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 § 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 1-15 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) The phrase “an ester, a stereoisomer, a tautomer, a polymorph, a solvate, a metabolite, an isotopically labeled compound or a prodrug thereof” is indefinite for the following reasons. Regarding “an ester,” one skilled in the art cannot say what is intended. Is there an additional substituent, such as, -O-C(O)-R or -C(O)-O-R attached to the compound to make it an ester? Is this substituent in addition to what has been recited in the claim? Regarding “a polymorph,” it is unclear which one is intended or even if it is known that the compound exists in various polymorphic forms in the first place. Regarding “a solvate,” it is unclear which solvent crystallizes out as a solvate. It is unclear what the metabolite of the compound looks like. Regarding, “a prodrug,” this requires research. It is improper to require research to arrive at a given prodrug. Applicants should state what this looks like. The nature of the “isotopically labeled compound” is unknown because Applicants have not said which atom is present above the natural abundance.
ii) The group “heteroaryl” is indefinite because it is not known how many atoms are present, how many and what kind of heteroatoms are involved, what size ring is intended and how many rings are present. Similarly, the group “heterocyclyl” is indefinite because it is not known how many atoms make up the ring, which atoms are present and what kind of a ring (monocyclic, bicyclic, spiro, fused, bridged, saturated, etc.) is intended. The group “cyclohydrocarbyl” is also indefinite because the size, number of rings and degree of saturation is not known.
iii)The term “preferably” renders the claims indefinite because it is not clear whether the terms following the term are claim limitations. Such language is not permitted in the claims.
iv) Regarding claim 4-5, 7 and 15, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
v) Regarding claim 12, only one period at the end of a claim is required. The claim has periods after each numeral and the period is present before the last compound. Appropriate correction is required.
vi) Regarding claim 13, the compound according to claim 1 should be present in “an effective amount” for the pharmaceutical composition to work. Insertion of such phrase is suggested following “comprising.”
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 14 and 15 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.
The how to use portion of the statute has not been met for claim 14. This means that Applicants must teach the skilled practitioner, in this case a physician, how to prevent or treat a given disease. The physician clearly must know what diseases and what symptoms is to be prevented or treated. In this case, Applicants have not provided what is being prevented or treated by claim 14, 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 or prevent. One skilled in the art cannot say which disease is somehow related to HDAC6.
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.”
Claim 15 is rejected under 35 U.S.C. 112, first paragraph, because the specification does not reasonably provide enablement for treating or preventing cancer or proliferative diseases (e.g., lung cancer, colon cancer, breast cancer, prostate cancer, liver cancer, brain cancer, kidney cancer, ovarian cancer, stomach cancer, skin cancer, bone cancer, pancreatic cancer, glioma, glioblastoma, hepatocellular carcinoma, papillary renal carcinoma, head and neck squamous cell carcinoma, leukemia, lymphoma, myeloma, multiple myeloma, and solid tumors); Wilson's disease, spinocerebellar ataxia, prion disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis, amyloidosis, Alzheimer's disease, Alexander's disease, alcoholic liver disease, cystic fibrosis, Pick's disease, spinal muscular atrophy, or Lewy body dementia; rheumatoid arthritis, osteoarthritis; rheumatoid spondylitis; psoriasis; inflammatory bowel disease; chronic inflammatory lung disease, eczema, asthma, ischemia/reperfusion injury, ulcerative colitis, acute respiratory distress syndrome, psoriatic arthritis, infectious arthritis, progressive chronic arthritis, arthritis deformans, osteoarthritis, traumatic arthritis, gouty arthritis, Reiter's syndrome, polychondritis, acute synovitis and spondylitis, glomerulonephritis, hemolytic anemia, aplastic anemia, idiopathic thrombocytopenic purpura, neutropenia, ulcerative colitis, Crohn's disease, host-versus-graft disease, graft-versus-host disease, allograft rejection, chronic thyroiditis, Graves' disease, scleroderma, diabetes, active hepatitis, primary biliary cirrhosis, myasthenia gravis, multiple sclerosis (MS), systemic lupus erythematosus, atopic dermatitis, contact dermatitis, sunburn of the skin, chronic renal insufficiency, Stevens-Johnson syndrome, idiopathic steatorrhea, sarcoidosis, Guillain-Barre syndrome, uveitis, conjunctivitis, keratoconjunctivitis, otitis media, periodontal disease, pulmonary interstitial fibrosis, asthma, bronchitis, rhinitis, sinusitis, pneumoconiosis, pulmonary insufficiency syndrome, emphysema, pulmonary fibrosis, or silicosis.
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 this claim.
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 the disease recited and Applicants’ in vitro assays.
a) Determining if any particular claimed compound would treat, much less prevent cancer or proliferative diseases (e.g., lung cancer, colon cancer, breast cancer, prostate cancer, liver cancer, brain cancer, kidney cancer, ovarian cancer, stomach cancer, skin cancer, bone cancer, pancreatic cancer, glioma, glioblastoma, hepatocellular carcinoma, papillary renal carcinoma, head and neck squamous cell carcinoma, leukemia, lymphoma, myeloma, multiple myeloma, and solid tumors); Wilson's disease, spinocerebellar ataxia, prion disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis, amyloidosis, Alzheimer's disease, Alexander's disease, alcoholic liver disease, cystic fibrosis, Pick's disease, spinal muscular atrophy, or Lewy body dementia; rheumatoid arthritis, osteoarthritis; rheumatoid spondylitis; psoriasis; inflammatory bowel disease; chronic inflammatory lung disease, eczema, asthma, ischemia/reperfusion injury, ulcerative colitis, acute respiratory distress syndrome, psoriatic arthritis, infectious arthritis, progressive chronic arthritis, arthritis deformans, osteoarthritis, traumatic arthritis, gouty arthritis, Reiter's syndrome, polychondritis, acute synovitis and spondylitis, glomerulonephritis, hemolytic anemia, aplastic anemia, idiopathic thrombocytopenic purpura, neutropenia, ulcerative colitis, Crohn's disease, host-versus-graft disease, graft-versus-host disease, allograft rejection, chronic thyroiditis, Graves' disease, scleroderma, diabetes, active hepatitis, primary biliary cirrhosis, myasthenia gravis, multiple sclerosis (MS), systemic lupus erythematosus, atopic dermatitis, contact dermatitis, sunburn of the skin, chronic renal insufficiency, Stevens-Johnson syndrome, idiopathic steatorrhea, sarcoidosis, Guillain-Barre syndrome, uveitis, conjunctivitis, keratoconjunctivitis, otitis media, periodontal disease, pulmonary interstitial fibrosis, asthma, bronchitis, rhinitis, sinusitis, pneumoconiosis, pulmonary insufficiency syndrome, emphysema, pulmonary fibrosis, or silicosis 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 compound has ever been used to treat or prevent these diseases generally, 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. Applicants have not demonstrated nor have they alleged there is any correlation between the in vitro assays they disclose and clinical efficacy against these diseases generally. Case law is clear on this point. In an unpredictable art, in vitro assays may be used for enablement only if there is a well-established correlation between the assay and clinical efficacy.
d) The nature of the invention is clinical treatment of disease with inhibitors of HDAC6, which involves physiological activity.
e) The state of the clinical arts in the HDA6 inhibitor related diseases is extensive but lacks reports of success for treating or preventing these diseases.
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 all of the thousands of compounds as well as the hundreds 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 to inhibit HDA6.
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.
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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July 30, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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