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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Jan. 23, 2026 has been entered.
Claim Status
Claims 1-4, 6, 7 and 9-16 are currently pending and subject to examination.
Withdrawn Rejections – Overcome by Amendment or Argument
The rejection of claim 9 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn.
The Applicant argues that the attachment point of Ry can be on either side of the fused ring (Remarks, p. 7). These arguments were fully considered and are persuasive. Therefore, the rejection is withdrawn.
The rejection of claims 1, 3-4, 6-8 and 10-11 under 35 U.S.C. 102(a)(1) as being anticipated by Arnold et al. (US2007/0208053 A1) is withdrawn.
The rejection of claims 1-4, 7-8 and 10-11 under 35 U.S.C. 102(a)(1) as being anticipated by Eccles et al. (US 9,073,876 B2) is withdrawn.
The rejection of claims 1, 3-4, and 7-9 under 35 U.S.C. 102(a)(1) as being anticipated by “2-hydroxy-N-(1H-indazol-6-yl)benzamide” (PubChem CID 459471, published Aug. 1, 2005) (herein “PubChem”) is withdrawn.
The rejection of claims 1, 3-4, 6-8 and 10-16 under 35 U.S.C. 102(a)(1) as being anticipated by Arnold et al. (US2007/0208053 A1), citing to Albrecht et al. (WO2016138114A1) (of record) is withdrawn.
The rejection of claims 1-4, 7-8 and 10-15 under 35 U.S.C. 102(a)(1) as being anticipated by Eccles et al. (US 9,073,876 B2), citing to Albrecht is withdrawn.
The above rejections were overcome by amendment.
Claim Rejections – 35 USC § 102 – New Grounds of Rejection Necessitated by Amendment
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.”
Claim(s) 1, 2, 4, 7 and 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bjornson et al. (US 8,815,858 B2).
Response to Arguments
The Applicant argues that the compound of Bjornson is not a compound of formula I because the Ring P substituent is attached on the 5 membered ring (Remarks, p. 10). The Applicant has stated in response to the 112(d) rejection that even if the line connecting the substituent lies inside the 6 membered ring, that it is also allowed to be attached to the 5 membered ring (Remarks, p. 7). The examiner has considered this information and admits that the attachment point of Ry and Ring P can be on either fused ring. The Specification shows that both Ry and Ring P can be on the six-membered or five-membered side. For example, the specification shows that the compound of formula I includes compounds of formula I-b where Ring P is on both sides:
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Specification, p. 25.
Rejection
Claim 1 is directed towards a compound of formula I:
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Bjornson teaches a compound of formula I:
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Bjornson, Specification, col. 43.
As in formula I of claim 1, Lx is a covalent bond, P is phenyl, Rx is halogen, Ry is hydrogen, B and D are N, and A and E are C.
Therefore, claim 1 is anticipated.
Claims 2, 4, and 7 read on the compound above and are therefore also anticipated.
Claim 10 is directed towards a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier, adjuvant or vehicle.
Bjornson teaches a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier (Bjornson, Specification, col. 10, lines 27-31).
Therefore, claim 10 is anticipated.
Claim 11 is directed towards the composition of claim 10, further comprising an additional therapeutic agent. Bjornson teaches that the pharmaceutical composition can additionally comprise another therapeutic agent (Bjornson, Specification, col. 10, lines 37-47).
Therefore, claim 11 is anticipated.
Claim 12 is directed towards a method of inhibiting one or more of SMARCA2, SMARCA4, and PB1 protein in a patient comprising administering to said patient a compound of claim 1 or a pharmaceutical composition thereof.
Bjornson teaches that the compound of formula are used in a method for the treatment of patients suffering from HCV infection which comprises the administering to the patient an effective amount of the compound (Bjornson, Specification, col. 12, lines 41-46). While Bjornson does not teach that the method inhibits one or more of SMARCA2, SMARCA4, and PB1 protein, this is an inherent consequence of administering the compound to the patient. Bjornson teaches the compound and all affirmative method steps. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).” MPEP § 2112.I.
Therefore, claim 12 is anticipated.
Claim 13 is directed towards a method of treating one or more SMARCA2-mediated, SMARCA4, or PB1-mediated disorder, disease or condition in a patient comprising administering to said patient a compound according to claim 1. Claim 15 is directed towards the method of claim 13, wherein the one or more SMARCA2-mediated, SMARCA4-mediated or PB1-mediated disorder, disease or condition is selected from a cancer, a neurodegenerative disease, a viral disease, an autoimmune disease, an inflammatory disorder, a hereditary disorder, a hormone-related disease, a metabolic disorder, a condition associated with organ transplantation, an immunodeficiency disorder, a destructive bone disorder, a proliferative disorder, an infectious disease, a condition associated with cell death, thrombin-induced platelet aggregation, liver disease, a pathologic immune condition involving T cell activation, a cardiovascular disorder, and a CNS disorder.
Bjornson teaches that the compounds of formula I are used in a method for the treatment of patients suffering from viral disorder (HCV) which comprises the administering to the patient an effective amount of the compound (Bjornson, Specification, col. 12, lines 41-46).
Therefore, claims 13 and 15 are anticipated.
Claim 14 is directed towards the method of claim 13, further comprising administering an additional therapeutic agent. Bjornson teaches that the compound of the invention can be used in combination with an additional therapeutic agent and administered simultaneously or sequentially (Bjornson, Specification, col. 27, lines 34-65)
Therefore, claim 14 is anticipated.
Claim(s) 1, 4 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Savitha et al. (Molecular Diversity, Vol. 23, p. 697-707, Published Jan. 9, 2019).
Claim 1 is directed towards a compound of formula I:
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Savitha teaches compounds falling within the genus of formula I:
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Savitha, p. 701, Scheme 2.
As in formula I of claim 1, Lx is a covalent bond, P is phenyl, Rx is halogen, Ry is hydrogen, B is N and A, D and E are C.
Therefore, claim 1 is anticipated.
Claims 4 and 7 read on the compounds above and are therefore also anticipated.
Claim(s) 1, 4, 7, and 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garland et al. (US 7,297,792 B2).
Claim 1 is directed towards a compound of formula I:
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Garland teaches compounds falling within formula (I). For example, including but not limited to, compounds 157-160, 171-172, 174, 180-181, 189:
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Garland, Specification, col. 43-44.
As in formula I of claim 1, in the compounds above, Lx is a covalent bond, P is phenyl, A is C, B, D, and E are N, Ry is H and N(R)C(O)R, Rx is halogen and R is independently H, or an optionally substituted C1-6 aliphatic, phenyl, or 4-7 membered saturated or partially unsaturated heterocyclic having 1-2 heteroatoms selected from N, O and S.
Therefore, claim 1 is anticipated.
Claims 4 and 7 read on the compounds above and are therefore also anticipated.
Claim 10 is directed towards a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier, adjuvant or vehicle.
Garland teaches a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier (Garland, Specification, col. 26, lines 1-4).
Therefore, claim 10 is anticipated.
Claim 11 is directed towards the composition of claim 10, further comprising an additional therapeutic agent. Garland teaches that the composition may comprise an additional therapeutic agent:
The said combination comprises co-administration of a compound of formula (I), or a pharmaceutically acceptable derivative thereof, and an additional medicament agent… Co-administration includes administration of a pharmaceutical composition which contains both a compound of formula (I), or a pharmaceutically acceptable derivative thereof, and the additional medicament agent.
Garland, Specification, col. 26, lines 26-35.
Therefore, claim 11 is anticipated.
Claim 12 is directed towards a method of inhibiting one or more of SMARCA2, SMARCA4, and PB1 protein in a patient comprising administering to said patient a compound of claim 1 or a pharmaceutical composition thereof.
Garland teaches that the compounds of formula I are used in a method for the treatment of conditions such as diabetes, neurodegenerative diseases, inflammation, and immunodeficiency, which comprises the administration of a pharmaceutically effective, non-toxic, amount of the compound (Garland, Specification, col. 24-25). While Garland does not teach that the method inhibits one or more of SMARCA2, SMARCA4, and PB1 protein, this is an inherent consequence of administering the compound to the patient. Garland teaches the compound and all affirmative method steps. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).” MPEP § 2112.I.
Therefore, claim 12 is anticipated.
Claim 13 is directed towards a method of treating one or more SMARCA2-mediated, SMARCA4, or PB1-mediated disorder, disease or condition in a patient comprising administering to said patient a compound according to claim 1. Claim 15 is directed towards the method of claim 13, wherein the one or more SMARCA2-mediated, SMARCA4-mediated or PB1-mediated disorder, disease or condition is selected from a cancer, a neurodegenerative disease, a viral disease, an autoimmune disease, an inflammatory disorder, a hereditary disorder, a hormone-related disease, a metabolic disorder, a condition associated with organ transplantation, an immunodeficiency disorder, a destructive bone disorder, a proliferative disorder, an infectious disease, a condition associated with cell death, thrombin-induced platelet aggregation, liver disease, a pathologic immune condition involving T cell activation, a cardiovascular disorder, and a CNS disorder.
Garland teaches a method of treating the above disorders, diseases or conditions comprising administering an effective amount of a compound of claim 1:
The present invention also provides a method for the treatment of conditions associated with a need for inhibition of CSK-3 such as diabetes, conditions associated with diabetes, chronic neurodegenerative conditions including dementias such as Alzheimer's disease, Parkinson's disease, progressive supranuclear palsy, subacute sclerosing panencephalitic parkinsonism, postencephalitic parkinsonism, pugilistic encephalitis, guam parkinsonism-dementia complex, Pick's disease, corticobasal degeneration, frontotemporal dementia, Huntingdon's disease, AIDS associated dementia, amyotrophic lateral sclerosis, multiple sclerosis and neurotraumatic diseases such as acute stroke, mood disorders such as schizophrenia and bipolar disorders, promotion of functional recovery post stroke, cerebral bleeding (for example, due to solitary cerebral amyloid angiopathy), hair loss, obesity, atherosclerotic cardiovascular disease, hypertension, polycystic ovary syndrome, syndrome X, ischaemia, traumatic brain injury, cancer, leukopenia, Down's syndrome, Lewy body disease, inflammation, and immunodeficiency, which method comprises the administration of a pharmaceutically effective, non-toxic amount of a compound of formula (I) or a pharmaceutically acceptable derivative thereof,
Garland, Specification, col. 24-25.
Therefore, claims 13 and 15 are anticipated.
Claim 14 is directed towards the method of claim 13, further comprising administering an additional therapeutic agent. Garland teaches that the method can comprise administering an additional therapeutic agent:
The active compounds are usually administered as the sole medicament agent but they may be administered in combination with other medicament agents as dictated by the severity and type of disease being treated. For example in the treatment of diabetes, especially Type 2 diabetes, a compound of formula (I), or a pharmaceutically acceptable derivative thereof, may be used in combination with other medicament agents, especially antidiabetic agents such as insulin secretagogues, especially sulphonylureas, insulin sensitisers, especially glitazone insulin sensitisers (for example thiazolidinediones), or with biguanides or alpha glucosidase inhibitors or the compound of formula (I), or a pharmaceutically acceptable derivative thereof, may be administered in combination with insulin.
The said combination comprises co-administration of a compound of formula (I), or a pharmaceutically acceptable derivative thereof, and an additional medicament agent or the sequential administration of a compound of formula (I), or a pharmaceutically acceptable derivative thereof, and the additional medicament agent.
Co-administration includes administration of a pharmaceutical composition which contains both a compound of formula (I), or a pharmaceutically acceptable derivative thereof, and the additional medicament agent or the essentially simultaneous administration of separate pharmaceutical compositions of a compound of formula (I), or a pharmaceutically acceptable derivative thereof, and the additional medicament agent.
Garland, Specification, col. 26.
Therefore, claim 14 is anticipated.
Claim(s) 1, 4, 7, and 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eatherton et al. (WO2007017264 A2).
Claim 1 is directed towards a compound of formula I:
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Eartherton teaches compounds falling within the genus of formula I. For example,
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Eatherton, Specification, p. 57.
As in formula I of claim 1, in the compounds above, Lx is a covalent bond, P is phenyl, B is N, A, D, and E are C, Ry is H, R6 and C(O)R, Rx is halogen, R6 is hydrogen or C1 aliphatic and R is independently H, or an optionally substituted C1-6 aliphatic, phenyl, or 4-7 membered saturated or partially unsaturated heterocyclic having 1-2 heteroatoms selected from N, O and S.
Therefore, claim 1 is anticipated.
Claims 4 and 7 read on the compounds above and are therefore also anticipated.
Claim 10 is directed towards a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier, adjuvant or vehicle.
Eatherton teaches a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier (Eatherton, Specification, p. 19, lines 1-24).
Therefore, claim 10 is anticipated.
Claim 11 is directed towards the composition of claim 10, further comprising an additional therapeutic agent. Eatherton teaches that the pharmaceutical composition can additionally comprise a PDE4 inhibitor (Eatherton, Specification, p. 24, lines 29-30).
Therefore, claim 11 is anticipated.
Claim 12 is directed towards a method of inhibiting one or more of SMARCA2, SMARCA4, and PB1 protein in a patient comprising administering to said patient a compound of claim 1 or a pharmaceutical composition thereof.
Eatherton teaches that the compound of formula are used in a method for the treatment of patients suffering from an immune disorder, an inflammatory disorder, pain, rheumatoid arthritis, multiple sclerosis, osteoarthritis or osteoporosis which comprises the administering to the patient an effective amount of the compound (Eatherton, Specification, p. 19, lines 16-20). While Eatherton does not teach that the method inhibits one or more of SMARCA2, SMARCA4, and PB1 protein, this is an inherent consequence of administering the compound to the patient. Eatherton teaches the compound and all affirmative method steps. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).” MPEP § 2112.I.
Therefore, claim 12 is anticipated.
Claim 13 is directed towards a method of treating one or more SMARCA2-mediated, SMARCA4, or PB1-mediated disorder, disease or condition in a patient comprising administering to said patient a compound according to claim 1. Claim 15 is directed towards the method of claim 13, wherein the one or more SMARCA2-mediated, SMARCA4-mediated or PB1-mediated disorder, disease or condition is selected from a cancer, a neurodegenerative disease, a viral disease, an autoimmune disease, an inflammatory disorder, a hereditary disorder, a hormone-related disease, a metabolic disorder, a condition associated with organ transplantation, an immunodeficiency disorder, a destructive bone disorder, a proliferative disorder, an infectious disease, a condition associated with cell death, thrombin-induced platelet aggregation, liver disease, a pathologic immune condition involving T cell activation, a cardiovascular disorder, and a CNS disorder.
Eatherton teaches that the compounds of formula I are used in a method for the treatment of patients suffering from an immune disorder, an inflammatory disorder, pain, rheumatoid arthritis, multiple sclerosis, osteoarthritis or osteoporosis which comprises the administering to the patient an effective amount of the compound (Eatherton, Specification, p. 19, lines 16-20).
Therefore, claims 13 and 15 are anticipated.
Claim 14 is directed towards the method of claim 13, further comprising administering an additional therapeutic agent. Eatherton teaches that the method can comprise administering an additional therapeutic agent, including COX-2 inhibitors, anti-depressants, anti-Alzheimer’s agents, HT3 antagonists, and PDE4 inhibitors (Eatherton, Specification, p. 23-24).
Therefore, claim 14 is anticipated.
Claim(s) 1, 4, 7, and 10-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Do et al. (US 2013/0039906 A1).
Claim 1 is directed towards a compound of formula I:
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Do teaches compounds falling within the genus of claim 1. For example:
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Do, Specification, p. 14.
As in formula I of claim 1, in the compounds above, Lx is a covalent bond, P is phenyl or C6 heteroaryl with one N atom, B and E are N , A and D are C, Ry is H and R6, Rx is halogen, R6 is hydrogen or C1 aliphatic.
Therefore, claim 1 is anticipated.
Claims 4 and 7 read on the compounds above and are therefore also anticipated.
Claim 10 is directed towards a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier, adjuvant or vehicle.
Do teaches a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier (Do, Specification, paragraph [0012]).
Therefore, claim 10 is anticipated.
Claim 11 is directed towards the composition of claim 10, further comprising an additional therapeutic agent. Do teaches that the pharmaceutical composition can additionally comprise another chemotherapeutic agent (Do, Specification, paragraph [0086]).
Therefore, claim 11 is anticipated.
Claim 12 is directed towards a method of inhibiting one or more of SMARCA2, SMARCA4, and PB1 protein in a patient comprising administering to said patient a compound of claim 1 or a pharmaceutical composition thereof.
Do teaches that the compounds of formula are used in a method of inhibiting abnormal cell growth or treating a hyperproliferative disorder such as cancer in a mammal (e.g., human) comprising the administering to the mammal an effective amount of the compound (Do, Specification, paragraph [0088]). While Do does not teach that the method inhibits one or more of SMARCA2, SMARCA4, and PB1 protein, this is an inherent consequence of administering the compound to the patient. Do teaches the compound and all affirmative method steps. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).” MPEP § 2112.I.
Therefore, claim 12 is anticipated.
Claim 13 is directed towards a method of treating one or more SMARCA2-mediated, SMARCA4, or PB1-mediated disorder, disease or condition in a patient comprising administering to said patient a compound according to claim 1. Claim 15 is directed towards the method of claim 13, wherein the one or more SMARCA2-mediated, SMARCA4-mediated or PB1-mediated disorder, disease or condition is selected from a cancer, a neurodegenerative disease, a viral disease, an autoimmune disease, an inflammatory disorder, a hereditary disorder, a hormone-related disease, a metabolic disorder, a condition associated with organ transplantation, an immunodeficiency disorder, a destructive bone disorder, a proliferative disorder, an infectious disease, a condition associated with cell death, thrombin-induced platelet aggregation, liver disease, a pathologic immune condition involving T cell activation, a cardiovascular disorder, and a CNS disorder.
Do teaches that the compound of formula are used in a method for the treatment of mammals suffering a cancer which comprises the administering to the mammal an effective amount of the compound (Do, Specification, paragraph [0088]).
Therefore, claims 13 and 15 are anticipated.
Claim 14 is directed towards the method of claim 13, further comprising administering an additional therapeutic agent. Do teaches that the method can comprise administering an additional chemotherapeutic agent (Do, Specification, paragraph [0088]).
Therefore, claim 14 is anticipated.
Claim 16 is directed towards the method of claim 15, wherein the cancer is selected from lung cancer, breast cancer, pancreatic cancer, colorectal cancer, melanoma, leukemia, and malignant rhabdoid tumors.
Do teaches that “the present invention includes a method of treating multiple myeloma, lymphoma, acute myeloid leukemia, prostate cancer, breast cancer, hepatocellular carcinoma, pancreatic cancer, and/or colorectal cancer in a mammal (e.g., human), comprising administering to said mammal a therapeutically effective amount of a compound of Formula I” (Do, Specification, paragraph [0087]).
Therefore, claim 16 is anticipated.
Claim Objections - Dependent upon Rejected Base Claim
Claims 3, 6 and 9 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.
Related Art
A note is made of the following reference as related art: Chen et al. (US 2009/0149458 A1). The compounds of Chen differ from the instantly claimed genus by a single atom. For example, Chen teaches the compounds 3-(4-morpholin-4-yl-5H-pyrrolo[3,2-d]pyrimidin2-yl)phenol and 3-(4-morpholin-4-yl-7-piperidin-4-yl-5H-pyrrolo [3,2-d]pyrimidin-2-y1)phenol (Chen, Specification, paragraphs [0054] and [0074]) which have the following structures:
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(Drawn by Examiner in JChem)
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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/HEATHER DAHLIN/Examiner, Art Unit 1629