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
The present application claims priority to the applications: 63/202,693, 63/363,133, and PCT/US2022/073060, with the effective filing dates of 21 June 2021, 18 April 2022, and 21 June 2022.
Claim Status
This Office Action is in response to Applicant’s Response to Restriction Requirement filed, 14 April 2026.
Applicant’s election without traverse of Group I (claims 1, 4-9, 12-14, and 16-23) and Compound ADS-1 (
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) in the reply filed on 14 April 2026 is acknowledged.
Claims 25-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group (Group II: claims 25-26), there being no allowable generic or linking claim.
Claims 6-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claim 6 specifies each of Rb, R, Rd, and Re is independently hydrogen, halogen, -CN, -NO2, -CHF2, -CF3, -OR, -SR, -N(R)2, -S(O)2R, -S(O)2N(R)2, -S(O)R, -S(O)N(R)2, - C(O)R, -C(O)OR, -C(O)N(R)2, -C(O)N(R)OR, -OC(O)R, -OC(O)N(R)2, -N(R)C(O)OR, -N(R)C(O)R, -N(R)C(O)N(R)2, -N(R)C(NR)N(R)2, -N(R)N(R)2, -N(R)S(O)2N(R)2, -N(R)S(O)2R, -N=S(O)(R)2, - S(NR)(O)R, -N(R)S(O)R, -N(R)CN, -P(O)(R)N(R)2, -P(O)(R)OR, or -P(O)(R)2; or each of Rb, R, Rd, and Re is independently an optionally substituted group selected from C1-6 aliphatic; phenyl; a 3-7 membered saturated or partially unsaturated monocyclic carbocyclic ring; a 3-7 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently selected from nitrogen, oxygen, phosphorous, silicon and sulfur; and a 5-6 membered monocyclic heteroaryl ring having 1--4 heteroatoms independently selected from nitrogen, oxygen, and sulfur; wherein Rc and Re are absent if not allowed by valence, which does not read on the elected species (the elected species requires Rb and Rd together with the atoms to which each are attached forms
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). Claim 7 specifies that Rb and Rc, together with Z1, form a group selected from a 3-7 membered saturated or partially unsaturated monocyclic carbocyclic ring; a 5-6 membered monocyclic aryl ring; a 3-7 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently selected from nitrogen, oxygen, phosphorous, silicon and sulfur; and a 5-6 membered monocyclic heteroaryl ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, and sulfur, which does not read on the elected species. Claim 8 specifies that Rd and Re, together with Z2, form a group selected from a 3-7 membered saturated or partially unsaturated monocyclic carbocyclic ring; a 5-6 membered monocyclic aryl ring; a 3-7 membered saturated or partially unsaturated monocyclic heterocyclic ring having 1-2 heteroatoms independently selected from nitrogen, oxygen, phosphorous, silicon and sulfur; and a 5-6 membered monocyclic heteroaryl ring having 1-4 heteroatoms independently selected from nitrogen, oxygen, and sulfur, which does not read on the elected species. Claim 9 specifies that the group,
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, is
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, which does not read on the elected species.
Thus, claims 1, 4-5, 12-14, and 16-23 are under consideration in the instant office action.
Information Disclosure Statement
The Information Disclosure Statements filed 11 June 2025, 17 July 2025, 21 October 2025, and 21 January 2026 and the reference cited therein have been considered, unless indicated otherwise.
Claim Objections
1. Claims 20-22 are objected to because of the following informalities: lack of comma and/or conjunction to separate the options. Claim 20 recites Formula II-a to II-j, but claim 20 does not separate the formulas via comma nor specify a conjunction (i.e. “and” or “or). Similarly, claim 21 recites Formula II-b-1 to II-b-12, and claim 22 recites the compounds of Table 1. However, claims 21 and 22 do not separate the structures via comma nor specify a conjunction.
Priority
The elected species,
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, does not appear in the disclosure of 63/202,693 and is thus denied the benefit of the 21 June 2021 effective filing date.
The elected species is present in the provisional application, 63/363,133, and is afforded the 18 April 2022 effective filing date. Accordingly, claims 1, 4-5, 12-14, and 16-23 have the benefit of the 18 April 2022 effective filing date.
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.
(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.
2. Claims 1, 4-5, 12-14, 16-17, 19, and 23* are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Barsanti (WO 2019/148005, published 1 Aug 2019, see IDS filed 11 June 2025).
*While Applicant elected a compound of Formula (I) (
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), Barsanti applies to the broader genus, and thus the rejection over the broader genus is made in favor of compact prosecution. However, the Examiner notes that the full genus was not searched.
Barsanti teaches Cbl-B inhibitors and specifically teaches Compound 524:
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(page 95), which falls into Formula (I). Mapping shown below:
18/573,342 Formula (I) Components
18/573,342 Formula (I)
Compound 523 (Barsanti)
Ring A
5-6-membered heteroaryl having 1-4 heteroatoms selected from N, O, S
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(R1)m
C1-6 aliphatic (Me); m = 1
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Z1
C
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Rb
Ring B
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Rc
Ring B
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Z2
C
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Rd
Ring B
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Re
Ring B
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Ring C
Divalent phenyl
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(R3)p
R3 = H; p = 1
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Ring D
6-10 membered partially unsaturated fused bicyclic ring having 0-5 heteroatoms selected from N, O, S
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(R8)q
-CF3
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(L-R9)t
L is a C1-4 straight hydrocarbon chain; R9 is a 3-7 membered saturated monocyclic heterocyclic ring having 1-2 heteroatoms selected from N, O, S; t = 1
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Regarding claim 1, Barsanti teaches a compound of Formula I: teaches Compound 524:
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(page 95).
Regarding claim 4, Barsanti teaches Compound 524:
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(page 95), wherein Ring A is
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.
Regarding claim 5, Barsanti teaches Compound 524:
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(page 95), wherein R1 is methyl.
Regarding claim 12, Barsanti teaches Compound 524:
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(page 95), wherein Ring B is
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.
Regarding claim 13, Barsanti teaches Compound 524:
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(page 95), wherein R2 is
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.
Regarding claim 14, Barsanti teaches Compound 524:
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(page 95), wherein R2 is a C1-6 aliphatic (methyl).
Regarding claim 16, Barsanti teaches Compound 524:
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(page 95), wherein Ring C is
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.
Regarding claim 17, Barsanti teaches Compound 524:
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(page 95), wherein R3 is H.
Regarding claim 19, Barsanti teaches Compound 524:
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(page 95), wherein L-R9 is
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.
Regarding claim 23, Barsanti teaches a pharmaceutical composition ([0006]; [0382]).
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.
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.
3. Claim(s) 1, 4-5, 12-14, and 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Barsanti (WO 2019/148005, published 1 Aug 2019, see IDS filed 11 June 2025) in view of Liang (WO 2022/169997, filed 3 Feb 2022, see IDS filed 17 July 2025) and Hu (Bioorg. Med. Chem., 2021, 38(116130), 1-11).
Barsanti (WO 2019/148005, published 1 Aug 2019, see IDS filed 11 June 2025) is applied as discussed in the 35 U.S.C. 102 rejection above.
The Examiner notes the relevant teachings with respect to claims 1, 4-5, 12-14, 16-17, 19, and 23 are set forth above and are incorporated herein by reference.
Additional relevant teachings are set forth below.
Barsanti teaches Cbl-B inhibitors and specifically teaches Compounds 130a, 168a, 335, and 518:
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,
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,
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, and
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, respectively (pages 69, 71, 80, and 94). Barsanti teaches that ubiquitination regulates diverse biology, and that synthesis and degradation of proteins in the cell is critical for cell cycle regulation, cell proliferation, apoptosis, and many other cellular processes ([0003]; [0004]). Barsanti teaches that the ability to modulate the ubiquitin proteasome pathway offers many opportunities to intervene in disease processes, such as enhanced degradation of oncogene products, reduced degradation of tumor-suppressor proteins, and modulation of immune cell response ([0004]). Barsanti further teaches that discovery of agents that modulate E3 enzymes accordingly provides potential therapies directed against disease processes via the E3 enzyme, such as the inhibitors therein ([0005]). Barsanti teaches that Compounds 130a, 168a, 335, and 518 had IC50 values of C, B, A, and B, respectively, wherein A is <100 nM, B is 100 nM ≤ B ≤ 300 nM, and C is 301 nM ≤ C ≤ 1000 nM (pages 795, 796, 800, and 803).
Regarding claim 1, Barsanti fails to teach
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.
Liang teaches Cbl-B inhibitors and specifically teaches Compounds 362 and 373:
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and
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, respectively (abstract; pages 140 and 142). Liang teaches that Cbl-B is a member of the Cbl family of RING E3 ubiquitin ligases and that a common function of Cbl family proteins is the negative regulation of the receptor tyrosine kinase signaling ([0003]). Liang teaches that Cb-B inhibition leads to immune activation, it has been expected that Cbl-B inhibitors are broadly active in multiple oncology indications ([0003]). Liang further teaches that Cbl-B-deficient mice spontaneously reject a variety of cancer tumors, including spontaneous solid tumors and hematopoietic malignancies ([0008]). Liang additionally teaches that c-Cbl and Cbl-B share high sequence homology at the N-terminus and that compound having activity against both Cbl-B and c-Cbl may still be beneficial if the inhibitory effect against Cbl-B is potent enough ([0010]). Liang teaches that Compounds 362 and 373 have an IC50 of 0.012 mM and 0.020 mM, respectively (pages 429-430).
Hu teaches an affinity prediction model for Cbl-B for developing small molecules inhibitors (abstract). Hu teaches that Cb-B participates in regulation of the ubiquitination of many substrates in cells and has been demonstrated to be an important immune checkpoint (page 2, column 1, paragraph 2). Hu teaches that Cbl-B is a novel target for development of small molecule tumor immunotherapy agents but that there are few reports of Cbl-B inhibitors, in particular, small molecules (page 2, column 1, paragraph 2). Hu teaches that there are only two co-crystal structures of Clb-B and the substrate motifs included in the protein data bank (ZAP-70 and EGFR; Zap-70 is a typical Cbl-B substrate) and that studying the Cbl-B substrate recognition pattern with the aid of known motifs is of great significance for the discovery and rational design of new small molecule inhibitors (page 2, column 1, paragraph 2). Hu teaches that the octapeptide, Pep-1 has an IC50 of 10.62 uM, but the pentapeptide, Pep-3, has an IC50 of 7.84 (Table 1, page 4). Hu teaches that the peptide truncation leading to unusual increase in affinity was previously reported on homologous protein c-Cbl and that their model indicated the pentapeptide had an alternative binding model occupying a previously uncharacterized groove (page 4, column 2, paragraph 2). Hu teaches that the acetyl group of the truncated pentapeptide, Pep-3, occupies the hydrophobic site formed by Ala296 and Ile310 during the entire MD simulation of 50 ns (page 4, column 2, paragraph 2; page 5, Figure 4B). Further, Hu teaches that the hydrogen bond occupancy rate with Cys289 and Thr290 increased in Pep-3 due to the acetyl-mediated conformational change to 119.3% (page 4, column 2, paragraph 2). Additionally, Hu teaches the hydrogen bonds of Pep-3 (page 5, Table 3). Further, Hu teaches that their findings are important reference information for guiding the development of Cbl-B small molecule inhibitors (page 6, column 1, paragraph 1).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to modify Compound 362 (
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) of Liang to incorporate (1) fluorophenyl (Compound 168a:
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) akin to Compound 518 (
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) of Barsanti (pages 71 and 94) to rigidify and affix the bond angles of the western fragment of the molecule and to optimize hydrophobic interactions with Ala296 and Ile310 as taught by Hu (page 4, column 2, paragraph 2; page 5, Figure 4B); (2) a benzoxazole core (Compound 130a:
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) akin to Compound 335 (
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) of Barsanti to optimize potency (pages 69, 80, 795, and 800) and to reduce the size of the core to remove negative interactions as taught by Hu (Figure 1C; Figure 4B; Figure 7); and (3) the alkylamide chain of Compound 373 (
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) as taught by Liang to optimize potency (pages 142 and 430) and hydrogen-bonding interactions with Pro71, Cys289, Ser288, and Thr290 (Figure 1D; page 5, column 1, paragraph 1; page 5, column 2, paragraph 1) to arrive at a compound of Formula (I):
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.
One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Barsanti teaches Cbl-B inhibitors and specifically teaches Compounds 130a, 168a, 335, and 518:
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,
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,
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, and
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, respectively,
-Barsanti teaches that ubiquitination regulates diverse biology, and that synthesis and degradation of proteins in the cell is critical for cell cycle regulation, cell proliferation, apoptosis, and many other cellular processes,
-Barsanti teaches that the ability to modulate the ubiquitin proteasome pathway offers many opportunities to intervene in disease processes, such as enhanced degradation of oncogene products, reduced degradation of tumor-suppressor proteins, and modulation of immune cell response,
-Barsanti teaches that discovery of agents that modulate E3 enzymes accordingly provides potential therapies directed against disease processes via the E3 enzyme, such as the inhibitors therein,
-Barsanti teaches that Compounds 130a, 168a, 335, and 518 had IC50 values of C, B, A, and B, respectively, wherein A is <100 nM, B is 100 nM ≤ B ≤ 300 nM, and C is 301 nM ≤ C ≤ 1000 nM,
-Liang teaches Cbl-B inhibitors and specifically teaches Compounds 362 and 373:
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and
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, respectively,
-Liang teaches that Cbl-B is a member of the Cbl family of RING E3 ubiquitin ligases and that a common function of Cbl family proteins is the negative regulation of the receptor tyrosine kinase signaling,
-Liang teaches that Cb-B inhibition leads to immune activation, it has been expected that Cbl-B inhibitors are broadly active in multiple oncology indications,
-Liang teaches that Cbl-B-deficient mice spontaneously reject a variety of cancer tumors, including spontaneous solid tumors and hematopoietic malignancies,
-Liang teaches that c-Cbl and Cbl-B share high sequence homology at the N-terminus and that compound having activity against both Cbl-B and c-Cbl may still be beneficial if the inhibitory effect against Cbl-B is potent enough,
-Liang teaches that Compounds 362 and 373 have an IC50 of 0.012 mM and 0.020 mM, respectively,
-Hu teaches an affinity prediction model for Cbl-B for developing small molecules inhibitors,
-Hu teaches that Cb-B participates in regulation of the ubiquitination of many substrates in cells and has been demonstrated to be an important immune checkpoint,
-Hu teaches that that Cbl-B is a novel target for development of small molecule tumor immunotherapy agents but that there are few reports of Cbl-B inhibitors, in particular, small molecules,
-Hu teaches that there are only two co-crystal structures of Clb-B and the substrate motifs included in the protein data bank (ZAP-70 and EGFR; Zap-70 is a typical Cbl-B substrate) and that studying the Cbl-B substrate recognition pattern with the aid of known motifs is of great significance for the discovery and rational design of new small molecule inhibitors,
-Hu teaches that the octapeptide, Pep-1 has an IC50 of 10.62 mM, but the pentapeptide, Pep-3, has an IC50 of 7.84,
-Hu teaches that the peptide truncation leading to unusual increase in affinity was previously reported on homologous protein c-Cbl and that their model indicated the pentapeptide had an alternative binding model occupying a previously uncharacterized groove,
-Hu teaches that the acetyl group of the truncated pentapeptide, Pep-3, occupies the hydrophobic site formed by Ala296 and Ile310 during the entire MD simulation of 50 ns,
-Hu teaches that the hydrogen bond occupancy rate with Cys289 and Thr290 increased in Pep-3 due to the acetyl-mediated conformational change to 119.3%,
-Hu teaches the hydrogen bonds of Pep-3,
-Hu teaches hydrogen-bonding interactions with Pro71, Cys289, Ser288, and Thr290 (Figure 1D; page 5, column 1, paragraph 1; page 5, column 2, paragraph 1), and
-Hu teaches that their findings are important reference information for guiding the development of Cbl-B small molecule inhibitors.
Further, structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1214 (Fed. Cir. 1995). Additionally, structural similarities have been found to support a prima facie case of obviousness. See, e.g., In re May, 574 F.2d 1082, 1093- 95, 197 USPQ 601, 610-11 (CCPA 1978) (stereoisomers); In re Wilder, 563 F.2d 457, 460, 195 USPQ 426, 429 (CCPA 1977) (adjacent homologs and structural isomers); In re Hoch, 428 F.2d 1341, 1344, 166 USPQ 406, 409 (CCPA 1970) (acid and ethyl ester); In re Druey, 319 F.2d 237, 240, 138 USPQ 39, 41 (CCPA 1963) (omission of methyl group from pyrazole ring). Generally, some teaching of a structural similarity will be necessary to suggest selection of the claimed species or subgenus. The closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. See, e.g., Dillon, 919 F.2d at 696, 16 USPQ2d at 1904 (and cases cited therein). See MPEP § 2144.08(II)(A)(4)(c). As the compound of Liang (Compound 373) differs from the elected species of the claimed invention via a methyl (methyl to hydrogen), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Thus, Liang teaches that L-R9 is
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.
As such, an artisan having ordinary skill in the art would have been motivated to substitute one known element for another to predictably arrive at a compound of Formula (I):
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.
Regarding claim 4, Liang teaches Compound 362:
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(abstract; page 140), wherein Ring A is
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. Barsanti teaches Cbl-B inhibitors and specifically teaches Compounds 130a, 168a, 335, and 518:
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,
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,
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, and
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, respectively (pages 69, 71, 80, and 94), wherein Ring A is
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.
Regarding claim 5, Liang teaches Compound 362:
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(abstract; page 140), wherein R1 is methyl. Barsanti teaches Cbl-B inhibitors and specifically teaches Compounds 130a, 168a, 335, and 518:
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,
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,
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, and
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, respectively (pages 69, 71, 80, and 94), wherein R1 is methyl.
Regarding claim 12, Barsanti teaches Compound 168a:
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(page 71), wherein Ring B is
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.
Regarding claim 13, Barsanti teaches Compounds 168a and 518:
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and
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, respectively (pages 71 and 94), wherein Ring B with its R2 substituent is fluorophenyl:
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.
Regarding claim 14, Barsanti teaches Compounds 168a and 518:
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and
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, respectively (pages 71 and 94), wherein R2 is fluoro.
Regarding claim 16, Liang teaches Compound 362:
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118
201
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(abstract; page 140), wherein Ring C is
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92
93
media_image26.png
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.
Regarding claim 17, Liang teaches Compound 362:
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118
201
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(abstract; page 140), wherein R3 is a 3-7 membered saturated monocyclic carbocyclic ring.
Regarding claim 18, Barsanti teaches Compounds 130a and 335:
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80
122
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and
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109
183
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, respectively (pages 69, 80, 795, and 800), wherein Ring D is
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107
153
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.
Regarding claim 19, Liang teaches Compound 373:
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94
204
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(page 142). Further, structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1214 (Fed. Cir. 1995). Additionally, structural similarities have been found to support a prima facie case of obviousness. See, e.g., In re May, 574 F.2d 1082, 1093- 95, 197 USPQ 601, 610-11 (CCPA 1978) (stereoisomers); In re Wilder, 563 F.2d 457, 460, 195 USPQ 426, 429 (CCPA 1977) (adjacent homologs and structural isomers); In re Hoch, 428 F.2d 1341, 1344, 166 USPQ 406, 409 (CCPA 1970) (acid and ethyl ester); In re Druey, 319 F.2d 237, 240, 138 USPQ 39, 41 (CCPA 1963) (omission of methyl group from pyrazole ring). Generally, some teaching of a structural similarity will be necessary to suggest selection of the claimed species or subgenus. The closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. See, e.g., Dillon, 919 F.2d at 696, 16 USPQ2d at 1904 (and cases cited therein). See MPEP § 2144.08(II)(A)(4)(c). As the compound of Liang (Compound 373) differs from the elected species of the claimed invention via a methyl (methyl to hydrogen), a person of ordinary skill in the art would expect the compounds to have similar properties and thus would contemplate making them to try and obtain compounds with improved properties. Thus, Liang teaches that L-R9 is
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55
109
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.
Regarding claim 20, Barsanti teaches Compounds 168a and 518:
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92
145
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and
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106
206
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, respectively (pages 71 and 94). Barsanti also teaches Compounds 130a and 335:
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80
122
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and
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109
183
media_image18.png
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, respectively (pages 69, 80, 795, and 800). Liang teaches Compounds 362 and 373:
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118
201
media_image20.png
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and
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94
204
media_image21.png
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, respectively (abstract; pages 140 and 142). Thus, the combination of Barsanti and Liang teaches a compound of Formula II-b:
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151
256
media_image28.png
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.
Regarding claim 21, Barsanti teaches Compounds 168a and 518:
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92
145
media_image17.png
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and
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106
206
media_image19.png
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, respectively (pages 71 and 94). Barsanti also teaches Compounds 130a and 335:
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80
122
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and
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109
183
media_image18.png
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, respectively (pages 69, 80, 795, and 800). Liang teaches Compounds 362 and 373:
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118
201
media_image20.png
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and
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94
204
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, respectively (abstract; pages 140 and 142). Thus, the combination of Barsanti and Liang teaches a compound of Formula II-b-9:
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177
296
media_image29.png
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.
Regarding claim 22, Barsanti teaches Compounds 168a and 518:
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92
145
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and
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106
206
media_image19.png
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, respectively (pages 71 and 94). Barsanti also teaches Compounds 130a and 335:
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80
122
media_image16.png
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and
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media_image18.png
109
183
media_image18.png
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, respectively (pages 69, 80, 795, and 800). Liang teaches Compounds 362 and 373:
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118
201
media_image20.png
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and
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94
204
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, respectively (abstract; pages 140 and 142). Thus, the combination of Barsanti and Liang teaches the compound,
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144
318
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.
Regarding claim 23, Liang teaches a pharmaceutical composition ([0207]). Additionally, Barsanti teaches a pharmaceutical composition ([0006]; [0382]).
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.
4. Claim 1, 4-5, 12-13, 16-17, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 7-8 of U.S. Patent No. 12,325,697. Although the claims at issue are not identical, they are not patentably distinct from each other.
U.S. Patent No. 12,325,697 teaches the general formula,
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142
238
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and specifically teaches the compound,
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164
230
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(claims 1 and 7). Additionally, ‘697 teaches a pharmaceutical composition of the compounds therein (claim 8). The compound,
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164
230
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, falls into Formula (I). Mapping shown below:
18/573,342 Formula (I) Components
18/573,342 Formula (I)
‘697 (claim 7, column 1101)
Ring A
5-6-membered heteroaryl having 1-4 heteroatoms selected from N, O, S
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67
57
media_image33.png
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(R1)m
C1-6 aliphatic (Me); m = 1
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67
57
media_image33.png
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Z1, Z2
C
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59
59
media_image34.png
Greyscale
Rb, Rd [Wingdings font/0xE0] Ring B
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media_image35.png
136
103
media_image35.png
Greyscale
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media_image34.png
59
59
media_image34.png
Greyscale
(R2)n
n = 0
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media_image34.png
59
59
media_image34.png
Greyscale
Ring C
6-membered heteroaryl having 1-4 heteroatoms: N, O, S
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media_image36.png
99
89
media_image36.png
Greyscale
(R3)p
R3 = 3-7-membered saturated monocyclic carbocyclic ring; p = 1
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media_image36.png
99
89
media_image36.png
Greyscale
Ring D
6-10 membered partially unsaturated fused bicyclic ring having 0-5 heteroatoms selected from N, O, S
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media_image37.png
140
85
media_image37.png
Greyscale
(R8)q
-CF3
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media_image37.png
140
85
media_image37.png
Greyscale
(L-R9)t
L = covalent bond; R9 = C(O)R; R = C1-6 aliphatic (Me); t = 0
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80
47
media_image38.png
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As such, ‘697 anticipates claim 1.
Regarding claim 4, ‘697 teaches the compound,
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164
230
media_image32.png
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(claims 1 and 7), wherein Ring A is
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86
105
media_image11.png
Greyscale
.
Regarding claim 5, ‘697 teaches the compound,
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164
230
media_image32.png
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(claims 1 and 7), wherein R1 is methyl.
Regarding claim 12, ‘697 teaches the compound,
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164
230
media_image32.png
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(claims 1 and 7), wherein
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media_image39.png
82
72
media_image39.png
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.
Regarding claim 13, ‘697 teaches the compound,
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164
230
media_image32.png
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(claims 1 and 7), wherein
PNG
media_image40.png
89
101
media_image40.png
Greyscale
.
Regarding claim 16, ‘697 teaches the compound,
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164
230
media_image32.png
Greyscale
(claims 1 and 7), wherein Ring C is
PNG
media_image41.png
88
101
media_image41.png
Greyscale
.
Regarding claim 17, ‘697 teaches the compound,
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164
230
media_image32.png
Greyscale
(claims 1 and 7), wherein R3 is a 3-7-membered saturated monocyclic carbocyclic ring.
Regarding claim 23, ‘697 teaches a pharmaceutical composition of the compounds therein (claim 8).
Conclusion
No claim is allowed.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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