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 .
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 1-3 and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luecking et al. (DE 10239042). The claims read on the compounds A and B on page 30, and the compound 7.5 in page 33 of the reference. These anticipatory compounds are depicted below.
RN 666719-35-3 CAPLUS
CN 2,4,8,14,21-Pentaazatricyclo[14.3.1.13,7]heneicosa-
1(20),3,5,7(21),16,18-hexaen-15-one, 6-bromo-(CA INDEX NAME)
PNG
media_image1.png
238
334
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RN 666719-36-4 CAPLUS
CN 2,4,8,14,21-Pentaazatricyclo[14.3.1.13,7]heneicosa-
1(20),3,5,7(21),16,18-hexaen-15-one (CA INDEX NAME)
PNG
media_image2.png
230
300
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Greyscale
RN 666719-41-1 CAPLUS
CN 2,4,8,13,20-Pentaazatricyclo[13.3.1.13,7]eicosa-1(19),3,5,7(20),15,17-
hexaen-14-one (CA INDEX NAME)
PNG
media_image3.png
228
293
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Greyscale
.
Note, the intended use of a pharmaceutical composition does not carry patentability weight.
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.
Claim 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Luecking et al. (DE 10239042). The reference teaches a generic group of compounds which embraces applicants’ claimed compounds (See Abstract and pages 1-2, compounds of formula (I) and definitions of the variables). The claims differ from the reference by reciting specific species and a more limited genus than the reference. However, it would have been obvious to one having ordinary skill in the art at the time of the invention to select any of the species of the genus taught by the reference, including those instantly claimed, because the skilled chemist would have the reasonable expectation that any of the species of the genus would have similar properties and, thus, the same use as taught for the genus as a whole. One of ordinary skill in the art would have been motivated to select the claimed compounds from the genus in the reference since such compounds would have been suggested by the reference as a whole. It has been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).
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 12 and 13 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 claims contain 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 use the invention.
It has been recited in claim 12, a method of treating or alleviating neurodegenerative disease. There is no such agent which can treat neurodegenerative diseases generally. That is because neurodegenerative disorders are extremely varied in origin and nature of effect. The origin and the nature of many neurodegenerative diseases such as Huntington’s disease, Pick’s disease, Frontotemporal dementia, Cerebro-Oculo-Facio-Skeletal (COFS) syndrome (cranofacial and skeletal abnormalities), Motor neuron disease (muscle weakness), Corticobasal ganglionic degeneration, Creutzfeldt-Jacob disease (fatal disease), Dementia with Lewy bodies, and Progressive supranuclear palsy Dementia are different one from the other. Many neurodegenerative disorders are untreatable to this day.
The symptoms and nature of these diseases are also different one from the other. It can be shown that many of these neurodegenerative disorders have different origin and nature of effect. Some neurodegenerative disorders are hereditary (Charcot-Marie-Tooth disease). Many neurodegenerative disorders vary in how they affect the body and its functions. Diseases such as Cerebral palsy, and Parkinson’s disease affect the movement of the patient. Diseases such as Alzheimer’s disease affect the memory of the patient.
Applicants have not demonstrated, nor have they alleged there is any correlation between the in vitro assays they disclose in pages 37-41 and clinical efficacy against any disease. Case law is clear on this point. In an unpredictable art, such as neurodegenerative disease treatment, in vitro assays may be used for enablement only if there is a well-established correlation between the assay and clinical efficacy.
The specification does not reasonably provide enablement for treating or alleviating Parkinson's disease, Alzheimer's disease, Huntington's disease, Pick's disease, Amyotrophic lateral sclerosis, Prion disease, Motor neuron disease, Spinocerebellar ataxia, Spinal muscular atrophy, Creutzfeldt-Jakob disease, or Alcohol related dementia.
The how to use requirement of the enablement statute, when applied to method claim, refers to operability and how to make the claimed method work “The factors to be considered (in making an enablement rejection) have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims”, In re Rainer 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. The issue is the correlation between clinical efficacy for Parkinson's disease, Alzheimer's disease, Huntington's disease, Pick's disease, Amyotrophic lateral sclerosis, Prion disease, Motor neuron disease, Spinocerebellar ataxia, Spinal muscular atrophy, Creutzfeldt-Jakob disease, or Alcohol related dementia, and Applicants' in vitro assays.
a) Determining if any particular claimed compound would treat Parkinson's disease, Alzheimer's disease, Huntington's disease, Pick's disease, Amyotrophic lateral sclerosis, Prion disease, Motor neuron disease, Spinocerebellar ataxia, Spinal muscular atrophy, Creutzfeldt-Jakob disease, or Alcohol related dementia would require synthesis of the compound, formulation into a suitable dosage form, and subjecting it to clinical trials with a number of fundamentally different diseases listed above, or to testing them in an assay known to be correlated to clinical efficacy of such treatment. This is a large degree of experimentation.
b) The direction concerning treating these diseases found in the specification merely states Applicants' intention to do so. Since no single compound has ever been used to treat these diseases how is the skilled physician to know what dose to use for each of these different diseases?
c) There is no working example of treatment of any rejected disease in man or animals.
d) The nature of the invention is clinical treatment of disease with inhibitors of LRRK2, which involves physiological activity.
e) The state of the clinical arts in the treatment of neurodegenerative diseases is extensive with no single report of success of treating them generally using a s ingle drug.
f) The artisan using Applicants invention would be a physician with an MD degree and several years of experience.
g) It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved”, and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ l8, 24 (CCPA 1970).
h) The scope of the claims involves all of the hundreds of compounds as well as the myriads of diseases embraced by the claims. Thus, the scope of the claim is very broad. The scope of uses embraced by these claims is not remotely enabled based solely on instant compounds ability to inhibit LRRK2.
MPEP 2164.0l(a) states, “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).” That conclusion is clearly justified here, and undue experimentation will be required to practice Applicants' 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.
Claims 1-13 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.
i) In the definition of R4, the group “3 to 7 membered heterocycloalkyl” is present. This is not normal nomenclature. Is a saturated 3-7 membered heterocycle intended or is a heteroatom attached to a heterocycle or is an alkyl attached to the heterocycle? A clarification is required as to which atoms are present, how many of each may be present, how many rings may be present, what the degree of saturation is and what size ring is intended.
ii) In claim 6, the phrase “one selected from the following group of compounds” should be rewritten using proper Markush language, such as, “selected from the group consisting of” and insertion of “and” before the last compound. Alternative and singular language is required.
iii) Claim 7 has been improperly presented. Is it a dependent or independent claim? Appropriate correction is required. Language, such as, “A method for preparing a compound of formula I according to claim 1” if a dependent claim is intended or a complete definition of all of the variables if an independent claim is intended. An independent claim cannot depend on any other claim for definitions.
iv) Claims 8-10 are duplicates of each other because the intended use of a pharmaceutical composition does not carry patentability weight. A pill is a pill no matter what it is used for.
v) Regarding claim 11, the additional component in the “functional food composition” is not given. What is intended here? Also, the intended use here also does not carry patentability weight.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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September 18, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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