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 paper filed on July 1, 2026, the applicants have elected group I and furthermore, elected compound 3 as specific species within group I for further prosecution. The applicants have also canceled claims 9, 12-53, 62, 65-106 and furthermore, have amended claims 8 and 61.
Claims 1-8, 10-11, 54-61, 63-64 and 107-128 are pending in the application. Claims 10 and 63 are withdrawn from further consideration as being directed to non-elected subject matter.
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 54-61, 64 and 107-128 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 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.
The specification mentions that the instant compounds are iRhom2/ADAM17 inhibitors. The specification also teaches inhibitory effect of instant compounds on TNF alpha and KitL2 (see table 4 on pages 81-82). However, there is no teaching or guidance present in the specification whether the instant compounds were actually found to be iRhom2/ADAM17 inhibitors. Furthermore, there is no teaching either in the specification or prior art showing well established utility of iRhom2/ADAM17 inhibitors in any disease condition including brain injury, Alzheimer’s disease, hemorrhagic stroke, hemophilic anthropathy, rheumatoid arthritis, cytokine storm and systemic lupus. There are no working examples present showing efficacy of instant compounds in animal models of any disease condition including brain injury, Alzheimer’s disease, hemorrhagic stroke, hemophilic anthropathy, rheumatoid arthritis, cytokine storm and systemic lupus. In absence of such teachings, guidance, prior art and working examples, it would require undue experimentation to demonstrate efficacy of instant compounds in animal models of every known disease condition in the art including brain injury, Alzheimer’s disease, hemorrhagic stroke, hemophilic anthropathy, rheumatoid arthritis, cytokine storm, systemic lupus etc. and hence their utility for treating these disease conditions.
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 54-61, 64 and 114-128 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 claims 54-61, 64 and 114-128, specific diseases associated with inhibition of iRhom2/ADAM17 are not defined.
Claim Rejections - 35 USC § 102
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.
Claims 1-6, 8, 54-59 and 61 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by He (Bioorganic & Medicinal Chem.).
He discloses Arylamides for treating tuberculosis. The compounds disclosed in table 1 (see page 6650) by He anticipate the instant claims when variables R1a and R1b represent phenyl groups in the instant compounds of formula (I). It is of note that iRhom2/ADAM17 will be inherently inhibited following administration of compounds of He for treating tuberculosis.
Claims 1-2, 4-6, 54-55, 57-59, 107 and 112 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Goehring (U.S. Patent 6,541,477 B2).
Goehring discloses compounds having P38-A kinase inhibitory activity for treating various diseases including rheumatoid arthritis, CNS injury and cytokine storm (see col. 60, line 56 to col. 61, line 5). The compounds disclosed in examples 1-5 (see col. 63-65) by Goehring anticipate the instant claims when variables R1a and R1b represent phenyl groups and variable X represents CH in the instant compounds of formula (I). It is of note that iRhom2/ADAM17 will be inherently inhibited following administration of compounds of Goehring for treating rheumatoid arthritis and brain (CNS) injury.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
14. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
15. Claims 114-128 are rejected under 35 U.S.C. 103 as being unpatentable over He (Bioorganic & Medicinal Chem.).
He discloses Arylamides for treating tuberculosis. The compounds disclosed in table 1 (see page 6650) by He meet all the limitations of the instant claims when variables R1a and R1b represent phenyl groups in the instant compounds of formula (I) except that He does not mention route of administration, specific doses of compounds and in combination with other drugs. However, it will be within the routine skill of an artesian to select route of administration and doses as well as to combine the compounds for treating tuberculosis with other drugs used for treating tuberculosis in order to have synergistic effect with reasonable expectation of success. It is of note that iRhom2/ADAM17 will be inherently inhibited following administration of compounds of He for treating tuberculosis.
16. Claims 114-128 are rejected under 35 U.S.C. 103 as being unpatentable over Goehring (U.S. Patent 6,541,477 B2).
Goehring discloses compounds having P38-A kinase inhibitory activity for treating various diseases including rheumatoid arthritis, CNS injury and cytokine storm (see col. 60, line 56 to col. 61, line 5). The compounds disclosed in examples 1-5 (see col. 63-65) by Goehring meet all the limitations of the instant claims when variables R1a and R1b represent phenyl groups and variable X represents CH in the instant compounds of formula (I) except that Goehring does not mention route of administration, specific doses of compounds and in combination with other drugs. However, it will be within the routine skill of an artesian to select route of administration and doses as well as to combine the compounds for treating rheumatoid arthritis and brain injury with other drugs used for treating rheumatoid arthritis and brain injury in order to have synergistic effect with reasonable expectation of success . It is of note that iRhom2/ADAM17 will be inherently inhibited following administration of compounds of Goehring for treating rheumatoid arthritis and brain (CNS) injury.
IMPROPER MARKUSH GROUP
17. Claims 1-8, 54-61 and 107-128 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
18. The Markush grouping of claims 1-8, 54-61 and 107-128 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: There is no common structural core present which is shared by all of the alternatives. In the instant compounds of formula (I), the specific values of variables R1a and R1b are critical for the common structural core of these compounds.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Allowable Subject Matter
19. Claim 11 is 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.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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