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 .
DETAILED ACTION
Claims 1, 2, 4, 6, 10, 12, 18, 27, 28, 33, 39, 40, 46-48, 50, 67, 68, 71 and 76 are pending in the application. Claims 1, 2, 4, 6, 10, 12, 18, 27, 28, 33, 39, 40, 46-48, 50, 67, 68, 71 and 76 are rejected.
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. 119(e) 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. 63/333,929, 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.
The provisional application fails to disclose:
the option for R3 to be -CO2(C1-C4 alkyl) or -C(O)Cy2 in claims 1 and 71;
the option for the corresponding R8 position to be anything other than hydrogen in claims 1 and 71;
the various species in instant claim 48 where R3 is -CO2(C1-C4 alkyl) or -C(O)Cy2 or R8 is not hydrogen;
the third species of claim 48 and the last species of claim 67.
Since the differences above affect the scope of instant claims 1, 2, 4, 6, 10, 12, 18, 27, 28, 33, 40, 48, 50, 67, 68, 71 and 76, the earliest effective filing date for these claims is April 20th, 2023.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on March 13th, 2025.
Claim Objections
In the definition of R3 in claim 1, the word “and” before the last option should be changed to “or”.
The definition of R10 is repeated twice in claim 71. See the seventh line of the claim and the second to last line of the claim. One instance should be deleted.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 39 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The first structure of claim 39 is not embraced by claim 33 or claim 1 since it does not contain the 1,4-dimethoxy pattern of claim 33 and does not meet the provision at the end of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 46 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 46 is replete with species where the group corresponding to R2 is -Cl, -CH3, or -Br when L is -C(O)NR10-, which do not meet the provision at the end of claim. See species on Applicant labeled pages 17 and 18 of the claim set dated 10/22/2024. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 46 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 46 recites the following species:
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Tetrazole does not fall within the permissible options of R4c since Cy1 cannot be a C1 heteroaryl and since Cy1 must be substituted. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 47 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 47 is replete with species where the group corresponding to R2 is -Cl, -CH3, -F, or -H, which do not meet the provision at the end of claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 6, 10, 18, 27, 28, 33, 40 and 50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huber et al. ACS Med. Chem. Lett. 2022, 13, 1311-1320, which was published July 15th, 2022.
Huber et al. teach the following compound on page 1313:
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The compound is embraced by the formula of instant claim 1 where R1 is C1 alkyl, Q1 is CH, R8 is hydrogen, R2 is C1 alkoxy, R7 is C1 alkyl, L is -C(O)NR10- where R10 is hydrogen, R3 is C4 alkyl, R4a, R4b and R4c are hydrogen and R4d is C2 alkoxy. Regarding the definition of R4d, the instant specification states that alkyl groups and corresponding variants thereof can be optionally substituted on pages 41-42. These definitions are embraced by instant claims 1, 2, 4, 6, 10, 18, 27, 28, 33 and 40. Regarding instant claim 50, the prior art teaches that the compounds of Figure 3 were tested in an assay on page 1314 (left column, first full paragraph), which would have an entailed a mixture with water, which is a pharmaceutically acceptable carrier. Applicant is further directed to compounds SJPYT-82, SJPYT-83, SJPYT-159, SJPYT-182, SJPYT-187, SJPYT-188 that are also embraced by analogous definitions or where R4c is instead an alkoxy group. Various compounds in Figure 8 are additionally embraced by were R4c is considered a substituted alkoxy or alkylamino group.
Claim(s) 1, 2, 4, 6, 10, 18, 27, 28, 33, 40, 50, 67 and 68 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. J. Med. Chem. 2022, 65, 16829-16859, which was published December 8th, 2022.
Li et al. teach the following compounds on page 16844:
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The compounds 80-82 and 85 are embraced by instant claim 1 where R1 is C1 alkyl, Q1 is CH, R8 is hydrogen, R2 is C1 alkoxy, R7 is C1 alkyl, L is -C(O)NR10- where R10 is hydrogen, R3 is C4 alkyl, R4a, R4b and R4c are hydrogen and R4d is C5 alkoxy. These definitions are embraced by instant claims 1, 2, 4, 6, 10, 18, 27, 28, 33 and 40. Regarding instant claim 50, the prior art teaches that compound 85 was tested in various assays on page 16841 (Figure 8), which would have an entailed a mixture with water, which is a pharmaceutically acceptable carrier. Regarding instant claim 67, the prior art teaches, for instance, the fourth compound of instant claim 67 in Table 5 (page 16838) as compound 63 along with biological testing corresponding to instant claim 68.
Claim(s) 1, 2, 4, 6, 10, 18, 27, 28, 33, 40 and 50 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2023/205807 A2 by Chen et al., or alternatively U.S. Patent PGPub No. 2026/0116867 by Chen et al., which both claim priority to U.S. Provisional Application No. 63/333,925, filed April 22nd, 2022.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The prior art teaches the following compound in Figure 3:
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Support can be found in Figure 3 of the provisional application. The compound is embraced by the formula of instant claim 1 where R1 is C1 alkyl, Q1 is CH, R8 is hydrogen, R2 is C1 alkoxy, R7 is C1 alkyl, L is -C(O)NR10- where R10 is hydrogen, R3 is C4 alkyl, R4a, R4b and R4c are hydrogen and R4d is C2 alkoxy. Regarding the definition of R4d, the instant specification states that alkyl groups and corresponding variants thereof can be optionally substituted on pages 41-42. These definitions are embraced by instant claims 1, 2, 4, 6, 10, 18, 27, 28, 33 and 40. Regarding instant claim 50, the prior art teaches preparation of the compound above on page 161 using an aqueous work-up, which is a pharmaceutically acceptable carrier. Support can be found on page 162 of the provisional application. Applicant is further directed to compounds SJPYT-82, SJPYT-83, SJPYT-159, SJPYT-182, SJPYT-187, SJPYT-188 that are also embraced by analogous definitions or where R4c is instead an alkoxy group. Various compounds in Figure 8 are additionally embraced by were R4c is considered a substituted alkoxy or alkylamino group. Support can be found in Figure 8 of the provisional application.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 2, 4, 6, 10, 18, 27, 28, 33, 40, 48 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. J. Med. Chem. 2022, 65, 16829-16859, which was published December 8th, 2022.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Li et al. teach in the abstract: “Herein, we report the structural optimization of a series of 1H-1,2,3-triazole-4-carboxamides compounds that led to the discovery of compound 85 as a selective and the most potent inverse agonist and antagonist of PXR, with low nanomolar IC50 values for binding and cellular activity.” Li et al. teach the following structure for compound 85 on page 16845:
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The compound 85 is embraced by instant claim 1 where R1 is C1 alkyl, Q1 is CH, R8 is hydrogen, R2 is C1 alkoxy, R7 is C1 alkyl, L is -C(O)NR10- where R10 is hydrogen, R3 is C4 alkyl, R4a, R4b and R4c are hydrogen and R4d is C5 alkoxy. These definitions are embraced by instant claims 1, 2, 4, 6, 10, 18, 27, 28, 33 and 40. Regarding instant claim 50, the prior art teaches that compound 85 was tested in various assays on page 16841 (Figure 8), which would have an entailed a mixture with water, which is a pharmaceutically acceptable carrier.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art anticipates instant claims 1, 2, 4, 6, 10, 18, 27, 28, 33, 40 and 50 where anticipation is the epitome of obviousness. The noted claims (and additional claim 48) embrace the following compound:
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The compound differs from prior art compound based on replacement of a hydrogen group with a methyl group on the group corresponding to the instant variable R4d.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
The prior art teaches in Scheme 6 that the corresponding position was tested with varying alkyl groups and where compound 85 of the prior art differs from a predecessor lead compound (compound 46) based on an analogous difference (Figure 9):
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“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
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homologs because
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homologs
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often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
The issue of patentability over the replacement of alkyl groups for hydrogen has arisen many times. For instance, the replacement of a methylene group with a dialkyl-substituted methylene group was determined to be prima facie obvious on the ground that “one skilled in the art would have been, prima facie, motivated to make the claimed compounds in the expectation that they, too, would possess antimicrobial activity." (In re Wood 199 USPQ 137) See also In re Doebel 174 USPQ 158 (where replacement of methyl for hydrogen on an amino nitrogen was considered prima facie obvious – at page 159); In re Druey 138 USPQ 39 (where replacement of methyl for hydrogen on a known compound was considered prima face obvious based on the homologous and close structural relationship to the known compound – at page 41); In re Lohr 137 USPQ 548 (where the replacement of a methyl group for a hydrogen on two positions of a tetrahydropyran ring on a known compound was not considered a patentable modification given the close structural relationship to the known compounds - at page 550); Ex parte Bluestone 135 USPQ 199 (where fungicidal compounds differing by hydrogen versus methyl on the nitrogen of a thiazolidine-2-thione ring were considered homologs and were not found to be patentable over each other without a showing of unexpected results – at page 200); Ex parte Weston 121 USPQ 429 (where the replacement of methyl for hydrogen on the nitrogen of a piperazine ring was not found to be a patentable modification); Ex parte Fauque 121 USPQ 425 (where di(methyl-furyl)-methane was considered a higher homolog of difuryl-methane and unpatentable without a showing of unexpected results - at page 426).
The motivation to make a substitution of an alkyl group for hydrogen stems from the fact that a person having ordinary skill in the art would expect that the compound could be prepared by the same method as taught by the prior art and have the same utility as the compounds taught by the prior art. In the interest of generating additional compounds that have the same utility as the compound taught by the prior, a person having ordinary skill in the art would seek to make additional compounds that are most closely related to compounds specifically taught by the prior art that have already been demonstrated to have the desired utility. As discussed supra, the replacement of hydrogen for an alkyl group falls under the well-established doctrine of homology, which assumes that homologous compounds are likely to have similar properties. Therefore, the instantly claimed compound, which differs by hydrogen/alkyl, over a compound of the prior art is unpatentable absent a showing of unexpected results. MPEP 2144.09 (VII) states “A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).” In the instant case, Applicant has not established unexpected properties between the instantly claimed compounds and the closest prior art homologs. In the instant case, a person having ordinary skill in the art at the time the invention was made would have been motivated to synthesize the instantly claimed homolog with the reasonable expectation that it would have the same utility as the closest structurally related compound taught by the prior art and with the motivation of obtaining additional useful compounds.
Claim(s) 1, 2, 4, 6, 10, 18, 27, 28, 33, 40, 50 and 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. J. Med. Chem. 2022, 65, 16829-16859, which was published December 8th, 2022.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Li et al. teach in the abstract: “Herein, we report the structural optimization of a series of 1H-1,2,3-triazole-4-carboxamides compounds that led to the discovery of compound 85 as a selective and the most potent inverse agonist and antagonist of PXR, with low nanomolar IC50 values for binding and cellular activity.” Li et al. teach the following structure for compound 85 on page 16845:
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The compound 85 is embraced by instant claim 1 where R1 is C1 alkyl, Q1 is CH, R8 is hydrogen, R2 is C1 alkoxy, R7 is C1 alkyl, L is -C(O)NR10- where R10 is hydrogen, R3 is C4 alkyl, R4a, R4b and R4c are hydrogen and R4d is C5 alkoxy. These definitions are embraced by instant claims 1, 2, 4, 6, 10, 18, 27, 28, 33 and 40. Regarding instant claim 50, the prior art teaches that compound 85 was tested in various assays on page 16841 (Figure 8), which would have an entailed a mixture with water, which is a pharmaceutically acceptable carrier.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art anticipates instant claims 1, 2, 4, 6, 10, 18, 27, 28, 33, 40 and 50 where anticipation is the epitome of obviousness. Instant claims 71 and 76 embrace the use of the prior art compound above in a method for decreasing an adverse drug reaction by administering and where the drug reaction is associated with the subject receiving treating for a disorder of uncontrolled cellular proliferation.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
Li et al. teach the following motivation for their study on page 16832:
Instead of designing or modifying compounds for each drug target, the undesired effect of drug-induced PXR activation may be countered by developing potent and selective PXR inhibitors (antagonists and/or inverse agonists) and coadministering them as codrugs with the PXR-activating drug. […]
Accordingly, a person having ordinary skill in the art in seeking to apply the compounds discovered therein would have been motivated to coadminister the compound cited above. The limitation of “for decreasing an adverse drug reaction” is considered an intended use where the only active step of claim 71 is administering the compound having the recited formula. Regardless, the prior art teaches compound 85 is an inverse agonist and antagonist of PXR and further teaches on page 16830: “PXR activation enhances drug metabolism, decreases drug efficacy, causes drug−drug interactions, and potentially leads
to treatment failure.6”
Claim(s) 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. J. Med. Chem. 2022, 65, 16829-16859, which was published December 8th, 2022, as applied to claims 1, 2, 4, 6, 10, 18, 27, 28, 33, 40, 50 and 71 above, in view of Schneider et al. J. Med. Chem. 2022, 65, 1552-1566.
Li et al. teach coadministration and that PXR causes drug-drug interactions but do not specifically address an embodiment of a subject receiving treatment for a disorder of uncontrolled cellular proliferation. Preceding the motivation discussed on page 16831, Li et al. describe attempts to avoid PXR activation including the following: “One approach to avoiding or decreasing PXR activation by drug candidates is to design or modify compounds that have reduced or no PXR activating function for each drug target of interest. […] Recently, Schneider et al. published a description of their novel inhibitors of B-Raf, based on dabrafenib, that do not bind or activate PXR.22” At least in the interest of comparing the approach of Li et al. to the compounds of Schneider et al., a person having ordinary skill in the art would have been motivated to test both approaches, i.e. administering the compounds of Schneider et al. as well as co-administering dabrafenib with compound 85 of Li et al. Regarding the specific application, Schneider et al. teach on page 1552: “DB is currently approved for the treatment of advanced melanoma and metastatic non-small cell lung cancer with a B-Raf-V600E mutation.1” Accordingly, a person having ordinary skill in the art would have been motivated to co-administer to a patient having the types of cancer taught by Schneider et al.
Claim(s) 1, 2, 4, 6, 10, 18, 27, 28, 33, 40, 50, 71 and 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2023/205807 A2 by Chen et al., or alternatively U.S. Patent PGPub No. 2026/0116867 by Chen et al., which both claim priority to U.S. Provisional Application No. 63/333,925, filed April 22nd, 2022.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches compounds of the following general formula as PXR modulators (page 3):
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As examples of the genus, the prior art teaches the following compound in Figure 3:
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Support can be found in Figure 3 of the provisional application. The compound is embraced by the formula of instant claim 1 where R1 is C1 alkyl, Q1 is CH, R8 is hydrogen, R2 is C1 alkoxy, R7 is C1 alkyl, L is -C(O)NR10- where R10 is hydrogen, R3 is C4 alkyl, R4a, R4b and R4c are hydrogen and R4d is C2 alkoxy. Regarding the definition of R4d, the instant specification states that alkyl groups and corresponding variants thereof can be optionally substituted on pages 41-42. These definitions are embraced by instant claims 1, 2, 4, 6, 10, 18, 27, 28, 33 and 40. Regarding instant claim 50, the prior art teaches preparation of the compound above on page 161 using an aqueous work-up, which is a pharmaceutically acceptable carrier. Support can be found on page 162 of the provisional application. Applicant is further directed to compounds SJPYT-82, SJPYT-83, SJPYT-159, SJPYT-182, SJPYT-187, SJPYT-188 that are also embraced by analogous definitions or where R4c is instead an alkoxy group. Various compounds in Figure 8 are additionally embraced by were R4c is considered a substituted alkoxy or alkylamino group. Support can be found in Figure 8 of the provisional application.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art anticipates instant claims 1, 2, 4, 6, 10, 18, 27, 28, 33, 40 and 50 where anticipation is the epitome of obviousness. Instant claims 71 and 76 embrace the use of the prior art compounds above in a method for decreasing an adverse drug reaction by administering and where the drug reaction is associated with the subject receiving treating for a disorder of uncontrolled cellular proliferation.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
The prior art teaches the following utility on page 5:
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Support can be found on page 6 of the provisional application. Accordingly, a person having ordinary skill in the art in seeking to apply the compounds above would have been motivated to administer the compounds to subjects for the treatment of uncontrolled cellular proliferation. The limitation of “for decreasing an adverse drug reaction” is considered an intended use where the only active step of claim 71 is administering the compound having the recited formula. Regardless, the prior art teaches in paragraph [0015] that kits may contain “instructions for decreasing an adverse drug reaction;”. Even if Applicant were to argue that the claims require administration of an additional compound besides a compound of the formula of claim 71, the prior art teaches combinations with additional agents on pages 115 and 116 (paragraphs [00234] and [00235]). Support can be found on pages 116 and 117 of the provisional application.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 4, 6, 10, 18, 27, 28, 33, 40, 50, 71 and 76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 6, 8, 9, 13, 14, 17, 22, 28, 32, 39, 41-44, 61, 77 and 126 of copending Application No. 18/858,684 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending case recite compounds embraced by the instant claims. Claim 41 of the copending case recites the following compound:
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The compound is embraced by the formula of instant claim 1 where R1 is C1 alkyl, Q1 is CH, R8 is hydrogen, R2 is C1 alkoxy, R7 is C1 alkyl, L is -C(O)NR10- where R10 is hydrogen, R3 is C4 alkyl, R4a, R4b and R4c are hydrogen and R4d is C2 alkoxy. Regarding the definition of R4d, the instant specification states that alkyl groups and corresponding variants thereof can be optionally substituted on pages 41-42. These definitions are embraced by instant claims 1, 2, 4, 6, 10, 18, 27, 28, 33 and 40. Regarding instant claim 50, claim 44 of the copending case recites analogous compositions. Regarding instant claim 71, claim 77 of the copending case recites an analogous method. Regarding instant claim 76, claim 61 of the copending case recites application in treating a disorder of uncontrolled cellular proliferation. The instant claims do not require separate administration of anything beyond the compound of the formula of claim 71.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 4, 6, 10, 12, 18 and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,516,051. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite compounds embraced by instant claims. Claim 15 of the patent recites the following compounds:
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The compounds are embraced by the formula of instant claim 1 where R1 is C1 alkyl, Q1 is CH, R8 is C4 alkoxy (further substituted), R2 is C1 alkoxy, R7 is C1 alkyl, L is -C(O)NR10- where R10 is hydrogen, R3 is C4 alkyl or CO2(C1 alkyl), R4a, R4b and R4c are hydrogen and R4d is C6 alkoxy. Regarding the definition of R8, the instant specification states that alkyl groups and corresponding variants thereof can be optionally substituted on pages 41-42. These definitions are embraced by instant claims 1, 2, 4, 6, 10, 12 and 18. Regarding instant claim 50, claim 6 of the patent recites analogous compositions.
Claims 1, 2, 4, 6, 10, 12, 18, 50, 71 and 76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-17 and 21-33 of copending Application No. 18/902,844 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending case recites methods of using compounds embraced by instant claims. Claim 33 of the copending case recites methods of using the following compounds:
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The compounds are embraced by the formula of instant claim 1 where R1 is C1 alkyl, Q1 is CH, R8 is C4 alkoxy (further substituted), R2 is C1 alkoxy, R7 is C1 alkyl, L is -C(O)NR10- where R10 is hydrogen, R3 is C4 alkyl or CO2(C1 alkyl), R4a, R4b and R4c are hydrogen and R4d is C6 alkoxy. Regarding the definition of R8, the instant specification states that alkyl groups and corresponding variants thereof can be optionally substituted on pages 41-42. These definitions are embraced by instant claims 1, 2, 4, 6, 10, 12 and 18. Regarding instant claim 50, a person having ordinary skill in the art seeking to practice the methods of the copending case would have been motivated to include a carrier for ease of administration. Regarding instant claims 71 and 76, the copending case recites the treatment of cancers, which are characterized by uncontrolled cellular proliferation, in claims 16 and 17 of the copending case. The instant claims do not require separate administration of anything beyond the compound of the formula of claim 71.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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