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
1. This application is a 371 of PCT/US2021/025614 04/02/2021; PCT/US2021/025614 has PRO 63/004,717 04/03/2020.
Claims 1, 4, 9, 11, 14-17, 19-23, 25-40, 46, 51-54 are pending.
Response to Amendments
2. The rejection of canceled claims are withdrawn. The rejection of claim(s) 1-2, 4-5, 9, 11, 30-40, 51 under 35 U.S.C. 103 as being unpatentable over Hart WO 2016100166 A1 is withdrawn based upon the amendments. The limitations of claim 6, which was not rejected, have been incorporated into claim 1. The rejection of claims 1, 4, 9, 11, 14-17, 19, 20, 25-40, 46, 51 provisionally on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-12, 21-34 of copending Application No. 17/916,388 is maintained. Applicants’ representative’s arguments submitted on April 27, 2026 have been fully considered but are unpersuasive.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
3. Claims 1-2, 4-5, 9, 11, 14-17, 19, 20, 25-40, 46, 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-12, 21-34 of copending Application No. 17/916,388. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘388 application are drawn to the position isomers of the claimed compounds where the -OH group (U) is on the 5-position, while the instant claims are drawn to the 4- hydroxy indoles (U group). This can be seen by comparing the compound of copending claim 5:
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To the compound of Formula VIa of instant claims 5:
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OR Formula VIIIe in claim 22:
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To the Formula in IXa in claim 28 is the same except for this change in position now:
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The species in copending claim 30 are nearly identical to the elected species and others where the position of the -OH has simply migrated one position.
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Positional isomers, having the same radical on different positions of the molecule, are prima facie obvious, and require no secondary teaching. The experienced medicinal chemist, who would make the compounds, would be motivated to prepare these position isomers based on the expectation that such close analogues would have similar properties and upon the routine nature of such position isomer experimentation in the art of medicinal chemistry. It would be routine for the chemist to vary the point of attachment in order to increase potency and to establish better patent protection for her compounds. In re JONES 74 USPQ 152 (4-methyl naphthyl-1-acetic acid and 2-methyl naphthyl-1-acetic acid obvious over a reference teaching 1-methyl naphthyl-2-acetic acid), quoted with approval by Ex parte MOWRY AND SEYMOUR 91 USPQ 219, Ex parte Ullyot 103 USPQ 185 (4-hydroxy-1-oxo-1,2,3,4-tetrahydroisoquinoline obvious over a reference teaching 4-hydroxy-2-oxo-1,2,3,4-tetrahydroquinoline), "[p]osition isomers are recognized by chemists as similar materials", Ex parte BIEL 124 USPQ 109 (N-ethyl-3-piperidyl diphenylacetate obvious over a reference teaching N-alkyl-4-piperidyl diphenylacetate), "[appellant's arguments] do not, in any way, obviate the plain fact that appellant's DACTIL is an isomer of McElvain et al.'s compound. This close relationship places a burden on appellant to show some unobvious or unexpected beneficial properties in his compound in order to establish patentability", Ex parte Henkel 130 USPQ 474, (1-phenyl-3-methyl-4-hydroxypyrazole obvious over reference teaching 3-phenyl-5-methyl-4-hydroxypyrazole), "appellants have made no comparative showing here establishing the distinguishing characteristics they allege which we might consider as evidence that the claimed compounds are unobvious. It is clear from In re Henze, supra, and the authorities it cites, that at least this much is necessary to establish patentability in adjacent homologs and position isomers (emphasis added)".
In re Surrey 138 USPQ 67, (2,6-dimethylphenyl-N-(3-dimethylaminopropyl) carbamate obvious over a reference teaching 2,4-dimethylphenyl N-(3-dimethylaminopropyl) carbamate), In re MEHTA 146 USPQ 284, (2-(1-methyl)-pyrrolidylmethyl benzilate obvious over a reference teaching 3-(1-methyl)-pyrrolidylmethyl benzilate), "[t]he fact that a position isomer (emphasis added) of a compound is known is some evidence of the obviousness of that compound. Position isomerism (emphasis added) is a fact of close structural (emphasis in original) similarity …".Deutsche Gold-Und Silber-Scheideanstalt Vormals Roessler v. Commissioner of Patents, 148 USPQ 412, (1-azaphenothiazines obvious over references teaching 2-azaphenothiazines, 3-azaphenothiazines, and 4-azaphenothiazines), In re Crounse, 150 USPQ 554 (dye with para (CONH2) and ortho (OCH3) obvious over a dye with the same nucleus and meta (CONH2) and para (OCH3) group), Ex parte Allais, 152 USPQ 66, (3-b-aminopropyl-6-methoxyindole obvious over a reference teaching 3-b-aminopropyl-5-methoxyindole), In re Wiechert 152 USPQ 247, (1-methyl dihydrotestosterones obvious over a reference teaching 2-methyl dihydrotestosterones), Monsanto Company v. Rohm and Haas Company, 164 USPQ 556, at 559, (3',4'-dichloropropionanilide obvious over references teaching 2',4'-dichloropropionanilide and 2',5'-dichloropropionanilide), Ex parte Naito and Nakagawa, 168 USPQ 437, (3-phenyl-5-alkyl-isothiazole-4-carboxylic acid obvious over a reference teaching 5-phenyl-3-alkyl-isothiazole-4-carboxylic acid), "[t]his merely involves position isomers (emphasis added) and under the decisions cited, the examiner's holding of prima facie obviousness is warranted." In re Fouche, 169 USPQ 429, (10-aliphatic substituted derivatives of dibenzo[a,d]cycloheptadiene obvious over reference teaching 5-aliphatic substituted derivatives of dibenzo[a,d]cycloheptadiene). In re Hass 60 USPQ 552, which found a prima facia case of obviousness of 1-chloro-1-nitrobutane over 1-chloro-1-nitroisobutane taught in the prior art, Ex parte Ullyot, 103 USPQ 185, which found a prima facia case of of 2-oxo-quinolines obvious over prior art a 1-oxo-isoquinoline, In re FINLEY, 81 USPQ 383, 2-ethyl hexyl salicylate over octyl salicylate.
Ex parte Engelhardt, 208 USPQ 343 at 349, "[i]f functional groups capable of withdrawing or repelling electrons are located in the chain or ring (emphasis added) of a biologically active compound, transfer of such groups to other positions in which their electronic effects are lessened or enhanced may alter the biological activity of the modified compound. Hence, position isomerism (emphasis added) has been used as a tool to obtain new and useful drugs", In re Grabiak 226 USPQ 870, "[w]hen chemical compounds have "very close" structural similarities and similar utilities, without more a prima facie case may be made", In re Deuel 34 USPQ2d 1210, "a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (emphasis added) (e.g. ortho v. para)".
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
4. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID K O'DELL whose telephone number is (571)272-9071. The examiner can normally be reached on Monday - Friday 9:30 - 7:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID K O'DELL/ Primary Examiner, Art Unit 1621
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