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 .
Response to Amendment
2. Applicant’s amendment and response, submitted October 31, 2025, has been reviewed by the examiner and entered of record in the file.
3. Claims 1 and 3 are amended, and claim 13 is newly added.
4. Claims 2 and 4, drawn to non-elected compound species of formula I, and claim 11, directed to the nonelected invention of Group II, remain withdrawn from consideration.
Status of the Claims
5. Thus, the scope of the invention of the elected subject matter is expanded, as follows:
a method of treating tuberculosis caused by Mycobacterium tuberculosis in a host organism comprising providing the host organism with a therapeutically effective amount of a host ACC2 inhibitor according to formula II, recited in claim 3, and at least one additional pharmaceutically active compound that is an antibiotic (selected from the group consisting of isoniazid, rifampicin, ethambutol, pyrazinamide, rifapentine, rifabutin, aminoglycosides, polypeptides, fluorquinolones, cycloserine, terizidone, thioacetone, p-aminosalicylic acid, clofazimine, linezolid, amoxicillin, clavulanate, thioacetazone, imipenem, cilastatin, clarithromycin, delamanid, and bedaquiline), and optionally a pharmaceutically acceptable carrier, diluent, or excipient.
6. The non-elected subject matter of claims 1, 3 and 7-10, 12 and 13, in part, remains withdrawn from further consideration.
7. Claims 1, 3, 5, 7-10, 12 and 13 are under examination and are the subject of this office action.
Previous Claim Rejections - 35 USC § 112(b)
8. Claims 1, 3, and 7 were previously 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.
9. Claims 1 and 7 were previously rejected as being unclear regarding the recitation of plurals.
10. Claims 3, 5, 8-10 and 12 were previously rejected as being dependent upon and including all of the limitations of claim 1.
11. In view of Applicant’s amendment to claim 1, the previous indefinite rejections of claims 1, 3, 5, 8-10 and 12 are withdrawn.
12. Claim 3 was previously rejected regarding the variables R10 and Y. In view of Applicant’s amendatory changes, the rejection of claim 3 is withdrawn.
New Claim Rejections - 35 USC § 112(b)
13. 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.
14. Claims 1, 3, 5, 7-10, 12 and 13 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.
15. Claim 1 is unclear in the following aspects:
(a) Claim 1 recites the limitation “does not affect the viability of the host macrophages” in lines 11-12, however there is insufficient antecedent basis for this recitation in in the claim, because the limitation “host macrophages” has not been previously recited. While the preamble recites “macrophage host cells,” this is not consistent with the term “host macrophages.”
(b) Claim 1 recites the limitation: "wherein the administering step… does not decrease the replication rate of M. tuberculosis in the host organism," [emphasis added] in lines 12-13. There is insufficient antecedent basis for the limitation of “the replication rate” in the claim, because this limitation has not been previously recited.
It is also suggested that the limitation: “wherein the mycobacterial disease is tuberculosis caused by the bacteria “Mycobacterium tuberculosis,” be incorporated in the preamble instead of lines 14-15 of the claim.
16. Claim 7 is unclear in the following aspects:
(a) Claim 7 recites the plural antibiotics that were previously rejected in claim 1, i.e.: “Animoglycosides [sic], Polypeptides, fluoroquinolones, thioamides” (lines 3-4). The recitation of said plural antibiotics is inconsistent with the antibiotics recited in claim 1, as amended.
(b) Claim 7 depends from claim 1, and further limits the subgenus of antibiotics: “…[wherein] said antibiotic is selected from the group consisting of Isoniazid, Rifampicin, Ethambutol…” [emphasis added] which is redundant. Since claim 1 previously recites the Markush group of antibiotics, reciting the Markush again with a smaller number of species “selected from the group consisting of…” is superfluous. Instead, the claim should be further limited by reciting the following: “wherein the antibiotic is Isoniazid, Rifampicin, Ethambutol, etc”.
17. Claims 8 and 9 depend from claim 1, and further limit the subgenus of antibiotics: “…[wherein] said antibiotic is selected from the group consisting of Isoniazid, Rifampicin, Ethambutol…” [emphasis added] which is redundant. Since claim 1 previously recites the Markush group of antibiotics, reciting the Markush again with a smaller number of species “selected from the group consisting of…” is superfluous. The claims should be further limiting by reciting the following: “wherein the antibiotic is Isoniazid, Rifampicin, Ethambutol, etc”.
18. Claim 12 depends from claim 1, and recites additional antibiotics not previously recited in claim 1: “Kanamycin, Amikacin, Capreomycin, Viomycin, Streptomycin, Moxifloxacin, Levofloxacin, Ofloxacin, Gatifloxacin, Ethionamide, and Protionamide.” It is not clear if Applicant intends for the claim to embrace additional, unrecited antibiotics or if Applicant is expanding the scope of the claim by providing additional alternatives, which is not permitted.
It is recommended that claim be further limiting by reciting the following: “wherein the aminoglycoside antibiotic is Kanamycin, Amikacin, or Capreomycin; or wherein the polypeptide antibiotic is Viomycin or Streptomycin, etc”.
19. Claim 13 depends from claim 1 and recites the limitation "wherein the R10 is selected from the group consisting of…”. However, there is insufficient antecedent basis for this limitation in the claim, because a compound structure reciting the moiety R10 is not recited in claim 1.
Clarification is requested.
New Claim Rejections - 35 USC § 112(a)
20. 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.
21. Claims 1, 3, 5, 7-10, 12 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
22. The claim(s) contains 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In particular, support cannot be found for the full scope of acetyl-CoA carboxylase 2 (ACC2) inhibitors as instantly claimed.
23. The MPEP §2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus, i.e., “an inhibitor of the host acetyl-CoA carboxylase 2.” In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the Applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.”
24. In the instant case, it is evident that the genus of compounds embraced by “inhibitor of the host acetyl-CoA carboxylase 2” has substantial variance. The extremely broad genus of ACC2 inhibitors is virtually without limit, embracing hundreds of millions of potential compounds, including compounds according to the structure of formula I and compounds according to the structure of formula 2, which bear no structural resemblance to one another what-so-ever. For example, within formula II alone (recited in claim 3), Ar1 can be any of phenyl, pyridinyl, thienyl, furanyl, thiazolyl, and 1,3,4-thiadiazolyl; Ar2 can be thienyl, thiazolyl, isoxazolyl, 1,2,4-thiadiazolyl, and 1,2,4-oxadiazolyl; and Ar3 can be phenyl or pyridyl; which can be incorporated in hundreds of thousands of possible combinations, if not millions, with almost no structural overlap whatsoever.
25. The Specification teaches that the instant compounds are inhibitors of host acetyl CoA carboxylase 2 (ACC2), which are useful for treating a mycobacterial disease in a macrophage host cells of a host organism (page 1, lines 11-18). The Specification discloses the in vitro inhibitory activity of only approximately six ACC2 inhibitor compound species as recited in the claims, i.e., ab142090, CP640.186, MK-40474, ND-646, Diclofop, and Haloxyfop (see pages 37-41 and Figures 1-9). The instant Specification fails to disclose the preparation of any compositions comprising an ACC2 inhibitor and a recited antibiotic, or the administration of a composition comprising any ACC2 inhibitor compound species, including ab142090, CP640.186, MK-40474, ND-646, Diclofop, and Haloxyfop in combination with a recited antibiotic.
26. While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989). In the instant case, it is similarly determined that the instant disclosure does not adequately describe a subgenus embracing hundreds of millions of additional compound species bearing no structural relationship. That is, the Specification does not disclose a sufficient variety of species to reflect the extreme variance in the genus.
27. The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of ACC2 inhibitors recited in the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
As such, claims 1, 3, 5, 7-10, 12 and 13 are rejected.
28. Claims 1, 3, 5, 7-10, 12 and 13 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 a method of treating a mycobacterial disease in macrophage host cells of a host organism that is a mammalian subject in need thereof, wherein the mycobacterial disease is tuberculosis caused by Mycobacterium tuberculosis, comprising administering a composition comprising the ACC2 inhibitor ab142090, CP640.186, MK-40474, ND-646, Diclofop, or Haloxyfop, and at least one antibiotic selected from the group consisting of Isoniazid, Rifampicin, Ethambutol, Pyrazinamide, Rifapentine, Rifabutin, an aminoglycoside, a polypeptide, a fluoroquinolone, a thioamide, Cycloserine, Terizidone, Thioacetone, p- Aminosalicylic acid, Clofazimine, Linezolid, Amoxicillin, Clavulanate, Thioacetazone, Imipenem, Cilastatin, Clarithromycin, Delamanid, and Bedaquiline, is not considered enabled for treating said mycobacterial disease in macrophage host cells of a host organism comprising administering one of the above antibiotics and any ACC2 inhibitor(s), as presently recited. 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.
29. The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
30. These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons.
31. Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
In the instant case, the claims are drawn to a method of treating a mycobacterial disease in macrophage host cells of a host organism that is a mammalian subject in need thereof, wherein the mycobacterial disease is tuberculosis caused by Mycobacterium tuberculosis, comprising administering a composition comprising any ACC2 inhibitor and at least one antibiotic selected from the group consisting of Isoniazid, Rifampicin, Ethambutol, Pyrazinamide, Rifapentine, Rifabutin, an aminoglycoside, a polypeptide, a fluoroquinolone, a thioamide, Cycloserine, Terizidone, Thioacetone, p- Aminosalicylic acid, Clofazimine, Linezolid, Amoxicillin, Clavulanate, Thioacetazone, Imipenem, Cilastatin, Clarithromycin, Delamanid, and Bedaquiline, to said host organism in an amount effective to treat said mycobacterial disease.
32. The state of the prior art, level of predictability and relative skill level: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.”
As discussed above, the instantly claimed invention pertains to a method of treating a mycobacterial disease in macrophage host cells of a host organism that is a mammalian subject in need thereof, wherein the mycobacterial disease is tuberculosis caused by Mycobacterium tuberculosis, comprising: administering to the mammalian subject a composition comprising a therapeutically effective amount of any ACC2 inhibitor and at least one antibiotic selected from the group consisting of Isoniazid, Rifampicin, Ethambutol, Pyrazinamide, Rifapentine, Rifabutin, an aminoglycoside, a polypeptide, a fluoroquinolone, a thioamide, Cycloserine, Terizidone, Thioacetone, p- Aminosalicylic acid, Clofazimine, Linezolid, Amoxicillin, Clavulanate, Thioacetazone, Imipenem, Cilastatin, Clarithromycin, Delamanid, and Bedaquiline.
33. The relative skill of those in the art is high, that of an MD or PhD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, modifying even a single atom in a compound can dramatically change the compound’s overall structure and - even though complementarity in one portion of the compound might be improved by the chemical revision - the overall binding or activity might be severely compromised. This is certainly true in the case of ACC inhibitors which, as disclosed by Yeudall et al. (Sci. Adv. 8 (2022)) who discuss the role of ACC inhibition in NAFLD and cancer and teach the unpredictable outcomes of ACC inhibitors:
“Given its key role in the de novo synthesis of fatty acids, inhibition of ACC has become an attractive pharmacological target for nonalcoholic fatty liver disease (41, 42, 56, 57). Furthermore, ACC inhibitors are under investigation for treatment of solid malignancies including hepatocellular carcinoma (58) and non–small cell lung cancer (43). Our findings that (i) treatment with an ACC inhibitor attenuates inflammatory responses in vivo and (ii) macro-phages with decreased levels of ACC have a defect in pathogen killing in vitro suggest that attenuation of the immune response is a consequence of inhibition of ACC activity. Furthermore, our observation that treatment with a pharmacological inhibitor of ACC worsened outcomes in a model of peritoneal infection identified a role for ACC in in vivo pathogen control. The role of ACC in control of macrophage function that we identified could potentially be harnessed therapeutically in cases of hyperinflammation, such as seen, in patients with sepsis. However, our findings also point toward de-creased bacterial killing as a potential unwanted side effect of pharmacological ACC inhibition in the context of metabolic disease or cancer.” (page 12, right column, last paragraph- page 13, left column, first paragraph).
34. The state of the art regarding treatment of tuberculosis is that Mycobacterium tuberculosis is challenging to treat and uses “diverse strategies to survive in a variety of host lesions and to evade immune surveillance.” (Koul et al., Nature 2011, see abstract).
Koul et al. go on to teach that “MDR-TB [drug resistant tuberculosis” is resistant to at least isoniazid and rifampicin, the two most important first-line drugs used in the treatment of TB. This may result from either primary infection with drug-resistant bacteria or may develop in the course of a patient’s treatment when non-optimal treatment durations or regimens are used. Cure rates for MDR-TB are lower, typically ranging from 50% to 70%” (page 483, text box).
35. The amount of direction or guidance provided and the presence or absence of working examples: The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples. In the instant case, the specification provides no direction or guidance for the use of the full scope of the aforementioned ACC2 inhibitors in treating a mycobacterial disease in a host cell of a host organism in need thereof. The Specification discloses the in vitro inhibitory activity of only approximately six ACC2 inhibitor compound species as recited in the claims, i.e., ab142090, CP640.186, MK-40474, ND-646, Diclofop, and Haloxyfop (see pages 37-41 and Figures 1-9). The instant Specification fails to disclose the preparation of any composition(s) comprising an ACC2 inhibitor compound species, including ab142090, CP640.186, MK-40474, ND-646, Diclofop, and Haloxyfop, in combination with one of the recited antibiotics. No reasonably specific guidance is provided concerning useful therapeutic protocols for treating a host organism comprising administering a composition comprising any of the broad genus of ACC2 inhibitor compounds in combination with an antibiotic, other than an in vitro assay demonstrating the efficacy of the ACC2 inhibitors ab142090, CP640.186, MK-40474, ND-646, Diclofop, and Haloxyfop when combined with rifampicin or isoniazid (Figures 3 and 4).
36. The breadth of the claims: As stated in MPEP 2164.01(c), “[w]hen a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation.” Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled” (emphasis added). Indeed, the 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’.” In re Wright, 999 F.2d 1557 (Fed. Cir. 1993) (emphasis added). At the same time, however, it is also recognized that not everything necessary to practice the invention need be disclosed. Nor is it necessary that an Applicant test all the embodiments of his invention. In re Angstadt, 537 F.2d 498 (CCPA 1976) (emphasis added). In fact, as stated by the court in In re Buchner, 929 F.2d 660 (Fed. Cir. 1991), a patent need not teach, and preferably omits, what is well known in the art.
37. Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims." Amgen, Inc., v. Chugai Pharmaceutical Co., Ltd. (Fed. Cir. 1991). As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. See also Ak Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) and In re Moore, 439 F.2d 1232 (CCPA 1971). As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation”.
38. As to the first inquiry, as discussed above, it is evident that the genus of compounds embraced by “inhibitor of the host acetyl-CoA carboxylase 2” has substantial, if not extraordinary variance. The extremely broad genus of ACC2 inhibitors is virtually without limit, embracing hundreds of millions of potential compounds, including the entire subgenus of compounds according to the structure of formula I:
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284
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and the entire subgenus of compounds according to the structure of formula 2,
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which bear no structural resemblance to one another what-so-ever. For example, within formula II alone (recited in claim 3), Ar1 can be any of phenyl, pyridinyl, thienyl, furanyl, thiazolyl, and 1,3,4-thiadiazolyl; Ar2 can be thienyl, thiazolyl, isoxazolyl, 1,2,4-thiadiazolyl, and 1,2,4-oxadiazolyl; and Ar3 can be phenyl or pyridyl; which can be incorporated in hundreds of thousands of possible combinations, if not millions, with almost no structural overlap whatsoever.
39. The claims are thus very broad insofar as they are directed to the treatment of a disease caused by Mycobacterium tuberculosis in the macrophage host cell of a mammalian subject in need thereof, comprising: administering to the subject a therapeutically effective amount of a composition comprising any compound that is considered an ACC2 inhibitor in combination with at least one of the recited antibiotics. While such “treatment” might theoretically be possible utilizing ab142090, CP640.186, MK-40474, ND-646, Diclofop, and Haloxyfop in combination with rifampicin or isoniazid as delineated in Figures 3 and 4, as a practical matter it is nearly impossible to achieve treatment for said Mycobacterial disease with every possible alternative ACC2 inhibitor embraced by the instant claims.
40. Considering that the scope of said inhibitors encompasses hundreds of thousands of compound species, and potentially millions of compound species, it is evident that the claims are broad. Yet, as discussed above, the instant Specification discloses the efficacy of only two in vitro examples of ab142090 or CP640.186 in combination with rifampicin or isoniazid (Figures 3 and 4), but does not disclose the administration of any composition comprising an ACC2 inhibitor and an antibiotic to the macrophage host cell of a mammalian subject whatsoever. As such, the claim is extremely broad with respect to the disclosure. The second inquiry is discussed in detail below.
41. The amount of experimentation necessary: In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed. As discussed above, the claims are drawn to a method of treating a mycobacterial disease in macrophage host cells of a host organism that is a mammalian subject in need thereof, wherein the mycobacterial disease is tuberculosis caused by Mycobacterium tuberculosis, comprising: administering to the mammalian subject a composition comprising a therapeutically effective amount of any ACC2 inhibitor and at least one antibiotic selected from the group consisting of Isoniazid, Rifampicin, Ethambutol, Pyrazinamide, Rifapentine, Rifabutin, an aminoglycoside, a polypeptide, a fluoroquinolone, a thioamide, Cycloserine, Terizidone, Thioacetone, p- Aminosalicylic acid, Clofazimine, Linezolid, Amoxicillin, Clavulanate, Thioacetazone, Imipenem, Cilastatin, Clarithromycin, Delamanid, and Bedaquiline.
42. Since identifying any compound which is capable of modulating the activity of a specific receptor, ion channel, or enzyme is extremely complex, the nature of the instant invention considered to be one of extreme complexity. In the instant case, this complexity is exacerbated by the broadness of any ACC2 inhibitor with respect to the disclosure since the scope of said inhibitors encompasses hundreds of thousands of compound species, and potentially millions of compound species, whereas the instant Specification fails to disclose the administration of any such compound species exerting the disclosed activity. Although the relative skill of those in the art to which the invention pertains is high, the state of the art and unpredictability within the art is such that even the most talented artisan could not reasonably predict which of the hundreds of millions of compounds encompassed by the claims would exert the alleged activity based on the limited disclosure. Although the skilled artisan would have known that certain chemical modifications to the disclosed compounds may predictably provide structurally related compounds having similarly activity, the skilled artisan would have also known that even minor structural changes can, and frequently will, drastically alter or eradicate a parent compound’s ability to modulate the activity of a specific receptor or enzyme. As evidenced by Yeudell et al., above, ACC inhibitors, in particular, demonstrate significant unpredictability, and current treatment regimens of Mycobacterium tuberculosis present many challenges Thus, given the unpredictability of ACCs in particular, it is highly unpredictable whether any ACC2 inhibitor within the genus of compounds encompassed by the claims based on the instant disclosure would, in fact, be usable. Whether the other compounds encompassed by the claims would be usable is even less predictable. As such, the only way to ascertain which of the thousands, and potentially hundreds of thousands of claimed compounds presently encompassed by the claims are usable based on the limited disclosure would require undue experimentation. That is, the only way one skilled in the art is enabled to use the entire scope of the claim based on the instant disclosure entails undue experimentation.
To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure, i.e., limit the genus of ACC2 inhibitors to ab142090, CP640.186, MK-40474, ND-646, Diclofop, and Haloxyfop.
Claim Objections
43. Claim 1 is objected to for the recitation of the abbreviation “M. tuberculosis” in lines 12-13, since there was no previous recitation of “M. tuberculosis” in the claim, so employing the abbreviated term prior to the recitation of the full name “Mycobacterium tuberculosis” makes the claim inconsistent.
44. Claim 10 is objected to because the recitation of “wherein the mycobacterial disease is tuberculosis caused by…” in lines 2-3 is redundant. Claim 10 depends from claim 1, which recites the limitation “wherein the mycobacterial disease is tuberculosis” in lines 14-15; therefore, it is redundant to repeat the same limitation again. It is recommended that the limitation be replaced with: “wherein the tuberculosis is caused by…”, since it is already clear that said mycobacterial disease is the genus of tuberculosis.
45. Claim 12 is objected to because of the following informalities: a period is missing after the recitation of “claim 1” in line 1. Appropriate correction is required.
Conclusion
46. In conclusion, claims 1-5, and 7-13 are present in the application. Claims 2, 4 and 11 are currently withdrawn as directed to nonelected inventions. Claims 1, 3, 5, 7-10, 12 and 13 are rejected. No claim is presently allowable.
47. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached on Monday-Friday 8:30AM-5PM EST.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628