DETAILED ACTION
The amendment submitted on October 23, 2025 has been entered. Claims 1-3, 5, 7, 10-12, 15, 17-18, 20-21, and 24-27 are pending in the application. Claims 11-12, 15, 17-18, 20-21, and 24-27 are withdrawn. Claims 1-3, 5, 7, and 10 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, in the reply filed on October 23, 2025 is acknowledged. Claims 11-12, 15, 17-18, 20-21, and 24-27 are withdrawn from further consider-ation pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 23, 2025. Applicant’s request for rejoinder of the withdrawn claims is acknowledged.
Applicant’s election with traverse of the compound of Formula 40, illustrated below, as the species for initial examination in the reply filed on October 23, 2025 is also acknowledged:
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The traversal is on the grounds that “there is no additional burden for examination.” See appli-cant’s Remarks/Arguments, submitted October 23, 2025, at p. 17. This is not found persuasive because this is a national-stage application submitted under 35 U.S.C. 371, so the claims are subject to analysis for unity of invention as described in MPEP 823. A search or examination “burden” is not a relevant consideration for unity of invention. See MPEP 1850. The requirement is still deemed proper and is therefore made FINAL. Applicant timely traversed the election requirement in the reply filed on October 23, 2025. Claims 1-3, 5, 7, and 10 read on the elected species and are under consideration.
Claim Objections
Claim 1-2 and 10 are objected to because of the following informalities: the words “salts,” “pro-drugs,” “metabolites,” and “tautomers” should be in the singular (not plural). Appropriate correction is required.
Claim Rejections – 35 USC § 112(a), Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the inven-tion, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the inven-tion.
Claims 1-3, 5, 7, and 10 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
The written description requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was, in fact, in possession of the invention that is claimed. This promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practic-ing the invention for the duration of the patent’s term. To satisfy the written description require-ment, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed inven-tion. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. See MPEP 2163. At particular issue here are the “pro-drugs” and “biologically active metabolites” referred to in the claims. Applicant’s specification includes no descriptive words, structures, figures, diagrams, or chemical formulas for any “pro-drugs” and “biologically active metabolites.” Applicant’s specification does not even attempt to describe this subject matter. The search of the prior art reveals that there are no known pro-drugs or metabolites of the elected species. The examiner therefore concludes that the application lacks any written description of the claimed “pro-drugs” and “metabolites.”
Claim Rejections – 35 USC § 112(b), Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims partic-ularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-3, 5, 7, and 10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Minocycline has the following chemical structure (see applicant’s specification at p. 19):
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Note the hydroxyl group indicated by the arrow. Applicant’s elected species lacks this hydroxyl group, so presumably it would be called a “deoxy” minocycline, or something similar. But the chemical names recited in claim 1 make no provision for such a compound. It is not clear how the elected species is within the meaning of “a Deamino Diacetyl Minocycline, Methyl Ether Minocycline, Ethyl Ether Minocycline, Propyl Ether Minocycline, Butyl Ether Minocycline, Butyl Ether Monoacetyl Minocycline, Butyl Ether Diacetyl Minocycline, Buty Ether Triacetyl Mino-cycline, or Butyl Ether Tetra Acetyl Minocycline.” Or perhaps applicant intends the elected species to be a salt, pro-drug, biologically active metabolite, or tautomer of the foregoing, but it is not clear which of these would apply.
Furthermore, the search of the prior art reveals that “pro-drugs” and “metabolites” have no established meaning as they relate to applicant’s elected species. Applicant does not even attempt to describe these things in the specification, so the examiner concludes that they are indefinite.
Also in claim 7, “the modification” lacks antecedent basis.
Claim Rejections – 35 USC § 112(d), Improper Dependent Claims
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.
Claims 2 is rejected under 35 U.S.C. 112(d) 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. As explained in the rejection under § 112(b), above, the elected species appears to be outside the scope of claim 1. Claim 2 is there-fore broader in scope. Applicant may cancel the claim, amend the claim to place it in proper dependent form, rewrite it in independent form, or present a sufficient showing that it 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.
Claims 1-3, 5, 7, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2010/0173991 A1 by Lorenz et al.
Lorenz (cited in applicant’s IDS1) discloses “acetyl minocyclines of the formula (I),
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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 applicant’s elected species and therefore meets the limitations of at least claim 2. Claim 2 depends from claim 1, so the examiner concludes that claim 1 is also anticipated (see the rejection under § 112(b), above). The subject matter of claims 3 and 7 appear to be inherent properties of the compound and have therefore not been accorded patentable weight for the reasons discussed in MPEP 2111.04 and 2112. Lorenz also discloses pharmaceutical compositions (see claims 18-19 of the reference) and therefore meets the limitations of claims 5 and 10.
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.
Claims 1-3, 5, 7, and 10 are 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:
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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.
Claims 1-3, 5, 7, and 10 are 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.
Claims 1-3, 5, 7, and 10 are 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
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/interview practice. 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.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
January 7, 2026
1 See the information disclosure statement (IDS) submitted on September 14, 2022.