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 . Claims 1-20 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I and a species (a) (benzimidazole-type compounds, wherein X1 = X2 = X3 = X4 = C and X5 = N) in the reply filed on 02/11/2026 is acknowledged. The examiner searched the elected species and found a prior art and the search was stopped. If the examiner finds another prior art after applicant’s response to this Office Action, the next Office Action would be made Final.
The claims are drawn to multiple inventions for reasons set forth in the restriction requirement. The claims are examined only to the extent that they read on the elected invention. Cancellation of the non-elected subject matter is recommended in response to this Office Action. To expedite prosecution, the examiner recommends that applicants delete non-elected compounds AB24396, AB29502, AB29537, AB29573, AB29558, AB29567, and AB29568 from claims 10 and 14.
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 1-11, 14 and 18-20 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. In claim 1 or elsewhere in the claims it is recited a metabolite, N-oxide and prodrug of the compounds of formula I, but the specification is not enabled for such a scope.
A number of factors are relevant to whether undue experimentation would be required to practice the claimed invention, including “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
The instant claims recite “a N-oxide, a metabolite and a prodrug” wherein there is insufficient description in the specification regarding these types of ‘forms’ intended by the recitation. For example, compounds that increase the bioavailability of compounds are known as prodrugs. Note that prodrug definition uses an open-ended language. lt is also known that many examples of “prodrugs'' include acetates, etc., however, the definition of various substituent groups in the formula already include such groups, e.g., an alkanoyl group (which is -C(=O)-alkyl). Metabolite is defined in the specification however the definition is so broad that one could not envision what the compounds are. N-oxides cannot be determined due to the improper markush and not knowing how many or where the N atoms exist. Compounds with or without such functional groups are already included in the claimed compounds, and the specification does not provide sufficient disclosure regarding the preparation of all types of compounds embraced by the scope of the recitation of “prodrug, N-oxide and metabolite'' in the instant claims. In order to overcome this rejection, applicants have to delete “prodrug, N-oxide and metabolite'' from the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1-11, 14 and 18-20 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.
The Markush grouping of the elected species (a) (benzimidazole-type compounds, wherein X1 = X2 = X3 = X4 = C and X5 = N) compounds are 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: Claim 1 teaches various forms including a N-oxides, metabolites, and prodrugs, which are compounds that are not taught in the speification.
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.
Claim Rejections - 35 USC § 102
8. 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.
9. Claims 1-9 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CHEMCATS (Chemical Library Supplier: Enamine LLC) that was entered to STN database on 02 May 2017. Cited prior art compound (provided in applicant’s IDS) is the same as applicants when R1-R4 = H; L1 = -NH-CO-; ring A = pyrrole; L2 = -CH2-; and ring B = pyridine.
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Since said compound is the same as applicants, a 102(a)(1) rejection is proper. Note that there are prior art compounds submitted with the IDS. Applicants have to review their IDS and amend the claims to avoid prior art rejection.
10 and 14 are objected to as being drawn to multiple inventions, but may be allowable after further search if the non-elected species are deleted from claim 10. Applicants have to delete
Information Disclosure Statement
10. Applicant’s Information Disclosure Statement, filed on 01/21/2025, 09/27/2024, 07/18/2024, and 01/30/2024 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
Conclusion
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kahsay Habte/
Primary Examiner, Art Unit 1624
March 19, 2026