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 .
DETAILED ACTION
Claims 1-2, 4, 11, 18-21, 25, 29, 31-32, 38, 40, 42, 59-62 and 66 are pending in the present application file.
Election/Restrictions
Applicant’s election of Group I (claims 1, 2, 4, 11, 18-21, 25, 29, 31, 32, 38, 40, 42, and 59-61; directed to compounds of Formula (I), or a pharmaceutically acceptable salt thereof, and pharmaceutical compositions and kits thereof) and a species of present formula (I) without traverse in the reply filed March 11, 2026 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of present formula (I) appears free of the prior art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the species cited below under 35 U.S.C. 102, which are not allowable, as well as the species of present claims 59, which 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.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 1-2, 4, 11, 18-21, 25, 29, 31, 38, 40, 42 and 59-61 have been examined to the extent that they embrace and are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 32, 62 and 66 do not read on the presently searched and examined subject matter. Therefore, claims 32, 62 and 66 are withdrawn from consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed 01/30/2024 and 03/11/2026 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claims 42 and 59 are objected to because of the following informalities:
Claim 42 and 59 should include “or” between the last two formulas (e.g., “formula (I-o), or” and “28 or”) for the claims to be in proper Markush language format.
Appropriate correction is required.
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 1-2, 4, 11, 18, 21, 25, 31, 40, 42, 60-61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1704639-40-6 (which entered STN May 14, 2015).
CAS Registry No. 1704639-40-6 is drawn to [3-[5-(2-Fluorophenyl)-1,3,4-thiadiazol-2-yl]-1-piperidinyl]-2-quinoxalinylmethanone which has the following structure:
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CAS Registry No. 1704639-40-6 corresponds to a compound of formula (I) and formula (I-a) where R1 is halogen-substituted-phenyl, A1 is the first alternative provided (piperidine), L is -C(=O)-, A is the first alternative provided (pyrazine), R2 and R3 together with the atoms to which they are attached form a unsubstituted aryl (phenyl) and m is 0. See present claims 1-2, 4, 11, 18, 21, 25, 31, 40 and 42.
Regarding present claim 60, which is drawn to a pharmaceutical composition comprising a compound of the formula I and a pharmaceutically acceptable excipient, the CAS Registry entry includes predicted properties including mass and molar solubilities at varying pH values. MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would at once envisage a composition with the compound and water, which is a pharmaceutically acceptable excipient.
Regarding present claim 61 which is directed to a kit comprising a compound of formula (I) and instructions for administering the compound to a subject in need thereof, the additional limitation of instructions for administering the compound is directed to printed subject matter indicating how the composition should be used. MPEP 2111.05 states:
“To be given patentable weight, the printed matter and associated product must be in a functional relationship. A functional relationship can be found where the printed matter performs some function with respect to the product to which it is associated. See Lowry, 32 F.3d at 1584, 32 USPQ2d at 1035 (citing Gulack, 703 F.2d at 1386, 217 USPQ at 404).”
Applicant is further directed to MPEP 2112.01(III) which states:
“Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004)”.
In this situation, the printed subject matter only recites properties of the composition rather than dictating some functional relationship and thus not given patentable weight. The present claim is interpreted as requiring a kit comprising a compound of formula (I), which the CAS Registry entry teaches.
Claims 1-2, 4, 11, 19, 21, 25, 29, 31, 40, 42, 60-61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1704588-01-1 (which entered STN May 14, 2015).
CAS Registry No. 1704588-01-1 is drawn to [3-[5-(2-Fluorophenyl)-1,3,4-thiadiazol-2-yl]-1-piperidinyl]-1H-indol-6-ylmethanone which has the following structure:
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CAS Registry No. 1704588-01-1 corresponds to a compound of formula (I) and formula (I-a) where R1 is halogen-substituted-phenyl, A1 is the first alternative provided (piperidine), L is -C(=O)-, A is the second alternative provided (phenyl), R2 and R3 together with the atoms to which they are attached form a unsubstituted heteroaryl (pyrrole) and m is 0. See present claims 1-2, 4, 11, 19, 21, 25, 29, 31, 40 and 42.
Regarding present claim 60, which is drawn to a pharmaceutical composition comprising a compound of the formula I and a pharmaceutically acceptable excipient, the CAS Registry entry includes predicted properties including mass and molar solubilities at varying pH values. MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would at once envisage a composition with the compound and water, which is a pharmaceutically acceptable excipient.
Regarding present claim 61 which is directed to a kit comprising a compound of formula (I) and instructions for administering the compound to a subject in need thereof, the additional limitation of instructions for administering the compound is directed to printed subject matter indicating how the composition should be used. MPEP 2111.05 states:
“To be given patentable weight, the printed matter and associated product must be in a functional relationship. A functional relationship can be found where the printed matter performs some function with respect to the product to which it is associated. See Lowry, 32 F.3d at 1584, 32 USPQ2d at 1035 (citing Gulack, 703 F.2d at 1386, 217 USPQ at 404).”
Applicant is further directed to MPEP 2112.01(III) which states:
“Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004)”.
In this situation, the printed subject matter only recites properties of the composition rather than dictating some functional relationship and thus not given patentable weight. The present claim is interpreted as requiring a kit comprising a compound of formula (I), which the CAS Registry entry teaches.
Claims 1-2, 4, 11, 20, 38, 40, 42, 60-61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2310136-05-9 (which entered STN May 17, 2019).
CAS Registry No. 2310136-05-9 is drawn to 2-[1-(5-Phenyl-1,3,4-thiadiazol-2-yl)-3-piperidinyl]pyrimidine which has the following structure:
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CAS Registry No. 2310136-05-9 corresponds to a compound of formula (I) and formula (I-d) where R1 is phenyl, A1 is the first alternative provided (piperidine), L is a bond, A is the second alternative provided (pyrimidine), R2 and R3 are each hydrogen and m is 0. See present claims 1-2, 4, 11, 20, 38, 40 and 42.
Regarding present claim 60, which is drawn to a pharmaceutical composition comprising a compound of the formula I and a pharmaceutically acceptable excipient, the CAS Registry entry includes predicted properties including mass and molar solubilities at varying pH values. MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would at once envisage a composition with the compound and water, which is a pharmaceutically acceptable excipient.
Regarding present claim 61 which is directed to a kit comprising a compound of formula (I) and instructions for administering the compound to a subject in need thereof, the additional limitation of instructions for administering the compound is directed to printed subject matter indicating how the composition should be used. MPEP 2111.05 states:
“To be given patentable weight, the printed matter and associated product must be in a functional relationship. A functional relationship can be found where the printed matter performs some function with respect to the product to which it is associated. See Lowry, 32 F.3d at 1584, 32 USPQ2d at 1035 (citing Gulack, 703 F.2d at 1386, 217 USPQ at 404).”
Applicant is further directed to MPEP 2112.01(III) which states:
“Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004)”.
In this situation, the printed subject matter only recites properties of the composition rather than dictating some functional relationship and thus not given patentable weight. The present claim is interpreted as requiring a kit comprising a compound of formula (I), which the CAS Registry entry teaches.
Allowable Subject Matter
Claim 59 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.
Conclusion
Claims 32, 62 and 66 are withdrawn.
Claims 1-2, 4, 11, 18-21, 25, 29, 31, 38, 40, 42, 60-61 are rejected.
Claims 59 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626