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 .
Claims 1-20 are pending in this application.
Claim Rejections - 35 USC § 112
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 invention, 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 invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, 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 of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for pain, does not reasonably provide enablement for alcohol use disorder (AUD), substance use disorder (SUD), tobacco use or proinflammatory disorders. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In evaluating the enablement question, several factors are to be considered. In re
Wands, 8 USPQ2d 1400 (Fed. Cir. 1988); Ex parte Forman, 230 USPQ 546. The factors
include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack
thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of
working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
The nature of the instant invention has claims, which embrace substituted
tetracene compounds.
HOW TO USE: Claims 1-20 are drawn to the method of treating alcohol use disorder (AUD), substance use disorder (SUD), tobacco use or proinflammatory disorders, which is associated with reducing binding to a microbial ribosome. Any evidence presented must be commensurate in scope with the claims and must clearly demonstrate the effectiveness of the claimed compounds. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The scope of claims 1-20 includes diseases and/or conditions not even known at this time, which may be associated with reduced binding to a microbial ribosome. While the treatment of pain has been linked with reduced binding to a microbial ribosome does not recognize use of such inhibitors as broad-based drugs for treating all disorders instantly embraced. “Alcohol use disorder”, “substance use disorder”, “tobacco use” or “proinflammatory disorders” cannot be deemed enabled. The notion that a compound could be effective against alcohol use disorder (AUD), substance use disorder (SUD), tobacco use or proinflammatory disorders in general is contrary to our current understanding of how pharmacologicals work. All attempts to find a pharmaceutical to treat alcohol use disorder (AUD), substance use disorder (SUD), tobacco use or proinflammatory disorders, etc. generally have thus failed.
The scope of “treating …... alcohol use disorder (AUD), substance use disorder (SUD), tobacco use … or proinflammatory disorders” cannot be deemed enabled. The notion that a compound could be effective against chemical dependencies in general is contrary to our current understanding of how chemical dependencies operate. There is not, and probably never will be, a pharmacological treatment for “alcohol use disorder (AUD), substance use disorder (SUD), tobacco use … or proinflammatory disorders” generally. That is because “alcohol use disorder (AUD), substance use disorder (SUD), tobacco use … or proinflammatory disorders” is not a single disease or cluster of related disorders, but in fact, a collection with relatively little in common. Addiction to barbiturates, alcohol, cocaine, opiates, amphetamines, benzodiazepines, nicotine, etc. all involve different parts of the CNS system; different receptors in the body. For example, cocaine binds at the dopamine re-uptake site. Heroin addiction, for example, arises from binding at the opiate receptors, cigarette addiction from some interaction at the nicotinic acid receptors, many tranquilizers involve the benzodiazepine receptor, alcohol involves yet another system, etc. All attempts to find a pharmaceutical to treat chemical addictions generally have thus failed.
Additionally, the claims recite the limitation "proinflammatory disorder". However, the present specification lacks definition/identification of what is meant/encompassed by the term. Is proinflammatory disorder the same or different from inflammatory disorder?
The specification also lacks definition/identification of what is meant/encompassed by the term “candidate drug”. The is no written description of what is meant by “candidate drug”.
In view of the lack of direction provided in the specification regarding starting materials, the lack of working examples, and the general unpredictability of chemical reaction, it would take an undue amount of experimentation for one skilled in the art to make the claimed compounds and therefore practice the invention. To be enabling, the specification of a patent must teach those skilled in the art how to make and use the scope of the claimed invention without undue experimentation. The applicants are not entitled to preempt the efforts of others. The test for determining compliance with 35 U.S.C. § 112, is whether the applicants have clearly defined their invention.
Where the utility is unusual or difficult to treat or speculative, the examiner has authority to require evidence that tests relied upon are reasonably predictive of in vivo efficacy by those skilled in the art. See In re Ruskin, 148 USPQ 221; Ex parte Jovanovics, 211 USPQ 907; MPEP 2164.05(a).
Patent Protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
As stated in the MPEP, 2164.08 ''[t]he Federal Circuit has repeatedly held that the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. ln re Wright, 999 F.2d 1557, 1561 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Nevertheless, not everything necessary to practice the invention need be disclosed. In fact, what is well known is best omitted. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). AII that is necessary is that one skilled in the art be able to practice the claimed invention, given the Ievel of knowledge and skill in the art. Further the scope of enablement must only bear a reasonable correlation to the scope of the claims. See, e.g., In re Fisher, 427 F.2d 833, 839,166 USPQ 18, 24 (CCPA 1970). As concerns the breadth of a claim relevant to enablement, the only relevant concern should be whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged pioneer status of invention irrelevant to enablement determination.''
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The following reasons apply:
Claims 1, 9, 12 and 20 recites the broad recitation substance use disorder, and the claim also recites Alcohol use disorder and tobacco us which is the narrower statement of the limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 1, 9, 12, 20 and claims dependent thereon are vague and indefinite in that it is not known what is meant by “Derivative” which implies more then what is positively recited.
Claims 1, 9, 12 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the definition of R1 which is not stated in the form of a proper Markush grouping.
Claims 1, 9, 12 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the “0” in the definition of R3.
Claims 1, 9, 12 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the variable R5 which is not defined within the claim.
Claims 1, 9, 12 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the definition of R5 where there is no variable R5 in the formula.
Claim 2 recites the limitation "
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" in the 2nd, 3rd, 4th and 5th species on page 2 with respect to ring A substitution at 12a and 1 and the bonds between 1 and 12a and 4 and 4a. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "
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" in the 1st, 2nd, 3rd and 4th species on page 3 with respect to ring A substitution at 12a and 1 and the bonds between 1 and 12a and 4 and 4a. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 is vague and indefinite in that it is not known what is meant by the second occurrence of the 2nd species on page 4 which is a duplicate of the 1st species on page 2.
Claim 2 is vague and indefinite in that it is not known what is meant by the second occurrence of the 3rd species on page 4 which is a duplicate of the species on page 1.
Claim 2 recites the limitation "
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" in the 4th species on page 4 with respect to ring A substitution at 4 where the N(CH3)2 is missing. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "doxycycline, minocycline, or tigecycline" in the definition of the modified tetracycline. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "
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" in the 3rd and 4th species on page 6 with respect to ring A substitution at 12a and 1 and the bonds between 1 and 12a and 4 and 4a. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "
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" in the 1st, 2nd, 3rd, 4th, 5th and 6th species on page 7 with respect to ring A substitution at 12a and 1 and the bonds between 1 and 12a and 4 and 4a. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 is vague and indefinite in that it is not known what is meant by the second occurrence of the 4th species on page 8 which is a duplicate of the 2nd species on page 6.
Claim 10 is vague and indefinite in that it is not known what is meant by the second occurrence of the 5th species on page 8 which is a duplicate of the 1st species on page 6.
Claim 10 recites the limitation "
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" in the 1st species on page 9 with respect to ring A substitution at 4 where the N(CH3)2 is missing. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "
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" in the 3rd and 4th species on page 10 with respect to ring A substitution at 12a and 1 and the bonds between 1 and 12a and 4 and 4a. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "
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" in the 1st, 2nd, 3rd, 4th, 5th and 6th species on page 11 with respect to ring A substitution at 12a and 1 and the bonds between 1 and 12a and 4 and 4a. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 is vague and indefinite in that it is not known what is meant by the second occurrence of the 4th species on page 12 which is a duplicate of the 2nd species on page 10.
Claim 12 is vague and indefinite in that it is not known what is meant by the second occurrence of the 5th species on page 12 which is a duplicate of the 1st species on page 10.
Claim 12 recites the limitation "
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" in the 1st species on page 13 with respect to ring A substitution at 4 where the N(CH3)2 is missing. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "doxycycline, minocycline, or tigecycline" in the definition of the modified tetracycline. There is insufficient antecedent basis for this limitation in the claim.
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) 1-8 and 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated
by Abato et al. (US 2007/0093455).
Regarding claims 1-2, 12-13 and 20 Abato teaches a method of treating Alcohol use disorder (AUD), substance use disorder (SUD), tobacco use, pain, or proinflammatory disorders comprising: providing a subject with an effective amount of a modified tetracycline or derivative thereof to ameliorate or eliminate the AUD, SUD, tobacco use, pain, or proinflammatory disorder (para [0310], treating a tetracycline responsive state; para [0313]-[0314], Inflammatory disorders are generally characterized by.pain), and wherein the modified tetracycline or derivative thereof has reduced binding to a microbial ribosome (para [0312], the tetracycline compounds of the invention are essentially non-antibacterial) and has the formula specified in the claim and represented by the fourth structure listed in claim 2 (para [0267], Table 2, pg 18, Compound W:
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.
Regarding claims 3 and 14, Abato teaches the method of claim 1, wherein the modified
tetracycline has moderate to no antibacterial activity (para [0312], the tetracycline
compounds of the invention are essentially non-antibacterial) or has moderate to no
antifungal activity (para [0267], Table 2, pg 18, Compound W. Since Abato discloses the
same compound specified by the Applicant as having no antifungal activity [see para
[0013]-[0014] of the Applicant's specification], the compound of Abato inherently has no
antifungal activity).
Regarding claims 4 and 15, Abato teaches the method of claim 1, wherein the modified
tetracycline is a doxycycline, minocycline (para [0267], Table 2, pg 18, Compound W), or
tigecycline.
Regarding claims 5 and 16, Abato teaches the method of claim 1, wherein the ribosome is a bacterial ribosome (para [0312], the tetracycline compounds of the invention are essentially non-antibacterial).
Regarding claims 6 and 17, Abato teaches the method of claim 1, wherein the modification at least one of: produces steric hindrance, blocks hydrogen bonding, or change coordination with divalent cations (para [0267], Table 2, pg 18, Compound W; Since Abato discloses the same compound specified by the Applicant [see para [0013] of the Applicant's specification], the modified tetracycline compound disclosed in Abato inherently produces steric hindrance, blocks hydrogen bonding, or change coordination with divalent cations).
Regarding claims 7 and 18, Abato teaches the method of claim 1, wherein the modified
tetracycline further comprises a pharmaceutically acceptable buffer, excipient, filler, or
carrier (para [0108], [0343]).
Regarding claims 8 and 19, Abato teaches the method of claim 1, wherein the modified
tetracycline is adapted for administration orally, enterally, parenterally, intramuscularly,
intravenously, or intraperitoneally (para [0343], [0353)-[0354]).
Therefore, the claimed invention is anticipated by the cited reference
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.
Claims 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over
Abato et al. (US 2007/0093455).
Regarding claims 12-13 and 20, Abato teaches a method of treating Alcohol Use Disorder (AUD), substance use disorder (SUD), tobacco use, pain, or proinflammatory disorders comprising: providing a subject with an effective amount of a modified tetracycline or derivative thereof to ameliorate or eliminate the AUD, SUD, tobacco use, pain, or proinflammatory disorder (para [0310], treating a tetracycline responsive state; para [0313]-[0314], Inflammatory disorders are generally characterized by pain), and wherein the modified tetracycline or derivative thereof has reduced binding to a microbial ribosome (para [0312], the tetracycline compounds of the invention are essentially non-antibacterial) and has the formula specified in the claim and represented by the fourth structure listed in claim 20 (para [0267], Table 2, pg 18, Compound W:
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), in a pharmaceutically acceptable carrier (para [0343]).
Abato does not expressly teach the step of identifying a subject in need of treatment for at least one of AUD, Substance Use Disorder (SUD), tobacco use, pain, or a proinflammatory disorder, but does teach treating inflammatory process associated states in which inflammatory factors are present in an area in aberrant amounts (para [0313]). Based on such teachings, it would have been obvious to one of ordinary skill in the art to include the step of identifying a subject in need of treatment, by detecting the presence of said inflammatory factors in said subject, through routine experimentation, in order to enhance the efficacy of the method disclosed in Abato toward treating pain and proinflammatory disorders in said subject.
Regarding claim 14, Abato teaches the method of claim 12, wherein the modified tetracycline has moderate to no antibacterial activity (para [0312], the tetracycline compounds of the invention are essentially non-antibacterial) and has moderate to no antifungal activity (para [0267], Table 2, pg 18, Compound W; Since Abato discloses the same compound specified by the Applicant as having no antifungal activity [see para [0013]-[0014] of the Applicant's specification], the compound of Abato inherently has no antifungal activity).
Regarding claim 15, Abato teaches the method of claim 12, wherein the modified tetracycline is a doxycycline, minocycline (para[0267], Table 2, pg 18, Compound W), or tigecycline.
Regarding claim 16, Abato teaches the method of claim 12, wherein the ribosome is a bacterial ribosome (para [0312], the tetracycline compounds of the invention are essentially non-antibacterial).
Regarding claim 17, Abato teaches the method of claim 12, wherein the modification at least one of: produces steric hindrance, blocks hydrogen bonding, or change coordination with divalent cations (para [0267], Table 2, pg 18, Compound W; Since Abato discloses the same compound specified by the Applicant (see para [0013] of the Applicant's specification], the modified tetracycline compound disclosed in Abato inherently produces steric hindrance, blocks hydrogen bonding, or change coordination with divalent cations).
Regarding claim 18, Abato teaches the method of claim 12, wherein the modified tetracycline further comprises a pharmaceutically acceptable buffer, excipient, filler, or carrier (para[0108], [0343]).
Regarding claim 19, Abato teaches the method of claim 12, wherein the modified
tetracycline is adapted for administration orally, enterally, parenterally, intramuscularly,
intravenously, or intraperitoneally (para [0343], [0353]-[0354)).
For these reasons, the claimed invention is rendered prima facie obvious.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over
Abato in view of Kantor et al. (US2005/0048574).
Regarding claims 9-10, Abato teaches a method of evaluating a candidate drug (para [0401], Evaluation of efficacy in a Rat model of Carrageenan Induced Paw Edema) believed to be useful in treating pain, or proinflammatory disorders (para [0310], [0313)-[0314], Inflammatory disorders are generally characterized by pain), the method comprising:
b) administering a candidate drug to a first subset of the subjects (para [0401], Test compounds), and no treatment to a second set of subjects (para [0401], untreated control), wherein the candidate drug is a C6' modified tetracycline that has the formula specified in the claim and represented by the fourth structure listed in claim 11 (para [0267], Table 2, pg 18, Compound W); and
c) determining if the candidate drug reduces the pain, or proinflammatory disorders that is statistically significant as compared to any reduction occurring in the second subset of subjects, wherein a statistically significant reduction indicates that the candidate drug is useful in treating pain, or proinflammatory disorders (para [0401], compound A caused a 60% decrease in paw inflammation relative to the untreated control).
Abato does not teach testing the candidate drug in human patients; nor does it
teach the steps of:
a) measuring the Alcohol Use Disorder (AUD), substance use disorder (SUD), tobacco
use, pain, or proinflammatory disorders from a set of patients;
b) administering a placebo to a second subset of the patients;
c) repeating step a) after the administration of the candidate drug or the placebo.
In a similar invention, Kantor teaches a method of evaluating a candidate drug believed to be useful in treating an inflammatory disorder (para [0176], treating RA), in human patients (para [0176], clinical trial) comprising:
a) measuring the inflammatory disorder from a set of patients (para [0176], assays are performed on each subject's sample to measure levels of a marker);
b) administering a placebo to a second subset of the patients (para [0176], a control group, to which a placebo is administered);
c) repeating step a) after the administration of the candidate drug or the placebo (para[0176]-[0177]) and
d) determining if the candidate drug reduces the inflammatory disorders that is statistically significant as compared to any reduction occurring in the second subset of patients, wherein a statistically significant reduction indicates that the candidate drug is useful in treating the inflammatory disorder (para [0177]).
It would have been obvious to one of ordinary skill in the art to combine the teachings of
Kantor with those of Abato, as both are directed to methods of evaluating the efficacy of
a drug toward treating an inflammatory disorder, and include the steps of:
a) measuring the pain, or proinflammatory disorders from a set of human patients;
b) administering a placebo to a second subset of the patients;
c) repeating step a) after the administration of the candidate drug or the placebo, as disclosed in Kantor in the method of Abato, in order to enhance the efficacy of determining the usefulness of the modified tetracycline toward treating pain or proinflammatory disorders in a patient.
Regarding claim 11, Abato and Kantor teach the method of claim 9, wherein Abato further teaches that the modification at least one of: produces steric hindrance, blocks hydrogen bonding, or change coordination with divalent cations (para [0267], Table 2, pg 18,Compound W; Since Abato discloses the same compound specified by the Applicant [see para [0013] of the Applicant's specification], the modified tetracycline compound disclosed in Abato inherently produces steric hindrance, blocks hydrogen bonding, or change coordination with divalent cations).
For these reasons, the claimed invention is rendered prima facie obvious
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,486,219. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of treating alcohol use disorder, substance use disorder, tobacco use, pain or proinflammatory disorders comprising one or more modified tetracyclines of the formula of the instant application embraces many of the compounds 1 to 71, 74 to 78 and 80 to 85 in U.S. ‘219.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,202,785. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of treating substance use disorder or pain comprising one or more modified tetracyclines of the formula of the instant application embraces many of the compounds of the formula in claim 1 of U.S. ‘785.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,542,227. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of treating substance use disorder comprising one or more modified tetracyclines of the formula of the instant application embraces many of the compounds of the formula in claim 1 of U.S. ‘227.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 44-61 of copending Application No. 19/389,759 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of treating alcohol use disorder, substance use disorder, tobacco use, pain or proinflammatory disorders comprising one or more modified tetracyclines of the formula of the instant application embraces many of the compounds 1 to 85 in 19/389,759.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 3, 5, 10, 35 and 36 of copending Application No. 17/908,999 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of treating alcohol use disorder, substance use disorder, tobacco use, pain or proinflammatory disorders comprising one or more modified tetracyclines of the formula of the instant application embraces many of the compounds 1 to 48 in 17/908,999.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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, Jeffrey H. Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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