DETAILED ACTION
The amendment submitted on April 8, 2026 has been entered. Claims 2-3, 5, 10, and 35-36 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a modified tetracycline molecule or a pharmaceutical composition thereof, is acknowledged. All of the pending claims correspond to the elected invention, with claims drawn to the other invention having been cancelled.
Applicant’s election with traverse of the compound of “Formula 40” as the species for initial examination is also acknowledged. Applicant has amended the claims (except claim 10, discussed below) to delete this compound, so the search of the prior art has been expanded as explained in MPEP 803.02.
Withdrawn Objections and Rejections
The objection to claims 1-2 and 10 for a minor informality is withdrawn in view of appli-cant’s corrective amendment.
The rejection of claims 1-3, 5, 7, and 10 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is withdrawn because “pro-drugs” and “biologically active metabolites” have been deleted.
The rejection of claims 1-3, 5, 7, and 10 under 35 U.S.C. 112(b) as being indefinite is with-drawn in view of applicant’s amendment.
The rejection of claim 2 under 35 U.S.C. 112(d) as being of improper dependent form is withdrawn because this claim has been rewritten in independent form.
The rejection of claims 1-3, 5, and 7 under 35 U.S.C. 102(a)(1) as being anticipated by US 2010/0173991 A1 by Lorenz et al. is withdrawn because the compound of “Formula 40” has been deleted from the claims. Note, however, that the rejection of claim 10 over this reference is maintained as discussed below.
The rejections of claims 1-3, 5, and 7 for double patenting over U.S. Patent Nos. 11,542,227 B2 and 12,202,785 B2 are also withdrawn because the compound of “Formula 40” has been deleted from the claims. The provisional rejection of claims 1-3, 5, and 7 for double patenting over copending Application No. 18/975,409 is likewise withdrawn.
Response to Arguments
The rejection of claim 10 is maintained because it still reads on “Formula 40.” It appears to have been an oversight that claim 10 was not amended to exclude this compound in the same manner as the amendment to claim 2.
New Grounds for Rejection 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.
Claims 2-3, 5, 10, and 35-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2004/064728 A2 by Levy et al.
This reference discloses the following compound:
PNG
media_image1.png
192
416
media_image1.png
Greyscale
See page 32 of the reference. This is the 24th compound of instant claim 2 (the last compound on page 7 of the claims submitted on April 8, 2026). The subject matter of instant claim 3 appears to be an inherent property of the compound itself, so it has not been accorded patentable weight for the reasons discussed in MPEP 2112. The compound described in the reference is provided in an amount of “100 mg per kilogram of body weight” (p. 141, l. 31), which is the same dosage amount described in applicant’s own specification (p. 31, ll. 29-30), so the examiner concludes that the reference anticipates claim 5. This compound is referred to in applicant’s own specifi-cation (p. 24) as “Formula 24,” so the pharmaceutical compositions described in the reference (pp. 135 et seq.) meet the limitations of instant claims 10 and 35-36.
Maintained Rejections Claim Rejections – 35 USC § 102
The appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section are quoted above.
Claim 10 remains rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2010/0173991 A1 by Lorenz et al.
Lorenz (cited in the prior action) discloses “acetyl minocyclines of the formula (I),
PNG
media_image2.png
336
683
media_image2.png
Greyscale
wherein R¹ to R⁵=acetyl and/or H.” See the Abstract of Lorenz. This small genus is so particular that one would at once envisage a compound wherein R¹ is acetyl, R² is H, R³ is H, R⁴ is acetyl, and R⁵ is H. See MPEP 2131.02(III). Such a compound is a tautomer of the compound of Formula 40 and is therefore within the meaning of claim 10 notwithstanding applicant’s amendment.
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 possi-ble 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 provi-sions 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 accompa-nied 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.
Claim 10 remains rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,542,227 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘227 Patent is directed to a pharmaceutical method of using a compound of the following formula:
PNG
media_image3.png
334
683
media_image3.png
Greyscale
wherein “R¹ is methyl, ethyl, propyl, butyl, acetyl, alkyl, R² is H, OH or acetyl, R³ is H or acetyl, R⁴ is H or acetyl, and R⁵ is H or acetyl.” One would at once envisage a tautomer of applicant’s elected species from the small genus claimed in the ‘227 Patent.
Claim 10 remains rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,202,785 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above.
Claim 10 remains provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/975,409 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 statu-tory 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 Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https:// patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
May 6, 2026
Prosecution Insights