DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application is a 371 National Stage Entry of PCT/SG2022/050676 filed on September 21, 2022 which claims priority to foreign application No. SG10202110405X filed on September 21, 2021.
Status of Claims
Acknowledgement is made of original (1-6, 13-17), amended (9, 12), new (18-24), and canceled (7-8, 10-11) claims filed June 15, 2026. Claims 1-6, 13-17 are drawn to a non-elected species or invention and are withdrawn. Claims 9, 12, 18-24 are presently examined.
Restriction/Election
Applicant has elected Group II, claims 9, 12, drawn to a method of treating Mycobacterium abscessus infection. Applicant has submitted new claims 18-24 which appear to belong to Group II. Claims 1-6, 13-17 are withdrawn as being drawn to a non-elected invention.
Applicant has elected CAS# 1047734-46-2 as the species, which notably does not read on the instantly claimed genus (see below 35 U.S.C. 112(d) Rejection).
Following extensive search and examination, the originally elected species has been deemed free of the prior art with respect to the method claims.
Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Accordingly, Examination was extended to a non-elected species. Following extensive search and examination, the non-elected species was deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III), claims directed to other nonelected species have been withdrawn.
Information Disclosure Statement
The information disclosure statements filed on March 13, 2024 and August 6, 2025 have been considered except where lined through.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 recites “naphtyl” which appears to be a typographical error. It is assumed Applicant meant “naphthyl” as in claim 9.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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.
Claim 21 recites CAS# 1047734-46-2, which does not read on the genus of parent claim 9’s X-L-Y-Z.
CAS# 1047734-46-2
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CAS# 1047734-46-2 corresponds to instant Formula I wherein X is unsubstituted pyridyl, L is -CH2NHCOCH2CH2-, Y is unsubstituted benzimidazolyl, and Z is phenyl substituted with methyl. However, as shown above in the gray circle, the methylene of CAS# 1047734-46-2 is unaccounted for and is not embraced by the claimed structural limitations of Y or Z.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 9, 12, 18-20, 22-24 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. 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.
The claimed invention
Claims 9 and 12 are drawn to methods of treatment comprising administering a compound of instant Formula I shown below:
X-L-Y-Z
Formula I allows for a wide breadth of groups, with or without further substitution. The genus could amount to hundreds of distinct compounds across its full breadth given the independent variability across, and connectivity of, X, L, Y, and Z. Claims 18-20, 22-24 further limit the scope of Formula I, to a slightly narrower genus by narrowing only one variable (e.g. wherein X is pyridyl).
The supporting disclosure
One fully defined species not belonging to the genus of Formula I is disclosed (see instant spec. at Figure 13B, and p. 31 lines 5-7, “Ep1MabF1”, also known as CAS# 1047734-46-2) as a potent inhibitor of M. abscessus. Zero embodiments of the claimed invention of claims 9, 12, 19-20, 22-24 were reduced to practice wherein any type (e.g. in vitro, in vivo) of “bacterial infection caused by Mycobacterium abscessus” was successfully treated with any compound of Formula I via any route of administration at any amount at all.
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus (see, e.g., MPEP § 2163(II)(3)(a), MPEP §2163.03(V)). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. In this case, the claims encompass an essentially infinite number of methods of treating subjects having any possible “bacterial infection caused by Mycobacterium abscessus” by administering any one of numerous of compounds of claims 9 or 12, but zero embodiments of the claimed methods were actually reduced to practice wherein a specific “bacterial infection caused by Mycobacterium abscessus” was treated in a subject at any dosage at all. The courts have stated that “merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus” (see, e.g., AbbVie v. Janssen, 111 USPQ2d 1780 (Fed. Cir. 2014) at 1789).
Although the MPEP does not define what constitutes a sufficient number of representative species, the Courts have indicated that the disclosure of zero species within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618. Similarly, the disclosure of zero examples of the claimed invention does not provide sufficient disclosure to satisfy the written description requirement for the instantly claimed genus.
Applicant is attempting to claim something that the record does not evidence that they actually possess.
The state of the art
Although the level of skill in the art is high, the predictability in the clinical arts is low due to the complexity of biological systems, differences in patient populations, differences between species of “bacterial infection caused by Mycobacterium abscessus”. Specifically, an artisan would not be able to predict or identify, a priori, and in the absence of any guidance, the minimal, common structures, and amounts, of compounds capable of successfully “treating” different conditions of “bacterial infection caused by Mycobacterium abscessus”.
Accordingly, in the absence of sufficient structure/function teachings identifying an amount of any particular compound of Formula I for the successful treatment of any species of “bacterial infection caused by Mycobacterium abscessus” as required by the claims, an artisan would not reasonably conclude that Applicant possessed the full scope of the broad and highly varied genus of compounds or methods recited and encompassed by instant claims 9, 12 and dependent claims thereof.
Conclusion
An inventor need not "prove that a claimed pharmaceutical compound actually achieves a certain result. But when the inventor expressly claims that result, our case law provides that [such] result must be supported by adequate disclosure in the specification.” Biogen Int'l GmbH v. Mylan Pharm. Inc., 18 F.4th 1333, 1343 (Fed. Cir. 2021). Accordingly, the instant disclosure does not support the claims as written.
Claim Rejections - 35 USC § 112(a) Scope of Enablement
Claims 9, 12, 18-20, 22-24 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 treating an infection caused by Mycobacterium abscessus with CAS# 1047734-46-2, does not reasonably provide enablement for treating an infection caused by Mycobacterium abscessus with a compound of Formula I. 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.
To be enabling, the specification of the patent application 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, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the nature of the invention,
2- the breadth of the claims,
3- the state of the prior art,
4- the predictability of the art,
5- the amount of direction or guidance provided
6- the presence or absence of working examples,
7- the quantity of experimentation necessary, and
8- the relative skill of those in the art.
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). Undue experimentation is required by one skilled in the art to determine enablement of the instant disclosure as claimed due to the following:
The nature of the invention (1) and the breadth of the claims (2)
The nature of the invention and breadth of claim(s) 9, 12 is the treatment of an infection caused by Mycobacterium abscessus comprising administering a compound of instant Formula I shown below to a patient:
X-L-Y-Z
Formula I allows for a wide breadth of groups, with or without further substitution. The genus could amount to hundreds of distinct compounds across its full breadth given the independent variability across, and connectivity of, X, L, Y, and Z. Claims 19-20, 22-24 further limit the scope of Formula I, to a slightly narrower genus by narrowing only one variable (e.g. wherein X is pyridyl).
The instant specification defines “treatment” as therapeutic, palliative, or prophylactic (see instant spec. at p. 15 lines 22-25). The instant specification defines “patient” as mammalian (see instant spec. at p. 15 lines 27-30).
Furthermore, since subjects include mammals and treatment includes prophylaxis, the broadest reasonable interpretation includes a patient population of anyone.
The state (3) and predictability (4) of the art
MPEP § 2164.05(a) states if a publication demonstrates that those of ordinary skill in the art would not find that a particular invention was not enabled years after the filing date, the publication would be evidence that the claimed invention was not possible at the time of filing.
Regarding unpredictability of structure-activity relationships in treating Mycobacterium abscessus, Raynaud et. al.1 teaches benzimidazole derivatives for treating M. abscessus (see Raynaud at Title). Raynaud’s structures share a benzimidazole core (see Raynaud at p. 325 Table 1), a potential moiety for Y in instant Formula I, and a moiety also found in instant CAS# 1047734-46-2. Raynaud notes that despite sharing a benzimidazole core, the efficacy of the derivatives against M. abscessus range from no activity to high activity, indicating unpredictability in the structure-activity relationship of benzimidazoles against M. abscessus (see Raynaud at p. 326 right col. ¶2). Notably, Raynaud notes the N-1 nitrogen of the benzimidazole appears to be crucial for the efficacy of the compounds (see Raynaud at p. 326 right col. ¶3 and p. 325 Table 1), which instant CAS# 1047734-46-2 lacks due to its connectivity.
Applicant’s genus appears to be a departure from the state of the art in the structural motif, and done without any disclosed SAR methodology to support the distinction and the brevity of experimental results with just one compound that does not belong to the claimed genus. Applicant has not disclosed any rationale to support the breadth of the genus of instant Formula I as likely to function as a treatment for Mycobacterium abscessus.
The prior art provides enablement for treating Mycobacterium abscessus with some fully defined benzimidazole species comprising NH.
Examiner Note: while Raynaud indicates unpredictability in the art, Raynaud still renders obvious the instant application (see below 35 USC 103 rejection) because the modifications discussed to Raynaud Compound 3 CAS# 1378919-61-9 in the obviousness rejection do not alter the NH indicated by Raynaud essential to activity against M. abscessus based on. Based on the guidance and structure activity relationships provided by Raynaud (NH on benzimidazole is essential and present in CAS# 1378919-61-9), an artisan would reasonably expect the structural modifications discussed to not interfere with its known activity (Compound 3 MIC M. abscessus 64 ug/mL, see Raynaud at p. 325 Table 1).
The amount of direction or guidance provided (5) and the presence or absence of working examples (6)
The specification provides the following embodiments:
One fully defined species not belonging to the genus of Formula I is disclosed (see instant spec. at Figure 13B, and p. 31 lines 5-7, “Ep1MabF1”, also known as CAS# 1047734-46-2) as a potent inhibitor of M. abscessus.
The specification provides enablement for treating Mycobacterium abscessus with CAS# 1047734-46-2.
Zero embodiments of the claimed invention of claims 9, 12, 18-20, 22-24 were reduced to practice wherein any type (e.g. in vitro, in vivo) of “bacterial infection caused by Mycobacterium abscessus” was successfully treated with any compound of Formula I via any route of administration at any amount at all.
Therefore, the full scope of treatment in the methods of claim(s) 9, 12, 18-20, 22-24 are not enabled.
The quantity of experimentation necessary (7) and the relative skill of those in the art (8)
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. Because of the unknown predictability in the art (as discussed above) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that compounds of Formula I could be used as treatments for Mycobacterium abscessus.
Brenner v. Manson states "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and '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" (Brenner v. Manson 383 U.S. 519, 536, 148 USPQ 689, 696 (1966), cited in Genentech Inc. vs. Nova Nordisk 42 USPQ 2d 1001, Fed. Circuit 1997).
As noted above, little experimentation provided is drawn to treatment, prevention, and prophylaxis of infections caused by Mycobacterium abscessus. A review of the state of the art fails to reveal that any compound of instant Formula I would be useful as therapeutic treatment as claimed (e.g. inhibiting Mycobacterium abscessus). Determining if compounds of Formula I would be therapeutic for any particular disease state would require careful analysis and replicability of a composition comprising a compound of Formula I, formulation into a suitable dosage form, assay testing to correlate clinical efficacy, identifying off-targets, subjecting to animal trials, and subjecting to clinical trials.
All this is undue experimentation given the limited guidance and direction provided by Applicants.
Conclusion
Accordingly, the inventions of claims 9, 12, 18-20, 22-24 do not comply with the enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Suggested Amendment
Examiner suggests cancelling claims 9, 12, 18-20, 22-24 and amending claim 21 to be in proper independent form as a single species for treating an infection caused by M. abscessus.
Claim Rejections - 35 USC § 112(b)
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 9, 12, 18-19, 22-24 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.
Claims 9 and 12 recite “Y is a heteroaryl ring selected from…naphthyl” (note claim 12’s typo is “naphtyl”, see above Claim Objections). However, naphthalene is not a heteroaryl ring as it contains no heteroatoms.
Naphthalene
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Accordingly, the scope of Y is uncertain. Claims 18-19, 22-24 do not resolve the issue of indefnitineness and are thus included in instant rejection.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9, 12, 18-20, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Raynaud in view of Wermuth et. al.2
Regarding claims 9, 18-20, 24, Raynaud teaches compounds for treating Mycobacterium abscessus infections (see Raynaud at Abstract) such as CAS# 1378919-61-9 (see Raynaud at p. 325 Table 1 entry 3).
Raynaud Compound 3
CAS# 1378919-61-9
Instant Formula I
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X-L-Y-Z
CAS# 1378919-61-9 corresponds to instant Formula I when X is phenyl (compare with instant claims 18-19, 24), Y is benzimidazole (compare with claims 20).
The prior art differs from the instant claims as follows: While CAS# 1378919-61-9 X and Y moieties match instant Formula I, CAS# 1378919-61-9 L is CH2CH2 and Z is F, and the prior art does not specify a combination treatment.
However,
Regarding F for H, Wermuth teaches hydrogen and fluorine are isosteres, with fluorine mimicking hydrogen (see Wermuth at pp. 226-227).
Regarding a change of -CH2-, this is not a patentably distinct modification as discussed below.
Regarding claims 12, 24 and a combination, Raynaud teaches known treatments for Mycobacterium abscessus include antimicrobials and antitubercular drugs (see Raynaud at p. 325 right col. ¶2), such as a macrolides like clarithromycin or azithromycin or aminoglycosides like amikacin, or beta-lactams like cefoxitin or imipenem (see Raynaud at p. 326 left col. ¶1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding F for H, per MPEP § 2143(I)(B), a prima facie case of obviousness exists for simple substitution of one known element for another to obtain predictable results. It would have been obvious to a person of ordinary skill in the art to swap F (as taught by Raynaud) for H with a reasonable expectation of success because the known isosterism (as taught by Wermuth) would expect the modification to result in a functionally similar structure.
Regarding a change of -CH2-, per MPEP § 2144.09(I)-(II), “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities” because “[c]ompounds which are…homologs…are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties” (see, e.g., MPEP § 2144.09(I)-(II)), and the Court has stated that “[i]f a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR, 127 S.Ct. at 1740. In addition, per MPEP § 2144.08(II)(A)(4)(c), the closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. Here, the prior art teaches highly similar structural homologs of the instantly claimed invention, wherein such homologs have the same, exact utility as the instantly claimed Mycobacterium abscessus treatments; accordingly, an artisan would readily appreciate that such compounds could be utilized in the treatment of Mycobacterium abscessus, exactly as taught and suggested in view of the prior art.
Regarding a combination, per MPEP § 2144.06(I), "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been obvious to a person of ordinary skill in the art to combine two known treatments for Mycobacterium abscessus, such as a benzimidazole (as taught by Raynaud) and a macrolide or aminoglycosides or beta-lactam (as taught by Raynaud) because each composition would be performing its art-recognized function separately as they would together (treating a Mycobacterium abscessus infection).
Furthermore, it is well-within the ordinary skill in art to:
i) combine two known treatments for the same purpose as taught by the prior art,
ii) incorporate hydrogen in lieu of fluorine, and/or
iii) make and use a homolog of a known compound.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim(s) 9, 12, 18-19, 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Stular et. al.3 in view of Raynaud.
Regarding claims 9, 18-19, 23, Stular teaches inhibitors for treating Mycobacterium tuberculosis such as CAS# 1384750-43-9 (see Stular Supporting Info at Table S1 p. S3 entry 5, “ZINC76093424”).
Stular ZINC76093424
CAS# 1384750-43-9
Instant Formula I
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X-L-Y-Z
CAS# 1384750-43-9 corresponds to instant Formula I when X is pyridyl (compare with instant claims 18-19, 23), Y is benzofuranyl, and Z is H.
The prior art differs from the instant claims as follows: While CAS# 1384750-43-9 X, Y, and Z moieties match instant Formula I, CAS# 1384750-43-9 L is CH2NCH3COCH2CH2 and the prior art does not specify Mycobacterium abscessus or a combination treatment.
However,
Regarding claims 9, 12, 22 and a change of H for Me, this is not a patentably distinct change as discussed below.
Regarding all claims and Mycobacterium tuberculosis treatments for Mycobacterium abscessus, Raynaud teaches compounds with inhibitory activity against Mycobacterium tuberculosis are also effective against Mycobacterium abscessus (see Raynaud at p. 325 Table 1). Raynaud states, “[b]ecause M. tuberculosis and M. abscessus share many common biochemical pathways, it is likely that compounds inhibiting biosynthetic pathways in M. tuberculosis may also be active against M. abscessus” (see Raynaud at p. 326 left col. ¶2).
Regarding claims 12, 24 and a combination, Raynaud teaches known treatments for Mycobacterium abscessus include antimicrobials and antitubercular drugs (see Raynaud at p. 325 right col. ¶2), such as a macrolides like clarithromycin or azithromycin or aminoglycosides like amikacin, or beta-lactams like cefoxitin or imipenem (see Raynaud at p. 326 left col. ¶1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding a change of H for Me, per MPEP § 2144.08(II)(A)(4)(c), the closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. In addition or in the alternative, per MPEP § 2144.09(I)-(II), “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities” because “[c]ompounds which are…homologs…are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties” (see, e.g., MPEP § 2144.09(I)-(II)), and the Court has stated that “[i]f a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR, 127 S.Ct. at 1740. Here, the prior art teaches highly similar structural compounds differing only by methyl of the instantly claimed invention, wherein such compounds have the same, exact utility as the instantly claimed compounds; accordingly, an artisan would readily appreciate that such compounds could be utilized in the treatment of Mycobacterium infection, as taught and suggested in view of the prior art.
Regarding Mycobacterium tuberculosis treatments for Mycobacterium abscessus, per MPEP § 2143(I)(G) a prima facie case of obviousness exists for “some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.” The prior art suggests known treatments for M. tuberculosis will likely work on M. abscessus, accordingly an artisan would have a reasonable expectation of success when using a known M. tuberculosis treatment (as taught by Stular) to treat M. abscessus (as taught by Raynaud).
Regarding a combination, per MPEP § 2144.06(I), "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been obvious to a person of ordinary skill in the art to combine two known treatments for Mycobacterium abscessus, such as CAS# 1384750-43-9 (as taught by Stular) and a macrolide or aminoglycosides or beta-lactam (as taught by Raynaud) because each composition would be performing its art-recognized function separately as they would together (treating a Mycobacterium abscessus infection).
Furthermore, it is well-within the ordinary skill in art to:
i) incorporate H in lieu of methyl,
ii) use a known M. tuberculosis treatment for an M. abscessus infection, and/or
iii) combine two known treatments for the same purpose as taught by the prior art.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Allowable Subject Matter
If claim 21 was rewritten in independent form, as a method of treating a bacterial infection caused by Mycobacterium abscessus comprising administering a pharmaceutically effective amount of CAS# 1047734-46-2 (the structure of claim 21) to a patient in need, the claim would appear to be free of the prior art. While Group I is not presently examined, the Examiner notes that the compound CAS# 1047734-46-2 is not novel and not free of the prior art, and the corresponding compound claim would not be allowable.
Conclusion
Claims 9, 12, 18-24 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Raynaud et. al. "Active Benzimidazole Derivatives Targeting the MmpL3 Transporter in Mycobacterium abscessus" ACS Infect. Dis. 2020, 6, 2, 324–337. DOI: 10.1021/acsinfecdis.9b00389 Published December 9, 2019. Hereinafter Raynaud.
2 Wermuth, C. G. The Practice of Medicinal Chemistry "Chapter 13: Molecular Variations Based on Isosteric Replacements" Academic Press Limited, 1996, pp. 1-35. ISBN 0-12-744640-0. Hereinafter Wermuth.
3 Stular et. al. "Discovery of Mycobacterium tuberculosis InhA Inhibitors by Binding Sites Comparison and Ligands Prediction" J. Med. Chem. 2016, 59, 24, 11069–11078. DOI: 10.1021/acs.jmedchem.6b01277. Hereinafter Stular.
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