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 .
DETAILED ACTION
This action is FINAL.
Status of Claims
Claims 1, 3, 4, 6, 8, 10, 12-15, 17, 19-25, and 30 are pending.
Claims 1, 3, 4, 6, 8, 10, 12-15, 17, 19 and 20 are examined.
Claims 21-25, and 30 are withdrawn (see restriction in the previous action).
Priority
This application is filed 02/28/2023 and claims the benefit of domestic priority as below:
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Information Disclosure Statement
One IDS(s) received 02/28/2023 have been considered unless marked with a strikethrough. No additional IDS(s) is/are provided.
Response to Arguments
Applicant's arguments/amendments filed on 6/30/2026, and in the amendments, claims 1, 4, 6, 8, 10, 13-14, 17, and 19 are amended; and claim 2, 5, 11, and 16 are cancelled. No new matter has been added. With respect to the objection of claims has been fully considered and are persuasive. Therefore, the previous objections of abstract, drawings and claims have been withdrawn. The Applicant's arguments of the rejection of 35 U.S.C 103 have been considered and are persuasive, because claim 1 now requires that the compound disrupt programmed ribosomal frameshifting (PRF) of a beta coronavirus, and previous rejection does not teach or obvious the newly added limitation as “the compound disrupts the programmed ribosomal frameshifting (PRF) of the RNA virus”. Therefore, the previous rejection of 35 U.S.C 103 has been withdrawn.
The Applicant's arguments for the rejection of 35 USC § 112 (a) as enablement and written description have been considered but are moot in view of the new ground of rejections for the amended claims 1, 4, 6, 8, 10, 13-14, 17, and 19. The previous rejections of record are withdrawn in view of the amendment.
New Ground of Rejections
Claim Interpretation
Claims are interpreted in accordance with the broadest reasonable interpretation (BRI) standard
consistent with the specification (See MPEP 2111).
Claim 1 defines ring A is
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, and further provides that “each occurrence of alkyl, alkoxy, alkenyl, cycloalkyl, aryl, and heteroaryl is independently optionally substituted”. Although the structure of ring A does not show a substituent attached to the ring nitrogen, the scope of Formula (I) would also be considered considering the specification. The specification identifies merafloxacin and other N1-subdtituented quinolone or fluroquinolone compounds as embodiments associated with Formula (I) (page 31-32). Thus, interpreting ring A’s nitrogen as necessarily limited to an unsubstituted nitrogen would exclude a compound that the specification identifies as an intended embodiment of Formula (I). (see MPEP 2111, and 2111.01) Accordingly, under BRI consistent with the specification, the nitrogen of ring A is interpreted as permitting substitution rather than being limited to unsubstituted nitrogen. The Examiner suggests that ring A be amended to make this limitation more accurate and clearer. For example, the relevant nitrogen may be depicted as NR, with R defined consistently with the corresponding substituents the same as Formula (II).
Claim Objections
Claim(s) 1, 12 and 20 is/are objected to because of the following informalities:
Claim 1 is objected to because “and” is duplicated in the R10 definition, and “optionally substituted;” should be ““optionally substituted; and”.
Claims 12 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
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.
Claim 19 is 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.
Claim 19 recites the limitation "The method of claim 16" in the first part. There is insufficient antecedent basis for this limitation in the claim. Claim 19 depends on canceled claim 16 and is therefore incomplete. (see MPEP 608.01(n)) For purposes of examination, claim 19 will be interpreted as depending from claim 13.
Claim Rejections - 35 USC § 112, Enablement
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, 3, 4, 6, 8, 10, 13-15, 17, and 19 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 experimental support for merafloxacin and certain related compounds shown in FIG 4, does not reasonably provide enablement for the full scope of compounds encompassed by Formula (I) and Formula (II) for treating, ameliorating, or preventing a beta coronavirus infection by disrupting PRF. 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.
This rejection is based on three related consideration of the enablement deficiency: (1) the breadth of the compounds encompassed by Formula (I) and Formula (II); (2) the breadth of the claimed beta coronavirus scope; and (3) a significant level of experimental validation is required in the absence of sufficient predictive guidelines because of the unpredictability of small molecule modulation of structured viral PRF elements.
To be enabling, the specification of the patent 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 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
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 the 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).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: 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.
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:
Nature of the invention:
The invention is drawn to a method of treating, ameliorating, or preventing a beta coronavirus infection using compounds of Formula (I), including compounds of Formula (II), wherein the compound disrupts PRF of the beta coronavirus. Thus, practicing the claimed method depends on the chemical structure and their PRF activity with respect to the beta coronavirus being treated.
Breadth of the claims:
Although amended claim 1 has been narrowed from RNA virus infections generally to beta coronavirus infections and Formula (I) has been further structurally limited, the claimed chemical genus remains broad. Formula (I) still permits alternatives at Y and R10, including hydrogen, deuterium, halogen, C1-C6 alkoxy, C1-C6 alkyl, C1-C6 alkenyl, C3-C6 cycloalkyl, C6-C12 aryl, and -C(=O)OR15, and combinations thereof, including optionally substituted embodiments, and further permits alternative ring configurations where m is 5 or 6. Formula (II) likewise contains multiple variable positions and alternatives substituents.
In addition, claim 1 requires the functional limitation as compound disrupts the programmed ribosomal frameshifting (PRF) of the beta coronavirus. The term, beta coronavirus is also broad, as it compasses a genus of viruses. The dependent claim identifies that the beta coronavirus is at least one selected from SARS-CoV, MERS-CoV, SARS-CoV-2, HCoV-OC43, and HCoV-HKU1. Plant et al. (Front Biosci. 13, 4873-8, pub’d 05/01/2008) describes PRF in coronavirus and the importance of structured RNA frameshift signals in coronavirus replication and supports that coronavirus PRF depends on structured RNA elements (abstract and programmed frameshifting section). Thus, beta coronaviruses and the identified coronaviruses cannot be regarded as a single genus operating via a unified mechanism. Therefore, it cannot be concluded and predicted that the full scope of Formula (I) or Formula (II) shows PRF activity across the broad spectrum of beta coronaviruses and the identified coronaviruses.
Level of ordinary skill in the art:
The artisans using applicant’s method would be a collaborative team of synthetic chemists, biologists, virologists, and/or pharmacologists having advanced skills and experience in antiviral drug discovery and RNA-small molecule interactions.
State of the prior art and predictability in the art:
Plant, as discussed above, describes PRF in coronaviruses and the dependence of coronavirus PRF on structured RNA frameshift signal (abstract and programmed frameshifting section). In addition, Warner et al. (Nature Reviews Drug Discovery, 2018, 17, 547–558, pub’d 07/06/2018) explains that there are inherent difficulties in predicting the activity of small molecules against RNA targets, because 1) it is challenging to identify suitable RNA target structures with drug-binding sites, and 2) only a very small number of RNA-binding small molecules are used clinically (abstract and the sections of provocative guidelines, and perspective). Thus, Waner supports that activity against a structured RNA target is not readily predictable merely from membership of a compound in a broad chemical class. Thus, Warner supports RNA small-molecule interactions depend entirely on high information content (i.e., chemical diversity and/or sequence-to-structure) and the specific tertiary or secondary structure of individual RNA pockets, rather than broad, predictable rules associated with standard protein-targeting scaffolds.
The specification also supports an unpredictability of small molecule modulation of structured RNA and PRF. The specification states that other tested fluoroquinolones in the compound library (FIG. 2A) and additional commercially available fluoroquinolones (FIGs. 3A and 3B) showed much lower frameshift inhibiting activities, suggesting that the varying moieties at N1, C7, and other positions play roles in the frameshift inhibition (page 59, lines 12-15), and shortening the distal sidechain while keeping the pyrrolidine (compound 1) reduced the anti-frameshifting activity (page 60, lines 28-32). Thus, the specification itself shows that structural similarity to merafloxacin does not reliably predict the degree of PRF activity and that relatively modest structural changes can materially affect activity.
Lastly, pharmacological activity of small molecules directed to coronavirus PRF is a very unpredictable area. In cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The amount of direction provided and working examples:
In the specification, merafloxacin and the nine analogs shown in FIG 4 provide working examples of specific compounds having anti-frameshifting activity. However, in view of breadth of the claims and unpredictability in the art as discussed above, the disclosed directions and working examples do not sufficient to determine the full scope of Formula (I) and (II) compounds will establish the required PRF activity in a broad beta coronavirus without additional experiments. The specifications do not provide structural correlation and/or other predictive guidelines.
Claim 10 additionally requires that the compound of Formula (I) enhance PRF. The inhibitory activity showed for merafloxacin and the related analogs does not itself provide guidance for identifying Formula (I) compounds having the specifically claimed PRF enhancing activity without experimental testing.
See MPEP 2164.02 (“Compliance with the enablement requirement of 35 USC 112, first paragraph, does not turn on whether an example is disclosed ... Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”).
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation to practice the full scope of claims. One of skill in the art would need to select, synthesize, or obtain compounds representing the numerous structural alternatives encompassed by Formula (I) and Formula (II), and experimentally determine whether those compounds disrupt PRF of the relevant bata coronavirus and provide the claimed therapeutic effect. Thus, the skilled artisan would need to make or obtain candidate compounds and empirically screen them for the claimed PRF function across the breadth of the claimed compound and beta coronavirus scope. In view of structure dependent activity and unpredictability taught by Plant, Warner, and the instant specification, the required experimentation would amount to substantial screening to identify operative embodiments rather than routine confirmation of embodiments.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but 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”.
Claim Rejections - 35 USC § 112, 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 1, 3, 4, 6, 8, 10, 13-15, 17, and 19 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP 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 applicants. (see MPEP 2163.02)
An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed.
Further, the MPEP states that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. (see MPEP 2161.01)
For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.") (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that "only similar language in the specification or original claims is necessary to satisfy the written description requirement").
As set forth in the en banc decision in Ariad Pharmaceuticals Inc. v. Eli Lilly and Company, 94 USPQ2d 1161 (Fed. Cir. 2010) at 1171, the court stated as follows:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. At 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. At 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 [25 USPQ2d 1601] (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
This rejection is based on the claimed functional genus of compounds within Formula (I) and (II) that possess the required beta coronavirus PRF disrupting activity.
With respect to claims 1, and 13, the claims recite “a compound of Formula (I), or a salt, solvate, isotopically labelled derivative, stereoisomer, or tautomer, and any mixtures thereof” and “the compound of Formula (I) is a compound of Formula (II) or a salt, solvate, isotopically labelled derivative, stereoisomer, tautomer, or geometric isomer thereof, and any mixtures thereof”. Claims 1 and 13 define a genus that includes (1) compounds of formula (I) or (II); (2) optionally substituted substituents; (3) multiple types of structural variation, including salts, solvates, isotopically labelled derivatives, stereoisomers, or tautomer; and (4) a functional requirement that the compound disrupts the programmed ribosomal frameshifting (PRF) of the beta coronavirus.
The specification provides experimental support for merafloxacin, and nine related compounds shown in FIG 4. However, these disclosed compounds represent only a limited portion of the broader structural scope encompassed by formulas (I) and (II). In particular, the disclosed compounds occupy only a limited region of the structural variation permitted by Formula (I) and (II) and do not represent the substantial alternatives permitted at the variable positions and substituents encompassed by the claimed genus.
The specification itself further provides materially different PRF activities among structurally related compounds. For example, other tested fluoroquinolones in the compound library (FIG. 2A) and additional commercially available fluoroquinolones (FIGs. 3A and 3B) showed much lower frameshift inhibiting activities, suggesting that the varying moieties at N1, C7, and other positions play roles in the frameshift inhibition (page 59, lines 12-15), and shortening the distal sidechain while keeping the pyrrolidine (compound 1) reduced the anti-frameshifting activity (page 60, lines 28-32). These results indicate that structural similarity within the broader chemical class does not, by itself, identify compounds possessing the claimed PRF disrupting function.
Further, in this specification, common structural characteristics of active compounds that distinguish between structurally related compounds having the necessary beta coronavirus PRF destruction function and structurally related compounds having no or substantially reduced PRF destruction activity are not disclosed. Therefore, the disclosed compounds do not reasonably represent the structural diversity of the claimed functional genus. Moreover, this specification discloses structure-function correlations that a person skilled in art would recognize as having been possessed by the inventors at the time of filing.
Consequently, the disclosed compounds do not constitute a sufficient number of representative compounds to demonstrate the structural diversity included in the claimed functional family. Furthermore, because this specification fails to disclose common structural features correlated with beta-coronavirus PRF inhibitory function, a person skilled in the art cannot reasonably understand that the inventors possessed the claimed functional family at the time of filing.
The limitations regarding beta coronaviruses do not address these deficiencies. Although the present specification presents PRF data for merafloxacin against several beta coronavirus PRF elements, such data primarily demonstrate the activity of merafloxacin itself. Therefore, this cannot be considered to reasonably support a broader category of structurally diverse compounds of Formulas (I) and (II) having the necessary PRF inhibitory function across the entire claimed range of beta coronaviruses, and the fact that merafloxacin has been proven to act on various beta coronavirus PRF elements does not establish that it possesses a broader category of structurally diverse compounds of Formulas (I) and (II) having such function.
Claims 3, 4, 6, 8, 10, 13-15, 17, and 19 depend directly or indirectly from claims 1 or 13, and thus, incorporate the functional genus deficiencies discussed above.
As set forth in the en banc decision in Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010), to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. Specifically, the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art in a way that shows that the inventor actually invented the claimed invention at the time of filing. Id.; Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172. (see MPEP 2161.01 and 2163). Herein, the instant specification discloses only a limited set of structurally related species and does not disclose structural features that identify representative species reflecting the structural diversity of the claimed genus or claimed functionally active members.
Accordingly, the specification discloses Formula (I), Formula (II), merafloxacin, and certain related compounds, but does not reasonably convey possession of the full scope of the presently claimed functional genus. While merafloxacin and nine specific compounds provide experimentally proven species within formulas (I) and (II), this specification does not provide a number of representative species reflecting the structural diversity allowed in the formulas, nor does it provide common structural characteristics sufficient to establish that the entire genera of formulas (I) and (II) compounds possess the necessary beta coronavirus PRF destruction function. Likewise, with respect to Claim 10, the specification does not specify structural features common to representative compounds of Formula (I) proven to enhance beta coronavirus PRF or compounds having the claimed PRF enhancing function. Therefore, the present disclosure does not reasonably represent the claimed functional series of compounds of Formulas (I) and (II) having PRF enhancing activity.
Conclusion
Claims 1, 3, 4, 6, 8, 10, 13-15, 17, and 19 are rejected.
Claims 1, 12, and 20 are objected to.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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