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 .
According to a preliminary amendment filed on April 8, 2024, the applicants have canceled claims 1-4 and 11, amended claims 5-10 and 12-15 and furthermore, have added a new claim 16.
Claims 5-10 and 12-16 are pending in the application.
Claim Rejections - 35 USC § 112
4. 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 5-8, 10, 12-14 and 16 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. The following eight different factors (see Ex parte Foreman, 230 USPQ at 547; Wands, In re, 858.F. 2d 731, 8 USPQ 2d 1400, Fed. Cir. 1988) must be considered in order for the specification to be enabling for what is being claimed:
Quantity of experimentation necessary, the amount of direction or guidance provided, presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability and the breadth of claims. In the instant case, the specification is not enabling based on atleast four of the above mentioned eight different factors such as quantity of experimentation necessary, the amount of direction or guidance provided, presence of working examples, state of the prior art, unpredictability and the breadth of claims.
In regard to lack of enablement issue of instant claims 5-8, 10, 12-14 and 16 for hydrates and solvates of instant compounds of formula (II), there is no teaching or guidance present in the specification for preparing any specific hydrates (mono, di, tri or tetra), solvates. Preparation of specific hydrates or solvates of any compound is a very specialized field and involves their characterization using different techniques such as infrared spectrum, XRD powder diffraction etc. There is no teaching or guidance present in the specification regarding any specific solvents used for preparing specific hydrates or solvates and their characterization using any techniques such as XRD powder diffraction or infrared spectrum etc. There is not even a single example present for preparing any specific hydrate or solvate of instant compounds of formula (II). Healy (Adv. Drug Deliv. Rev.) teaches that differences in solid forms (hydrates, solvates or polymorphic forms) often leads to differences in thermodynamic parameters and physiochemical properties such as solubility, dissolution rate, stability and mechanical properties (see abstract and table 1 on page 28). Therefore, in absence of such teachings, guidance, presence of working examples and unpredictability, it would require undue experimentation to select specific hydrates or solvates of instant compounds with enhanced stability properties.
Regarding enablement issue of instant claims 12-14 and 16 for treating and preventing various diseases, the specification teaches inhibitory effect of instant compounds on transglutaminase 2 activity as shown in tables 1 and 2 (see pages 148-153 of specification). Based on these teachings, the instant compounds will have therapeutic utility for treating but not preventing (prophylaxis) of specific diseases where transglutaminase 2 inhibitors are well known in the art to have therapeutic utility. However, there is no teaching, suggestion either in the specification or prior art references provided showing well established utility of transglutaminase 2 inhibitors for treating every known autoimmune disease, inflammatory disease, vascular disease, liver disease, cancer, neurodegenerative disease, ocular disease and skin disease in the art. There are no working examples present showing efficacy of instant compounds in animal models of every known autoimmune disease, inflammatory disease, vascular disease, liver disease, cancer, neurodegenerative disease, ocular disease and skin disease in the art. There is lot of unpredictability in the art regarding transglutaminases (TGases) since Wodzinska (Mini-Rev. in Med. Chem., cited on applicant’s form 1449) teaches that it is not clear if elevated levels of TGases play a causative or protective role in several of these processes (see lines 7-8 of abstract). Therefore, in absence of such teachings, guidance, prior art, working examples and unpredictability, it would require undue experimentation to demonstrate efficacy of instant compounds in animal models of every known autoimmune disease, inflammatory disease, vascular disease, liver disease, cancer, neurodegenerative disease, ocular disease and skin disease in the art and hence their utility for treating these disease conditions.
In regard to preventing any disease condition, it is well known in the art that there are multiple mechanisms involved in the etiology of any disease condition in the art. Therefore, correcting only one of these several mechanisms such as inhibiting TGase2 activity in the instant case will not prevent (completely cure) any disease condition.
7. 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 6 and 8 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.
In claim 6, variables L2, R8, R10 and R11 are defined. However, these variables are not present in amended claim 6.
In claim 6, the value of variable L1 is not defined.
In claim 8, line 2, 6th and 7th structures are identical.
In claim 8, line 3, first and last structures are identical.
Allowable Subject Matter
Claims 9 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The instant compounds of formula (II) are allowable over the prior art since they are neither disclosed nor obvious over the prior art. In the prior art, Hils (WO 2018/122419 a1, cited on applicant’s form 1449) discloses compounds E16 and E17 (see page 112) which are closely related to instant compounds. However, the compounds of Hils differ from the instant compounds by having different value of instant variable R3. Furthermore, there is no teaching, guidance or motivation in the prior art to modify the compounds of Hils to prepare instant compounds.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621