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 .
Current Status of 18 / 850984
Claims 1-13 and 18-23 are pending and examined in the present action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2025 July 30 was submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 19 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for treating breast cancer, inflammatory bowel disease, and systemic lupus erythematosus with a composition of claim 1 and non-enabling for treatment of the scope of disorders recited with a composition of claim 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth herein below:
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treating cancer or an automimmune disorder with an aqueous composition comprising a compound of formula I and a β-cyclodextrin . Thus, the claims taken together with the specification imply the specified aqueous composition can treat cancer or an autoimmune disease.
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The state of the prior art and (4) the predictability or unpredictability of the art:
ALDANA-MASANGKAY (Journal of Biomedicine and Biotechnology, 2011, article ID 875824, pages 1-10) describes the following ideas: HDAC6 inhibition is related to breast cancer; and more research is needed to understand what cancers are related to HDAC6 inhibition (page 8, section 12).
GHIBOUB (Journal of Personalized Medicine, 2021, 11 336, 1-24) describes the following ideas: HDAC6 inhibition is linked to inflammatory bowel disease and systemic lupus erythmatosus; and further research is needed to understand how HDAC6 inhibition is related to autoimmune disorders (page 7, section 3.2.2).
The relative skill of those in the art:
While the artisan generally would have an advanced degree in [area of claims], their high level of skill and knowledge is insufficient to overcome the lack of understanding as to how HDAC6 functions in the body or to overcome the art recognition that this disease is poorly understood and treatments have generally failed.
The amount of direction or guidance presented and the presence or absence of working examples:
The specification has provided guidance for treating breast cancer, inflammatory bowel disease, and systemic lupus erythematosus with a composition of claim 1.
The specification does not provide guidance for treatment of the scope of disorders recited with a composition of claim 1.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to diseases related to HDAC6 inhibition and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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 18 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 18 does not recite what disease or disorder is being treated.
Claim 19 recites the limitation that cancer or an autoimmune disease is being treated. There is insufficient antecedent basis for this limitation in the claim due to parent claim 18 not reciting what disease or disorder is being treated.
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.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MAA (Journal of Pharmaceutical Sciences, 2003, 92(2), 319-332) describes a dried pharmaceutical compositions (page 325, table 2). Claims 11-12 are product by process claims and the language “obtainable by drying the pharmaceutical formulation of claim 1” does not limit the dry pharmaceutical formulation.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ERFANI (Iranian Journal of Nuclear Medicine, 2015, 23(1), 15-20) describes a kit containing a freeze-dried radiopharmaceutical composition containing TRODAT-1. Claims 11-12 are product by process claims and the language “obtainable by drying the pharmaceutical formulation of claim 1” does not limit the dry pharmaceutical formulation.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HJELSTUEN (International Journal of Pharmaceutics, 1990, 190, 197-205) describes a kit containing a freeze-dried composition containing KNaT and water (pages 199-200, section 2.3). Claims 11-13 are product by process claims and the language “obtainable by drying the pharmaceutical formulation of claim 1” does not limit the dry pharmaceutical formulation.
Conclusion
Claims 1-20 and 20-23 are allowed. Claims 11-13 and 18-19 are not allowable.
The following is a statement of reasons for the indication of allowable subject matter: MORA (US 20120196885, published 2012 August 2) describes a compound (page 4, paragraph [0040]). This reference does not anticipate or render obvious a composition of claim 1 because it does not teach that this compound can form an aqueous composition with a cyclodextrin.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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