DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1, 5-7, 9, 12, 16-20, 22, 24, 25, 27-30, 32, 34, 36-38 and 40-42 are pending in the instant invention. According to the Amendments to the Claims, filed May 20, 2024, claims 5-7, 9, 12, 16-20, 22, 24, 25, 27-30, 32, 34, 36, 38 and 40-42 were amended and claims 2-4, 8, 10, 11, 13-15, 21, 23, 26, 31, 33, 35 and 39 were cancelled.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/CN2022/131173, filed November 10, 2022, which claims priority under 35 U.S.C. § 119(a-d) to: a) International Application No. PCT/CN2022/110609, filed August 5, 2022; b) International Application No. PCT/CN2022/105531, filed July 13, 2022; and c) International Application No. PCT/CN2022/093590, filed May 18, 2022; and under 35 U.S.C. § 119(e) to US Provisional Application Nos.: d) 63/311,456, filed February 18, 2022; e) 63/298,647, filed January 12, 2022; f) 63/291,571, filed December 20, 2021; and g) 63/281,671, filed November 20, 2021.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on June 29, 2026, is acknowledged: a) Group I - claims 1, 5-7, 9, 12, 16-20, 22, 24, 25, 27-30, 32, 34, 36 and 38; and b) substituted pyrrolo[2,3-b]pyridine of formula (I) - p. 98, Table 1, compound 242, shown to the right below, and hereafter referred to as 2-((3-fluoro-6-methoxy-1H-pyrrolo[2,3-b]pyridin-5-yl)oxy)-N-((6-(((1r,4r)-4-hydroxy-4-methyl-cyclohexyl)methyl)amino)-5-nitropyridin-3-yl)sulfonyl)-4-(2-((R)-2-(2-isopropylphenyl)-4-((2-methoxypyridin-4-yl)methyl)piperazin-1-yl)-7-azaspiro[3.5]nonan-7-yl)benzamide, where m = 0; m1 = 1; m2 = 1; W = -NR4-, wherein R4 = -CH2-pyridin-4-yl, substituted at C-2 by RX4, where RX4 = -(CRc1Rd1)tORb1, wherein t = 0 and Rb1 = -CH3; R6 = -phenyl, substituted at C-2 by RX6, wherein RX6 = -CH(CH3)2; Z = N; n1 = 0; n2 = 0; Y = CH; p1 = 1; p2 = 1; X = N; R2 = -ORA2, wherein RA2 = -CH3; R3 = -F; L = -(CRC0RD0)u-NRA0-(CRC0RD0)t-, wherein u = 0, RA0 = -H, t = 1, RC0 = -H and RD0 = -H; and R1 = -cyclohexyl, substituted at C-4 by RX1, wherein RX1 = -CH3 and at C-4 by RX1, wherein RX1 = -(CRc1Rd1)tORb1, where t = 0 and Rb1 = -H. Claims 1, 5-7, 9, 12, 16-20, 22, 24, 25, 29, 30, 32, 34, 36 and 38 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Likewise, the inventor or joint inventor should further note that the elected species, shown to the right above, was found to be free of the prior art. Thus, the examiner has expanded the forthcoming prosecution to include all claims relevant to the genus of Group I, for a first Office action and prosecution on the merits.
Moreover, the inventor or joint inventor should further note that claims 37 and 40-42 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 1, 5-7, 9, 12, 16-20, 22, 24, 25, 27-30, 32, 34, 36 and 38 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying the substituted pyrrolo[2,3-b]pyridines of the formula (I).
The following title is suggested: SUBSTITUTED PYRROLO[2,3-b]PYRIDINES AS BCL-2 INHIBITORS.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, 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 reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of formula (I) into the abstract, to overcome this objection.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claim 12 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 12 recites the broad limitation, H, F, Cl, Br, CH3, CH2CH3, and CF3, with respect to R3, and the claim also recites H and F, with respect to R3, which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, to overcome this rejection.
Claim 25 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 25 recites the broad limitation, halogen, C1-10 alkyl, etc., with respect to RX6, and the claim also recites halogen, CH3, CH2CH3, etc., with respect to RX6, which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, to overcome this rejection.
Claim 28 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 28 recites the broad limitation, the moiety… in Formula (I) is…, with respect to W, and the claim also recites preferably… the moiety… in Formula (I) is…, with respect to W, which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, to overcome this rejection.
Claim 30 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 30 recites the limitation, A compound of claim 1… wherein the moiety… in Formula (I) or Formula (II) is…, in lines 1-2 of the claim. There is insufficient antecedent basis, in claim 1, for this limitation, with respect to the substituted pyrrolo[2,3-b]pyridines of the formula (I). According to claim 1, Formula (II) is not recited, with respect to the substituted pyrrolo[2,3-b]pyridines of the formula (I).
The examiner suggests amending the claim, to overcome this section of the rejection.
Similarly, the inventor or joint inventor should further note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Likewise, the inventor or joint inventor should further note that claim 30 recites the broad limitation, wherein the moiety… in Formula (I)… is…, and the claim also recites preferably the moiety… in Formula (I)… is…, which is the narrower statement of the limitation.
Next, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, to overcome this section of the rejection.
Claim 36 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Similarly, the inventor or joint inventor should further note that claim 36 recites the broad limitation, methyl, ethyl, etc., with respect to RX1, and the claim also recites preferably… methyl, ethyl, etc., with respect to RX1, which is the narrower statement of the limitation.
Likewise, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
The examiner suggests amending the claim, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 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, 5, 7, 9, 12, 16, 24, 25, 28, 30, 32, 34, 36 and 38 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Zhang, et al. in WO 21/223736.
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The inventor or joint inventor should note that the instant invention recites a substituted pyrrolo[2,3-b]pyridine of the formula (I), shown to the left, where m = 0; m1 = 0; m2 = 1; W = -CR4R4’-, wherein R4 = -H and R4’ = -H; R6 = -phenyl, substituted at C-2 by RX6, wherein RX6 = -C1-10 alkyl; Z = N; n1 = 0; n2 = 0; Y = CH; p1 = 1; p2 = 1; X = N; R2 = -H; R3 = -H; L = -(CRC0RD0)u-NRA0-(CRC0RD0)t-, wherein u = 0, RA0 = -H, t = 1, RC0 = -H and RD0 = -H; and R1 = -cyclohexyl, substituted at C-4 by RX1, wherein RX1 = -C1-10 alkyl and at C-4 by RX1, wherein RX1 = -(CRc1Rd1)tORb1, where t = 0 and Rb1 = -H, respectively, and/or a pharmaceutical composition thereof, as a B-cell lymphoma-2 (Bcl-2) inhibitor.
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Similarly, the inventor or joint inventor should further note that Zhang, et al. (WO 21/223736), as provided in the file and cited on the IDS and International Search Report (ISR), teaches a substituted pyrrolo[2,3-b]pyridine of the formula (I), shown to the right, where m = 0; m1 = 0; m2 = 1; W = -CR4R4’-, wherein R4 = -H and R4’ = -H; R6 = -phenyl, substituted at C-2 by RX6, wherein RX6 = -CH(CH3)2; Z = N; n1 = 0; n2 = 0; Y = CH; p1 = 1; p2 = 1; X = N; R2 = -H; R3 = -H; L = -(CRC0RD0)u-NRA0-(CRC0RD0)t-, wherein u = 0, RA0 = -H, t = 1, RC0 = -H and RD0 = -H; and R1 = -cyclohexyl, substituted at C-4 by RX1, wherein RX1 = -CH3 and at C-4 by RX1, wherein RX1 = -(CRc1Rd1)tORb1, where t = 0 and Rb1 = -H, respectively, and/or a pharmaceutical composition thereof, as a B-cell lymphoma-2 (Bcl-2) inhibitor {p. 55, row 4, column 3; and pharmaceutical compositions - p. 8, ¶[12]}.
Likewise, the inventor or joint inventor should further note that, although not explicitly discussed herein, this reference contains additional species that may anticipate the instantly recited substituted pyrrolo[2,3-b]pyridines of the formula (I). Consequently, any amendments to the claims and/or arguments formulated to overcome rejections rendered under 35 U.S.C. § 102 should address this reference as a whole and should not be limited to the species discussed or disclosed explicitly herein.
Moreover, the inventor or joint inventor should further note that in the event the determination of the status of the invention as subject to AIA 35 U.S.C. § 102 (or as subject to pre-AIA 35 U.S.C. § 102) is incorrect, any correction of the statutory basis for the instant 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.
Claim Rejections - Obviousness-type 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 obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined invention claim is not patentably distinct from the reference claims because the examined invention claim is either anticipated by, or would have been obvious over, the reference claims. {See 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969)}.
Consequently, claims 1, 5-7, 9, 12, 16-20, 22, 24, 25, 27-30, 32, 34, 36 and 38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over at least claims 1, 3, 5, 9, 12, 13, 21, 24, 25, 53, 65, 68, 69, 73, 77, 84 and 85 of copending US Application No. 17/998,234. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 in the copending invention recites substituted pyrrolo[2,3-b]pyridines of the formula (I), where m = 0; m1 = 1; m2 = 1; W = -NR12-, wherein R12 = -C1-4 alkyl-heteroaryl; R3 = -phenyl; A = N; n = 0; n1 = 0; n2 = 0; B = CH; p = 0; p1 = 1; p2 = 1; Z = N; q = 0; Y1 = CH; Y2 = CH; Y3 = CH; L2 = -O-; R2 = -heteroaryl; X1 = N; X2 = CR9, wherein R9 = -H; X3 = CR10, wherein R10 = -H; L1 = -CH2-; and R1 = -C3-10 cycloalkyl, respectively, which provide overlapping subject matter with respect to the instantly recited substituted pyrrolo-[2,3-b]pyridines of the formula (I), where m = 0; m1 = 1; m2 = 1; W = -NR4-, wherein R4 = -C1-4 alkyl-heteroaryl; R6 = -aryl; Z = N; n1 = 0; n2 = 0; Y = CH; p1 = 1; p2 = 1; X = N; R2 = -H; R3 = -H; L = -(CRC0RD0)u-, wherein u = 1, RC0 = -H and RD0 = -H; and R1 = -C3-10 cycloalkyl, respectively.
The inventor or joint inventor should note that this is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Similarly, the inventor or joint inventor should further note that a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 37 CFR 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground, provided the conflicting invention or patent either is shown to be commonly owned with this invention, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Likewise, the inventor or joint inventor should further note that the USPTO internet Web site contains terminal disclaimer forms which may be used, and the inventor or joint inventor is encouraged to visit http://www.uspto.gov/forms/, where (i) the filing date of the invention will determine what form should be used, and (ii) a web-based eTerminal Disclaimer may be filled out completely online using web-screens, respectively.
Moreover, the inventor or joint inventor should further note that an eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission.
Finally, for more information about eTerminal Disclaimers, the inventor or joint inventor should refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
Prosecution Insights