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 .
Claim Status
Claims 1, 2, 4, 6, 7 and 9-16 are currently pending and subject to examination.
Claim Rejections – Withdrawn – Overcome by Amendment
The rejection of claim(s) 1, 2, 4, 7 and 10-15 under 35 U.S.C. 102(a)(1) as being anticipated by Bjornson et al. (US 8,815,858 B2) is withdrawn.
The rejection of claim(s) 1, 4 and 7 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 (Molecular Diversity, Vol. 23, p. 697-707, Published Jan. 9, 2019) is withdrawn.
The rejection of claim(s) 1, 4, 7, and 10-15 under 35 U.S.C. 102(a)(1) as being anticipated by Garland et al. (US 7,297,792 B2) is withdrawn.
The rejection of claim(s) 1, 4, 7, and 10-15 under 35 U.S.C. 102(a)(1) as being anticipated by Eatherton et al. (WO2007017264 A2) is withdrawn.
The rejection of claim(s) 1, 4, 7, and 10-16 under 35 U.S.C. 102(a)(1) as being anticipated by Do et al. (US 2013/0039906 A1) is withdrawn.
The above rejections were overcome by Applicant’s amendments to the claims.
Claim Rejections – 35 USC § 112(a) (New Matter) – New Grounds Necessitated by Amendment
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, 2, 4, 6, 7 and 10-16 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 was amended to recite:
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This subgenus is not supported by the originally filed specification. The specification as filed does not support that at least one Rx is OH, nor does it support that the Rx group is only attached to the six membered ring and the Ry group is only attached to the five membered ring. The Specification describes multiple broad genera of compounds and diverse species of compounds and does not direct one of ordinary skill in the art to this particular subgenus of compounds.
In particular, the Specification describes Rx to be:
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Specification, para. [0049].
The Specification no where states that at least one Rx is OH.
The specification states that the point of attachment for the substituents can be on either ring:
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Id., para. [0050].
This directly contradicts the new definition of formula I as amended in claim 1.
Claims 2, 4, 6, 7 and 10-16 depend from claim 1 and also require the new matter definition of formula I and are therefore also rejected for containing new matter.
Claim Rejections – 35 USC § 103 – New Grounds of Rejection Necessitated by Amendment
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.”
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4, 7, and 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Do et al. (US 2013/0039906 A1) in view of McCurdy & Cohen (“Bioisosterism”, DrugDesignOrg, Feb. 2007, p. 1-138).
Claim 1 is directed towards a compound of formula I:
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.
Do teaches compounds largely similar to 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.
Claim 1 was amended to require that at least one Rx is OH. While the compounds of Do have Rx as halogen (F), one of ordinary skill in the art would have a reasonable expectation of success to substitute OH for F because it is commonly known in the art that F and OH are bioisosteres and as such replacing one for the other produces compounds with similar biological properties.
For example, see the teachings of McCurdy:
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McCurdy, p. 11-12.
Therefore, claim 1 was prima facie obvious at the time of filing.
Claims 4 and 7 read on the compounds above and are therefore also prima facie obvious for the reasons given in the rejection of claim 1.
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 was prima facie obvious at the time of filing.
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 was prima facie obvious at the time of filing.
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 was prima facie obvious at the time of filing.
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 were prima facie obvious at the time of filing.
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 was prima facie obvious at the time of filing.
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 was prima facie obvious at the time of filing.
Claim Objections - Dependent upon Rejected Base Claim
Claim 9 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
No claim is found to be allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on (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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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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