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
Status of the Claims
Claims 1-7 are pending and are examined on their merits.
Claim Interpretation
Examiner notes that applicant does not use “solvent,” in the standard meaning it is conveyed to have in the art, but defines it to be “the other substances which are included in the topical medication, which are chemically compatible with the active ingredient to act as a carrier producing a mixture of sufficiently uniform properties to enable consistent dosing of the patient with the active ingredient.” Therefore, the term will be interpreted as such. For example, claim 1, “a transdermal therapy for patients comprising donepezil and a solvent,” will be interpreted as “a transdermal therapy for patients comprising donepezil and a pharmaceutically acceptable carrier.”
Claim 4 includes the phrase, “comprises a coloring.” For the purpose of examination, the phrase will be read as “comprises a colorant.”
Claim 7 includes the phrase, “by linking to the other medications to the solvent.” For the purpose of examination, the phrase will be read as “by linking the other medications to the solvent.”
Claim Rejections - 35 USC § 112(b)
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 7 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.
Claim 7 is indefinite for the phrase “wherein the composition of the solvent is such that the solvent can be used as a delivery method for other medications by linking the other medications to the solvent via dispersion bonding,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the composition of claim 1. Specifically, it is unclear how the composition of the solvent is further limited by the phrase. The specification does not provide guidance as to how the phrase further limits the composition of claim 1. For the purpose of examination, the phrase will be interpreted with its plain-language meaning (i.e. a solvent capable of inducing a temporary dipole moment in the administered medication; Examiner notes that such activity is present between all molecules, whether polar or nonpolar).
Claim Rejections - 35 USC § 102
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 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 1-4 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hsu (US 2002/0192243 A1 published on December 19th 2002).
Claim 1 is directed to a transdermal therapy comprising donepezil and a solvent.
Hsu teaches a transdermal composition comprising an Alzheimer’s drug, an inorganic base at a pH of 8-13, and carriers (Hsu, pg. 13, claim 34), wherein the drug is donepezil (Hsu, pg. 13, claim 46). Hsu additionally teaches that the inorganic base is selected from ammonium hydroxide, sodium hydroxide, potassium hydroxide, and magnesium hydroxide, each of which are typically present in a solution of water (i.e. a solvent). Hsu therefore is anticipatory of claim 1.
Claim 2 requires that the therapy of claim 1 is in the form of a gel, cream, or gel-cream. Hsu teaches gels and creams (Hsu, pg. 13, claim 39), anticipating claim 39.
Claim 3 requires that the solvent of claim 1 additionally has water. Claim 3 is therefore anticipated by Hsu for the same reasons as claim 1.
Claim 4 further limits the therapy of claim 1 to comprise a colorant. Hsu teaches a colorant (Hsu, pg. 8, paragraph [0087]), anticipating claim 4.
Claim 7 further limits the therapy of claim 1 to require that the composition of the solvent can be used as a delivery method for other medications by linking the other medications to the solvent via dispersion bonding. As claim 7 is indefinite (see the above 112(b) rejection, it is being interpreted as requiring a solvent capable of inducing a dipole moment in the donepezil. As water is capable of inducing a dipole moment in donepezil (such induced dipole moments are present between the shifting electron clouds of all molecules), claim 7 is anticipated by Hsu.
Claims 1-4 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sozio (Sozio et al., (2012). Transdermal donepezil on the treatment of Alzheimer’s disease. Neuropsychiatric Disease and Treatment, 8, 361–368).
Sozio teaches a transdermal donepezil therapy (Sozio, pg. 365) that comprises a solvent (Sozio, pg. 364, Table 3), anticipating claim 1.
Claim 5 is directed to a method of applying the therapy of claim 1 once a day to skin above skeletal muscle. Sozio teaches application to upper back, upper middle arm, and side of torso (Sozio, pg. 366), as well as an application of one-day-at-a-time (Sozio, pg. 366, first paragraph), anticipating claim 5.
Claim Rejections - 35 USC § 103
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.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Sozio (Sozio et al., (2012). Transdermal donepezil on the treatment of Alzheimer’s disease. Neuropsychiatric Disease and Treatment, 8, 361–368).
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Claim 6 limits application of the therapy of claim 1 to twice a day to skin above skeletal muscle.
For the teachings of Sozio as they are relevant to claim 1 see the above 102 rejection over claim 1. Sozio teaches application to upper back, upper middle arm, and side of torso (Sozio, pg. 366). Sozio does not explicitly teach administration twice daily. However, one of ordinary skill in the art would have a reasonable expectation of success in administering a transdermal donepezil therapy twice daily, because such an administration method would be obvious to try. Specifically, administration both in the morning and evening is one of the most common medication administration timelines. Claim 6 is therefore prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629