjugates of perillyl alcohol, the broader disclosure embraces delivering perillyl alcohol itself with another active agent. See .e.g. col 4, lines 23-25: “[t]he present invention provides for methods of treating a disease … using an isoperillyl alcohol or a derivative of an isoperillyl alcohol.”
Although Chen does not disclose a single example falling entirely within the scope of the instant claims, Chen teaches every limitation and therefore the invention as claimed would have been prima facie obvious to the artisan of ordinary skill as of the instant effective filing date.
With regard to claim 2, the monoterpene (i.e. the perillyl alcohol) may be present in amounts ranging from about 1-20% (col 5, lines 25-30). This range overlaps with the range recited in the instant claims (see MPEP 2144.05: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)).
With regard to claim 3, the examiner notes that the claim as it is currently worded does not actually place any limitation on the amount of L-Dopa in the composition. Additionally, Chen directs the artisan of ordinary skill to use a therapeutically effective amount (col 27, lines 28-46). It would have been a matter of routine for one of ordinary skill to optimize the dose of L-Dopa to achieve it’s intended effect of improving Parkinson’s disease by testing several doses. See MPEP 2144.05(II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) .
With regard to claims 4, 8, and 11, the compounds noted above are mixed with a pharmaceutically acceptable carrier (col27, lines 5-6).
With regard to claims 9 and 12, as noted above, the composition may be administered intranasally.
Claims 5, 10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 9987237; issue date: 06/05/2018; cited in the IDS filed 10/27/2023) as applied to claims 1-4, 6-9, 11, and 12 above, and further in view of Chen et al. (US 20100226913; publication date: 09/09/2010).
With regard to claims 5, 10, and 13, the relevant disclosure of Chen ‘237 is set forth above. Chen ‘237 teaches that the carrier may include ethanol or glycerol (col 27, line 19), but does not disclose that ethanol and glycerol are present in a 1:1 ratio.
Chen ‘913 discloses a specific embodiment, the composition comprises, or alternatively consists essentially of, or yet further consists of a therapeutic agent, at least about 0.03% (v/v) of a monoterpene such as perillyl alcohol or an analog thereof; at least about 2.6% total of a co-solvent which can be 1.3% (v/v) of a polyol such as glycerol or an equivalent thereof; and at least about 1.3% of ethanol (0005).
It would have been prima facie obvious to formulate the Chen ‘237 formulation containing perillyl alcohol and glycerol to also contain ethanol and glycerol as cosolvents at a 1:1 because such a formulation had been shown to be effective for perillyl delivery as of the instant effective filing date. See MPEP 2144.07 regarding the obviousness of art-recognized suitability.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617