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 .
Applicant's amendments filed 11/13/2024 have been entered.
Claims 11, 12, 14-27, 44 are pending.
Claim Rejections - 35 USC § 112
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 11, 12, 14-27, 44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Ex parte Forman (230 USPQ 546, BdPatApp & Int.) and In re Wands (858 F.2d 731, 8 USPQ2d 1400, 1404, Fed. Cir. 1988) provide several factors in determining whether the specification of an application allows the skilled artisan to practice the invention without undue experimentation. Having said factors in mind, the instant specification fails to reasonably provide enablement for methods of preventing the claimed conditions. Specifically, the instant invention is directed to the prevention of mitochondrial diseases including those genetic mitochondrial diseases such as, but not limited to, Alper's disease; Kearns-Sayre syndrome (KSS); Leigh-like syndrome; maternally inherited Leigh syndrome (MILS); mitochondrial depletion syndrome (MDS); mitochondrial DNA depletion syndrome (MDDS), maternally inherited diabetes and deafness (MIDD), dominant optic atrophy (DOA), LCAD, VLCAD, MNGIE, Duchenne muscular dystrophy, congenital myopathies, disorders of purine and/or pyrimidine synthesis, DiGeorge syndrome among others.
In the instant case, the burden of enabling for preventing genetic mitochondrial diseases requires appropriate screening testing, subsequent data compilation, and finally appropriate data analysis, to assess and properly enable one skill in the art whether such diseases are prevented from formation in a patient. For example, the specification must provide adequate guidance whether the genetic mitochondrial diseases encompassed in the claims can be prevented from forming in a patient, once the composition is administered to a subject susceptible to develop such diseases.
Moreover, the specification must provide direct evidence associating the claimed prevention to the composition applied. The burden of showing preventative properties is greater than that of enabling a treatment, because one of ordinary skill in the art must not only show competent screening of those subjects susceptible to such conditions, but also show that the efficacy of a preventative method is directly caused by applying or administering the instantly claimed composition to the susceptible subjects.
In this case, there is no teachings for screening methods identifying susceptible subjects nor is there any direct evidence of efficacy establishing a preventative property associated with the claimed composition. Furthermore, the state of the prior art concerning methods of preventing any genetic disease is not well described (see Genetic Disorders by Cleveland Clinic, https://my.clevelandclinic.org/health/diseases/21751-genetic-disorders?view=print, Prevention Section). It clearly states that “There is often little you can do to prevent a genetic disorder. But genetic counseling and testing can help you learn more about your risk. It can also let you know the likelihood of passing some disorders on to your children“. In other words, it is impossible to prevent genetic diseases even in 2021, which is the publication date of the article. Accordingly, undue experimentation is necessary to determine screening and testing protocols to demonstrate the efficacy of the presently claimed invention.
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.
Claim 14 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites the broad recitation “collagen VI muscular dystrophies”, and the claim also recites “Ullrich congenital muscular dystrophy, Bethlem myopathy, oculopharyngeal distal, and Emery-Dreifuss” which is the narrower statement of the range/limitation; the claim also recites a broad limitation “autoimmune diseases of the skin”, and the claim also recites “pemphigus vulgaris and lupus”, which is the narrower statement of the range/limitation. In addition, the claim also recites a broad limitation “neuromuscular disorders”, and the claim also recites “limb-girdle muscular dystrophy, inflammatory myopathies, Charcot Marie Tooth (CMT) neuropathy, and drug-induced peripheral neuropathies”, which is the narrower statement of the range/limitation The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAN MING R HUI/ Primary Examiner, Art Unit 1627
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