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 1-11 are pending.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Instant application is a U.S. National Stage entry of PCT/IB2020/062306, filed 12/21/2020. PCT/IB2020/062306 claims priority of the foreign application PT116069, filed 01/22/2020. Therefore, the effective filing date is 01/22/2020.
Claim Objections
Claims 2, 3, 8, and 11 are objected to because of the following informalities:
Claim 2 reads “in improvement locomotor function” and should read “in the improvement of locomotor function”
Claim 3 reads “wherein the spinal cord injury is in acute phase” and should read “wherein the spinal cord injury is in an acute phase”
Claim 8 reads “wherein the spinal cord injury is in acute phase” and should read “wherein the spinal cord injury is in an acute phase”
Claim 11 is missing punctuation at the end of the claim
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are “use” claims, which are not directed to composition or the method itself.
For the sake of compact prosecution, claims 1-8 will be interpreted as Eletriptan Hydrobromide or a pharmaceutical composition thereof, and the “for use” will not be given patentable weight.
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 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01.
The claims are “use” claims which could be construed as method claims which omit the essential step of administration of the composition.
For the sake of compact prosecution, claims 1-8 will be interpreted as Eletriptan Hydrobromide or a pharmaceutical composition thereof, and the “for use” will not be given patentable weight.
Claim 11 is 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.
Regarding claim 11, the phrases "preferably" and “more preferably” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Isacson et al. (US 20130274235 A1).
Regarding instant claims 1-8, Isacson et al. teaches, eletriptan hydrobromide as a 5-HT agonist.
Regarding instant claim 9, Isacson et al. teaches, in claims 3 and 8, a method of treating spinal muscular atrophy, spinobulbar muscular atrophy, and amyotrophic lateral sclerosis (ALS), which highly affects the spinal cord (paragraph [0080]).
Page 5 of instant specification states: “As used herein, spinal cord injury (SCI) refers to damage to any part of the spinal cord or nerves resulting from trauma (e.g. a car crash) or from disease or degeneration (e.g. cancer), that causes temporary or permanent changes in its function”. Therefore, a degenerative disease, such as ALS, which damages the spinal cord would read on the instant claims.
Table 1, on page 10, teaches that Eletriptan hydrobromide has a significant inducing effect on IGF-II expression in primary spinal cord cultures and is useful for treating motor neuron disease. The methods are taught, in claim 1, to treat motor neuron diseases in humans, as in instant claim 11.
Claim 10 is objected to as being dependent upon a rejected claim.
Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Basbaum et al. (WO 2008024930 A2).
Regarding instant claims 1-8, Basbaum et al. teaches, in claim 2, a composition of eletriptan. It is taught on page 15 that the compounds are typically administered as pharmaceutically acceptable salts, including hydrobromic salts.
Regarding instant claims 9 and 11, Basbaum et al. teaches, in claims 10 and 11, a method of treating lumbar plexopathy in humans comprising administering eletriptan hydrobromide. Lumbar plexopathy is an injury to the lumbar or sacral nerves of the spinal cord, which reads on the instant claims in view of the instant specification. Eletriptan hydrobromide is also taught, in claim 12, to treat Friedreich’s ataxia, which causes damage to the spinal cord and peripheral nerves.
Claim 10 is objected to as being dependent upon a rejected claim.
Advisory Notice
Claim 10 appears allowable if written in independent form. The prior art does not teach or suggest the administration of eletriptan hydrobromide 1 hour after injury.
Conclusion
Claims 1-9 and 11 are rejected.
Claim 10 is objected to.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 9-5.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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