DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This patent application claims priority from Provisional Application No. 18/911,325 filed October 11, 2023.
Status of the Claims
Claims 5, 8-10, 12, 13, 15, 17, 18, 20, 22-27, 29, 31-36, 38-42, 44, 45, 47-59, 61-63, 65-72, 74-83, and 85-93 have been cancelled. Claims 1-4, 6, 7, 11, 14, 16, 19, 21, 28, 30, 37, 43, 46, 60, 64, 73, and 84 are pending and the subject of the Office Action below.
Information Disclosure Statement
The Information Disclosure Statement submitted on January 22, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement has been acknowledged and considered by the Examiner where signed.
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.
Claims 1-4, 14, 16, 19, 21, 73, and 84 are anticipated by Chu et al.:
Claims 1-4, 14, 16, 19, 21, 73, and 84 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chu et al., U.S. Patent No. 12,054,496 issued on August 6, 2024.
The applied reference has a common applicant 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.
Applicants set forth a number of generic compound structures of varying scope (claims 1 and 2), as well as claims to specific compound embodiments (claims 3, 4, 14, 16, 19, 21)
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Claim 1 of the instant application is drawn to a genus of chemical compounds having the following generic structure:
wherein the corresponding R-group variables are defined within the claims filed in Applicant’s Preliminary Amendment filed on January 22, 2025.
Chu et al., disclose a genus of compound instant claim 1 reads on:
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Chu et al., Claim 1, col. 401, lines 1-18.
Chu et al., disclose a compound that meets each limitation of the genus of Claim 11:
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Chu et al., col. 132/L5-10, col. 139/L20-25, and col. 357/L40-45
Accordingly, claim 1 is anticipated.2
Claims 2-4, 14, 16, 19, and 21 further limit claim one to varying scopes of subgenus; each of these claims is also anticipated by the structure disclosed by Chu et al., shown above, and therefore anticipated.
Claims 1-4, 14, 16, 19, and 21 recite the same chemical compound as shown by Chu et al., above, and are therefore anticipated.
Claim 73 is directed towards a pharmaceutical composition comprising the compound genus of formula I of claim 1, and claim 84 is directed to methods of treating HIV with this genus of claim 1.
Chu et al., teaches both pharmaceutical compositions, and methods of treating HIV:
“Oral administration may be another route for administration of the compounds provided herein. Administration may be via, for example, capsule or enteric coated tablets. In making the pharmaceutical compositions that include at least one compound provided herein or pharmaceutically acceptable salts, isomer, or a mixture thereof, the active ingredient (such as a compound provided herein) is usually diluted by an excipient and/or enclosed within such a carrier that can be in the form of a capsule, sachet, paper or other container. When the excipient serves as a diluent, it can be in the form of a solid, semi-solid, or liquid material, which acts as a vehicle, carrier or medium for the active ingredient. Thus, the pharmaceutical compositions can be in the form of tablets, pills, powders, lozenges, sachets, cachets, elixirs, suspensions, emulsions, solutions, syrups, aerosols (as a solid or in a liquid medium), ointments containing, for example, up to 10% by weight of the active compound, soft and hard gelatin capsules, sterile injectable solutions, and sterile packaged powders.”
Chu et al., col. 96, lines 28-46 (emphasis added).
“Some examples of suitable excipients include lactose, dextrose, sucrose, sorbitol, mannitol, starches, gum acacia, calcium phosphate, alginates, tragacanth, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, sterile water, syrup, and methyl cellulose or any combinations thereof. The pharmaceutical compositions can additionally include lubricating agents such as talc, magnesium stearate, and mineral oil; wetting agents; emulsifying and suspending agents; preserving agents such as methyl and propylhydroxy-benzoates; sweetening agents; and flavoring agents; or any combinations thereof.”
Chu et al., col. 96, lines 47-57.
“For preparing solid compositions such as tablets, the principal active ingredient may be mixed with a pharmaceutical excipient to form a solid preformulation composition containing a homogeneous mixture of a compound described herein or pharmaceutically acceptable salts, isomer, or a mixture thereof. When referring to these preformulation compositions as homogeneous, the active ingredient may be dispersed evenly throughout the composition so that the composition may be readily subdivided into equally effective unit dosage forms such as tablets, pills and capsules.”
Chu et al., col. 97, lines 13-23.
“[308]The tablets or pills of the compounds described herein may be coated or otherwise compounded to provide a dosage form affording the advantage of prolonged action, or to protect from the acid conditions of the stomach. For example, the tablet or pill can include an inner dosage and an outer dosage component, the latter being in the form of an envelope over the former. The two components can be separated by an enteric layer that serves to resist disintegration in the stomach and permit the inner component to pass intact into the duodenum or to be delayed in release. A variety of materials can be used for such enteric layers or coatings, such materials including a number of polymeric acids and mixtures of polymeric acids with materials such as shellac, cetyl alcohol, and cellulose acetate.”
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Chu et al., col. 97, lines 25-38.
Chu et al., claim 12, col. 404, lines 30-52.
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Chu et al., claim 22, col. 407-408, lines 62-67 and 1-13
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Chu et al., claim 25, col. 408, lines 65-67
Chu et al., teaches dosing regimens, pharmacodynamic and pharmacokinetic attributes of chemical compounds within the genus of claim 1, including but not limited to the compound above (such as Example No. 1, Table 1):
“The compounds provided herein can be administered by any useful route and means, such as by oral or parenteral (e.g., intravenous) administration. Therapeutically effective amounts of the compound may include from about 0.00001 mg/kg body weight per day to about 10 mg/kg body weight per day, such as from about 0.0001 mg/kg body weight per day to about 10 mg/kg body weight per day, or such as from about 0.001 mg/kg body weight per day to about 1 mg/kg body weight per day, or such as from about 0.01 mg/kg body weight per day to about 1 mg/kg body weight per day, or such as from about 0.05 mg/kg body weight per day to about 0.5 mg/kg body weight per day. In some embodiments, a therapeutically effective amount of the compounds provided herein include from about 0.3 mg to about 30 mg per dose, or from about 30 mg to about 300 mg per dose, or from about 0.3 μg to about 30 mg per dose, or from about 30 μg to about 300 μg per dose.”
Chu et al., col. 102, lines 25-41
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Chu et al., col. 397, lines 1-16.
Accordingly, claims 1-4, 14, 16, 19, 21, 73, and 84 are anticipated by Chu et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6, 7, 11, 14, 16, 19, 21, 28, 30, 37, 43, 46, 60, 64, 73, and 84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 6, 8, 19, 20, 21, 23, 25, 26, 39, 48, 54, 66, and 77 of copending related U.S. Application No. 18/911,404 (the ‘404 application).
The limitations of the claims in the ‘404 patent and the application to the instant claims 1-4, 6, 7, 11, 14, 16, 19, 21, 28, 30, 37, 43, 46, 60, 64, 73, and 84 above, are hereby incorporated into the instant rejection.
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Claim 1 in the instant application is directed towards a genus of chemical compounds having the following generic structure:
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One particular species that Applicants claim within the genus of claim 1 is the following structure from claim 64:
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Claim 1 in the ‘404 application is drawn to the same genus of chemical compounds having the following generic structure:
One particular species that Applicants (‘404 application) claim within the genus of claim 1 is recited in claims 1 and 48:
“[Claim 1, L13-15] R1G is C3-6 cycloalkyl, C1-20alkyl or C1-20alkenyl; wherein the C3-6 cycloalkyl, C1-20alkyl or C1-20alkenyl is optionally substituted with a COOH, C3-6 cycloalkyl, C1-3 alkoxy, or -NHCOOR1H,”
“[Claim 48] The compound of claim 1, or the pharmaceutically acceptable salt thereof, wherein R1G is C3-6 cycloalkyl.”
As such, the genus and species of chemical compounds claimed in the instant application fall within the scope of claimed compounds in the ‘404 application and are not patentably distinct.
The composition claimed in claim 73 of the instant application is directed to the same genus of chemical structures of claim 1:
“A pharmaceutical composition comprising a therapeutically effective amount of a compound of claim 1, or pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient.”
Claim 66 of the ‘404 application meets this claim:
“A pharmaceutical composition comprising a therapeutically effective amount of a compound of claim 1, or pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient.”
Claim 84 in the instant application is drawn to a method comprising the administration of a compound of claim 1:
“A method of treating an HIV infection in a human having or at risk of having the infection, comprising administering to the human a therapeutically effective amount of a compound of claim 1, or a pharmaceutically acceptable salt thereof.”
Claim 77 in the ‘404 application is drawn to the same method of the same genus of chemical structures, comprising the administration of a compound of claim 1:
“A method of treating an HIV infection in a human having or at risk of having the infection, comprising administering to the human a therapeutically effective amount of a compound of claim 1 or a pharmaceutically acceptable salt thereof.”
Thus, facsimile claim 84 reads directly on claim 77 of the ‘404 application sans patentably distinct elements.
Claims 1-4, 6, 7, 11, 14, 16-19, 21, 28, 30, 37, 43, 46, 60, 64, 73, and 84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 7, 13, 21, 26, 27, 32, 33, 35, 37, 40, 46, and 57 of copending related U.S. Application No. 18/911,340 (the ‘340 application).
The limitations of the claims in the ‘340 patent and the application to the instant claims 1-4, 6, 7, 11, 14, 16-19, 21, 28, 30, 37, 43, 46, 60, 64, 73, and 84 above, are hereby incorporated into the instant rejection.
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Claim 1 of the ‘340 application is drawn to a genus of chemical compounds having the following generic structure:
One particular species that Applicants (‘340 application) claim within the genus of claim 1 is the following structure from claim 40:
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Claim 1 in the instant application discloses the elements of the species above and is not patentably distinct from the claims of the ‘340 application.
Claim 46 in the ‘340 application is directed to a composition of claim 1:
“A pharmaceutical composition comprising a therapeutically effective amount of a compound of claim 1, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient.”
The instant application meets the elements of this claim by the claim of the composition in claim 2 as discussed above.
Claim 57 in the ‘340 application is directed to a method for the administration of a compound of claim 1:
“A method of treating an HIV infection in a human having or at risk of having the infection, comprising administering to the human a therapeutically effective amount of a compound of claim 1, or a pharmaceutically acceptable salt thereof.”
The elements of this claim are met by claim 84 of the instant application as discussed above.
Accordingly, the claimed invention as a whole falls within the scope of the copending applications and is not patentably distinct.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed compounds fall within the scope of the copending applications discussed above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion and Inquiries
Claims 1-4, 6, 7, 11, 14, 16, 19, 21, 28, 30, 37, 43, 46, 60, 64, 73, and 84 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jarrod Stanley whose telephone number is (571)272-3520. The examiner can normally be reached Mon-Th 9-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren, can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARROD STANLEY/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 When R1 is –CH2-Phenyl; R2 is C1-3alkyl; R3 and R6 are halo; R4, R5, and R7 are H; R8 is C1-3alkyl.
2 See also pages 109, 116, and 134 of the first provisional application 63/328,061, filed on April 6, 2022.
