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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/089,965 and 63/151,468, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. A claim by claim analysis indicate a lack of support for the structure of ring A in claim 269, some of the compounds of Table C (claim 412) and table 1b of claim 427, thus these claims were given a priority date of 10/08/2021. All other claims were given a priority date of 10/09/2020.
Information Disclosure Statement
No information disclosure statement was provided.
Claim Rejections - 35 USC § 112
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 248, 249, 263, 412, 426, 427 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.
Claims 412, 426, 427 refer to Tables it is unclear these are from the specification. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)
Regarding claims 426 and 427, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 248, 249, 263 , the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 51, 60, 76, 183, 184, 255, 256, 257 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by SCHULZE (SCHULZE et al., WO-2020161257-A1, 13.08.2020).
The reference SCHULZE teaches the following compound (Example 13 page 200), wherein A=Rg=C6 aryl substituted with 1 Rc=halo, R7=H, R4=H, R1c=H, R2a= R2b= R3a= R3b=H, C=
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=Xa=H, Xb=H and X1, X1=(X2)m-L1-R5, X2=N(Rn)C(=O), m=1, Rn=H, L1=C1 alkylene, R5=Rg, Rg=C6 aryl substituted with 1 Rc=halo. This anticipates claims 1, 51, 60, 76, 183, 184, 255, 256, 257.
As for the proviso language (instant claims page 6-7) as long as the prior art is not one of the last three compounds (final bullet point) it has met the condition that one of the following applies.
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Claim(s) 1, 192, 193, 194, 195, 196, 203, 248, 249 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by SCHULZE (SCHULZE et al., US2023365554A1, 2020-07-29).
The reference SCHULZE teaches the following compound (Example 14 page 63), wherein A=Rg=C6 aryl, R7=H, R4=H, R1c=Me, R2a= R2b= R3b=H, R3a=Rb=alkyl, C=
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=Xa=H, Xb=H and X1, X1=(X2)m-L1-R5, X2=N(Rn)C(=O), m=1, Rn=H, L1=C1 alkylene, R5=Rg, Rg=C6 aryl substituted with 1 Rc=halo. This anticipates claims 1, 192, 193, 194, 195, 196.
As for the proviso language (instant claims page 6-7) as long as the prior art is not one of the last three compounds (final bullet point) it has met the condition that one of the following applies.
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The reference SCHULZE teaches the following compound (Example 1 page 57), wherein A=Rg=C6 aryl, R7=H, R4=H, R1c=Me, R2a= R2b= R3b=H, R3a=Rb=alkyl, C=
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=Xa=H, Xb=H and X1, X1=(X2)m-L1-R5, X2=N(Rn)C(=O), m=1, Rn=H, L1=C1 alkylene, R5=Rg, Rg=C6 aryl substituted with 1 Rc=halo. This anticipates claims 1, 248, 249.
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The reference SCHULZE teaches the following compound (Example 18 page 64), wherein A=Rg=C6 aryl, R7=H, R4=H, R1c=Me, R2a= R2b= R3b=H, R3a=(Lg(alkylene))g-Rg (cycloalkyl), C=
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=Xa=H, Xb=H and X1, X1=(X2)m-L1-R5, X2=N(Rn)C(=O), m=1, Rn=H, L1=C1 alkylene, R5=Rg, Rg=C6 aryl substituted with 1 Rc=halo. This anticipates claims 1, and 203.
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Claim(s) 1, 51, 60, 76, 183, 185, 186, 413, 414 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by SCHULZE (SCHULZE et al., WO-2020161257-A1, 13.08.2020).
The reference SCHULZE teaches the following compound (Example 22 page 209), wherein A=Rg=C6 aryl, R7=H, R4=H, R1c=H, R3a= R3b=H, R2a= R2b= Rb=C1 alkyl, C=
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, Xa=H, Xb=H and X1, X1=(X2)m-L1-R5, X2=N(Rn)C(=O), m=1, Rn=H, L1=C1 alkylene, R5=Rg, Rg=C6 aryl substituted with 1 Rc=halo. This anticipates claims 1, 51, 60, 76, 183, 185, 186.
As for the proviso language (instant claims page 6-7) as long as the prior art is not one of the last three compounds (final bullet point) it has met the condition that one of the following applies.
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The reference SCHULZE teaches (reference claim 14):
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This anticipates claims 413.
The reference SCHULZE teaches “The present invention relates to a method for using the compounds of the present invention and compositions thereof, to treat mammalian hyper-proliferative disorders. Compounds can be utilized to inhibit, block, reduce, decrease, etc., cell proliferation and/or cell division, and/or produce cell death e.g. apoptosis. This method comprises administering to a mammal in need thereof, including a human, an amount of a compound of this invention, or a pharmaceutically acceptable salt, isomer, polymorph, metabolite, hydrate, solvate or ester thereof ; etc. which is effective to treat the disorder. Hyper-proliferative disorders include but are not limited, e.g., psoriasis, keloids, and other hyperplasias affecting the skin, benign prostate hyperplasia (BPH), solid tumours, such as cancers of the breast, respiratory tract, brain, reproductive organs, digestive tract, urinary tract, eye, liver, skin, head and neck, thyroid, parathyroid and their distant metastases. Those disorders also include lymphomas, sarcomas, and leukaemias”(page 56-57). This anticipates claim 414.
Claim(s) 1, 51, 60, 76, 183, 185, 186, 263 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by SCHULZE (SCHULZE et al., WO-2020161257-A1, 13.08.2020).
The reference SCHULZE teaches the following compound (Example 112 page 295), wherein A=Rg=C6 aryl substituted with 2 Rc=halo, R7=H, R4=H, R1c=H, R3a= R3b=H, R2a= R2b= Rb=C1 alkyl, C=
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, Xa=H, Xb=H and X1, X1=(X2)m-L1-R5, X2=N(Rn)C(=O), m=1, Rn=H, L1=C1 alkylene, R5=Rg, Rg=C6 aryl substituted with 1 Rc=halo. This anticipates claims 1, 51, 60, 76, 183, 185, 186, 263.
As for the proviso language (instant claims page 6-7) as long as the prior art is not one of the last three compounds (final bullet point) it has met the condition that one of the following applies.
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Claim(s) 1, 51, 60, 76, 183, 184, 255, 256, 257, 270 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by SCHULZE (SCHULZE et al., WO-2020161257-A1, 13.08.2020).
The reference SCHULZE teaches the following compound (Example 12 page 199), wherein A=Rg=C6 heteroaryl, R7=H, R4=H, R1c=Rb=C1 alkyl, R2a= R2b= R3a= R3b=H, C=
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, Xa=H, Xb=H and X1, X1=(X2)m-L1-R5, X2=N(Rn)C(=O), m=1, Rn=H, L1=C1 alkylene, R5=Rg, Rg=C6 aryl substituted with 1 Rc=halo. This anticipates claims 1, 51, 60, 76, 183, 184, 255, 256, 257, 270.
As for the proviso language (instant claims page 6-7) as long as the prior art is not one of the last three compounds (final bullet point) it has met the condition that one of the following applies.
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Claim(s) 1, 269, 413, 414, 415, 416, 417, 426, 427 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SIEGEL (SIEGEL et al., WO2019081486A1, 02.05.2019).
The reference SIEGEL teaches the following compound (Page 257 example 66), wherein A=Rg=C6 aryl substituted with 2 Rc=halo, C1 alkoxy R7=H, R4=H, R1c=H, R2a= R2b= R3a= R3b=H, C=heteroaryl including 5 ring atoms, wherein 1 is N and substituted with X1, X1=(X2)m-L1-R5, X2=O, m=1, Rn=H, L1=C1 alkylene, R5=Rg, Rg=heterocyclyl. This anticipates claims 1 and 269.
As for the proviso language (instant claims page 6-7) as long as the prior art is not one of the last three compounds (final bullet point) it has met the condition that one of the following applies.
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The reference SIEGEL teaches (reference claim 10):
“A pharmaceutically acceptable carrier or auxiliary is preferably a carrier that is non-toxic and innocuous to a patient at concentrations consistent with effective activity of the active ingredient so that any side effects ascribable to the carrier do not vitiate the beneficial effects of the active ingredient. Carriers and auxiliaries are all kinds of additives assisting to the composition to be suitable for administration.”(page 48.
This anticipates claim 413.
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The reference SIEGEL teaches (reference claims 8, 19):
This anticipates claims 414, 415, 416, 417.
The reference SIEGEL teaches (reference claim 30):
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This anticipates claims 415, 416, 417.
The reference SIEGEL teaches (reference claims 32, 33):
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This anticipates claims 426, 427.
Claim(s) 1, 2, 4, 5, 273 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN (STN., Registry CAS 1258961-04-4, 01/11/2011).
As for the proviso language (instant claims page 6-7) as long as the prior art is not one of the last three compounds (final bullet point) it has met the condition that one of the following applies.
The reference STN teaches the following compound (Page 257 example 66), wherein A=Rg=C6 aryl substituted with 1 Rc=OH, R7=H, R4=Rd= methyl, R1c=H, R2a= R2b= R3a= R3b=H, C=heteroaryl including 6 ring atoms wherein 2 are N further substituted with 1 Rc=NReRf, Re=Rf=H. This anticipates claims 1, 2, 4, 5, 273. This anticipates claims 1, 2, 4, 5, 273.
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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, 2, 4, 5, 273, 192, 193, 194, 195, 196, 248, 249 is/are rejected under 35 U.S.C. 103 as being unpatentable over STN (STN., Registry CAS 1258961-04-4, 01/11/2011).
The reference STN teaches the following compound (Page 257 example 66), wherein A=Rg=C6 aryl substituted with 1 Rc=OH, R7=H, R4=Rd= methyl, R1c=H, R2a= R2b= R3a= R3b=H, C=heteroaryl including 6 ring atoms wherein 2 are N further substituted with 1 Rc=NReRf, Re=Rf=H. This anticipates claims 1, 2, 4, 5, 273. This anticipates claims 1, 2, 4, 5, 273.
As for the proviso language (instant claims page 6-7) as long as the prior art is not one of the last three compounds (final bullet point) it has met the condition that one of the following applies.
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The reference STN does not teach the specific substituted structures of claims 192, 193, 194, 195, 196, 248, 249.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified the reference STN to substitute a methyl group for a H as claimed by instant claims 192, 193, 194, 195, 196, 248, 249 because it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963). Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the H group for a Me. 2144.08(II)(A)(4)(c).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 51, 183, 184, 185, 186, 192, 193, 194, 195, 196, 199, 201, 202, 203, 215, 221, 232, 248, 249, 255, 256, 257, 263, 269, 270, 272, 413, 414, 415, 416, 417, 425, 426, 427 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 28, 37, 44, 50, 68, 72, 75, 81, 87-89, 94, 101, 106, 113, 121-122, 125, 139, 141, 144, 147-148, 292-297, and 306-308. of copending Application No. 18/027,316 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because :
The application ‘316 claims:
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Wherein A=Rg=C6 aryl substituted with 2 Rc=halo, C1 alkoxy, R7=H, R4=H, R1c=H, R2a= R2b= R3a= R3b=H, C=heteroaryl including 5 ring atoms, wherein 1 is N and substituted with X1, X1=(X2)m-L1-R5, X2=O, m=1, L1=C1 alkylene, R5=Rg, Rg=heteraryl.
As for the proviso language (instant claims page 6-7) as long as the prior art is not one of the last three compounds (final bullet point) it has met the condition that one of the following applies.
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This anticipates claims 1, 51, 183, 184, 185, 186, 192, 193, 194, 195, 196, 199, 201, 202, 203, 215, 221, 232, 248, 249, 255, 256, 257, 263, 269, 270, 272, 413, 414, 415, 416, 417, 425, 426, 427.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 8, 16, 78, 276, 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.
Conclusion
Claims 1, 2, 4, 5, 51, 60, 76, 183-186, 192-196, 199, 201-203, 215, 221, 232, 248, 249, 255, 256, 257, 263, 269, 270, 272, 273, 412, 413, 414, 415, 416, 417, 425, 426, 427 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR SALAMATIAN whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.S./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627