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 18/859,618
This Office Action is responsive to the amended claims of 10/24/2024, claims 1-10 and 12-19 are pending and have been examined on the merits.
Priority
The instant application is a national stage entry of PCT/EP2023/060886, filed 04/26/2023, which claims the benefit of priority to EP 22170229.3, filed 04/27/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/24/2024 is being considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: CRYSTAL FORM OF A PDE4 INHIBITOR.
Claim Objections
Claim 1 is objected to because of the following informalities: The figure of the compound of formula (I) is grainy and illegible. The figure should be replaced with a clear legible figure where all the substituents can clearly be identified such as the following:
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396
406
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. Appropriate correction is required.
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 12-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating inflammatory or obstructive respiratory disease, does not reasonably provide enablement for preventing these diseases. 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 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. While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of treating or preventing an inflammatory or obstructive respiratory disease comprising administering to a subject an effective amount of crystal Form 2 of instant claim 1. Thus, the claims taken together with the specification imply that the administration of an effective amount of crystal Form 2 is capable of preventing inflammatory or obstructive respiratory disease.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the prior art is that there are no established methods for identifying those patients who will acquire inflammatory or obstructive respiratory diseases before the diseases occur. This would require extensive, open-ended clinical research on health subjects. The claims are directed to a multitude of diseases including asthma and COPD which are two highly prevalent disorders, the prevention of which has eluded medical science. The prior art does teach that treatment of existing symptoms of such inflammatory and obstructive respiratory diseases can be successfully carried out (see Boswell-Smith et al. and Armani et al.).
(5) The relative skill of those in the art:
The artisan would have experience in the field of medicinal chemistry, pharmacology, pharmaceutical sciences, or a related field. The artisan would have experience in the development and use of small-molecule therapeutic agents for the treatment of inflammatory or obstructive respiratory diseases. The artisan would have knowledge of inflammatory and obstructive respiratory diseases and would have experience evaluating the pharmacological activity, formulation, dosing, and therapeutic use of compounds for treating such diseases.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided guidance for the preparation and physiochemical characterization of crystal Form 2 of the compounds of formula (I), including its crystalline properties and comparable solubility in simulated lung fluid (Examples 1-4, pgs. 15-18). The specification provides an in vivo pharmacokinetic study following intratracheal administration of crystal Form 2 to healthy rats, demonstrating it pulmonary residence time and providing information about its potential for lung accumulation and bioavailability (Example 5, pg. 18-19).
However, the specification does not provide any working examples of the claimed preventive procedures in man or animals.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to the lack of established methods for preventing inflammatory or obstructive respiratory diseases 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.
Claims 1-4 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.
Claims 1-3 each recite “[Cu Ka radiation (l=1.5406 Å)].” It is unclear whether the parenthetical phrase recites a required limitation of the claimed invention or merely describes a preferred embodiment. Accordingly, the claim fails to establish clear metes and bounds of the invention and is indefinite.
Claim 4 recites “(heating rate 10°C/min, N2 flow of 50ml/min).” It is unclear whether the parenthetical phrase recites a required limitation of the claimed invention or merely describes a preferred embodiment. Accordingly, the claim fails to establish clear metes and bounds of the invention and is indefinite.
Conclusion
Claims 1-4 and 12-15 are rejected.
Claims 5-10 and 16 are objected to for being dependent upon a rejected base claim.
The closest prior art of record is WO 2015/059050 A1 (found in IDS filed 10/24/2024). The ‘050 reference discloses crystal forms of compounds of formula (I)
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363
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. Although these compounds are the same as those of the instant application, it does not teach or suggest the specifically claimed XRPD pattern. Accordingly, the artisan would not have had a reasonable expectation that the compound disclosed by the reference would crystalize in a form exhibiting the XRPD pattern of the instant claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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