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 .
Election/Restrictions
Applicants’ election without traverse of Compound 29 in the reply filed on August 6, 2026, is acknowledged. The search and examination have been expanded to embrace the entire claims as currently presented.
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 2, 4-6 and 10-20 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 claim 2, the phrase “wherein the general structure thereof is as follows” should be deleted because the structural formula and definitions of the variables fully define the compound of formula II. The term “general” implies more that what is being recited by the claim language.
ii) The groups alkyl and alkoxy are optionally substituted then further substituted by at least one halogen or hydroxyl. The nature of the first intended “substituent(s) is not known. A clarification is required. The term “substituted” without saying which substituents are intended is indefinite. One skilled in the art cannot say which substituents are permitted and which ones are not.
iii) In claim 6, the phrase “specifically selected from the following compounds” should be rewritten using proper Markush language of presenting the alternatives in singular form. Thus, the phrase “selected from the group consisting of” is suggested. The term “selectively” is superfluous or extraneous.
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 11-20 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.
Regarding claims 11 and 18, the how to use portion of the statute has not been met. This means that Applicants must teach the skilled practitioner, in this case a physician, how to treat a given subject. One skilled in the art should know which disease is treatable by targeting cathepsin K. The physician clearly must know what diseases and what symptoms are to be treated. In this case, Applicants have not provided what is being treated by these claims, who the subject is, how one can identify said subject (i.e. how one can identify a subject in need), given no specific dose, given no specific dosing regimen, given no specific route of administration, and do not specify what diseases or symptom they intend to treat.
Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
As the Supreme Court said in Brenner v. Manson, 148 USPQ at 696: “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” As U.S. Court of Customs and Patent Appeals stated In re Diedrich 138 USPQ at 130, quoting with approval from the decision of the board: “We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates.”
Claims 12-16 and 19 are rejected under 35 U.S.C. 112, first paragraph, because the specification does not reasonably provide enablement for treating a disease wherein the disease comprises a tumor, a thyroid diseases, a cardiovascular disease, a bone disease, or a gum disease.
The dependent claims limit the thyroid disease is hyperthyroidism, the cardiovascular disease to atherosclerosis, cardiac hypertrophy or heart failure; the bone disease to osteoporosis, osteoarthritis, or rheumatoid arthritis; the gum disease to gingivitis or periodontitis.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
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 treating diseases and Applicants' assays disclosed in the specification.
a) Determining if any particular claimed compound would treat a tumor, a thyroid diseases, a cardiovascular disease, a bone disease, or a gum disease 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 inhibitor of cathepsin K activity has ever been used to treat tumor, a thyroid diseases, a cardiovascular disease, a bone disease, or a gum disease generally how is the skilled physician to know what dose to use for each of these different diseases? Applicants do not assert, and it is not art-recognized that the in vitro assay of the specification is correlated to clinical efficacy of the diseases objected to.
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 diseases with inhibitors of cathepsin K, which involves physiological activity.
e) The state of the clinical arts in the Cathepsin K activity related diseases is extensive with reports of only potential of treating osteoporosis.
f) The artisan using Applicants invention would be a physician with a 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 treating hundreds of diseases embraced by the claims. Some diseases embrace “opposites” (thyroid diseases) and some embrace unrelated diseases (bone disease, cardiovascular disease). 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 the activity of cathepsin K.
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 method of treating osteoporosis is enabled.
Allowable Subject Matter
Claims 4, 5, 10, 17 and 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 2 and 6 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
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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September 21, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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