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
Status of the Claims
Claims 1-6, 8 and 11-17 are pending. Claims 1-2, 5, 8 and 11-17 are rejected. Claims 3-4 and 6 are objected to.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/EP2022/056588 filed 03/15/2022, which claims priority under 35 U.S.C. 119(a-d) to EP 21162835.9 filed 03/16/2021. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement (IDS) dated 05/29/2024 has been considered.
Claim Objections
Claim 13 is objected to because of the following informalities:
“teating” in the last line of the claim should be amended to “treating”.
Appropriate correction is required.
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.
Claims 11, 14 and 17 are rejected under 35 U.S.C. 112(b) being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 11, the parenthetical "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicant may overcome the rejection by amending the claim to delete: “(e.g. tuberculosis)”.
Regarding claims 14 and 17, drawn to a process for preparing the compound of Formula (II) and (I), respectively, the actual steps of the processes are unclear. It appears that Applicant intended the claims to recite step-wise processes, i.e. step (i) followed by step (ii) and so on given that step (ii) recites coupling of a compound “from step (i)”, for instance. However, in both claims, the formulae recited in step (ii) do not match the expected product resulting from the reaction of step (i). Per claim 17, the reaction of step (i) should result in synthesis of a target molecule, such as compound 7 shown on page 44 of the specification:
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. It is not clear where step (ii) fits in the overall schema of claims 14 and 17 since the specification appears to lack an example of a compound being prepared via that method.
Regarding claim 14, if Applicant intended for steps (i) and (ii) to represent two different methods of synthesizing target compounds, the claim should clearly indicate that, such as using “or” between the two processes.
Regarding claim 17, the same lack of clarity presented regarding claim 14 applies to steps (i) and (ii). Additionally, steps (iii) and (iv) appear to be required together for a third method of preparing target compounds. For instance, compound 1 was prepared, in part, according to steps (iii) and (iv). See page 34, and in particular the section outlined by the Examiner identifies the steps that correspond with (iii) and (iv) of claim 17:
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.
Applicant may cancel the claims or amend the claims to more clearly indicate whether and how the “steps” are performed, either in a step-wise fashion or as stand-alone processes.
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.
Claim 14 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 14, which depends from claim 2, is drawn to a process of preparing a compound of formula (II). Per claim 2, formula (II) has the structure
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. Claim 14, however, recites a process for making a compound of formula (II) using intermediates (XV) or (XVa) which have the structures
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. Since R6 is not limited to an isopropyl group in the dependent claim, claim 14 does not properly limit claim 2.
Applicant may overcome the rejection by, for example, amending the structures of (XV) and (XVa) such that R6 is an isopropyl group.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 5, 8, 11-13 and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8, 10, 14, 15, 18, 19, 21, 24, 25 and 27 of copending Application No. 17/639,963 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims disclose anticipatory subject matter.
Claim 27 of ‘963 discloses compound 226,
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, which is embraced by instant formula (I) of claim 1 wherein A is aromatic; X1 and X2 are each CH; R1 is Cl; R2 is CH3; R4 is C2H5; R5 is H; R6 is isopropyl. See also formula (II) of instant claim 2.
Claim 27 of application ‘963 also discloses compound 215,
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, which is embraced by instant formula (I) of claim 1 wherein A is aromatic; X1 and X2 are each CH; R1 is CH3; R2 is H; R4 is C2H5; R5 is H; R6 is methyl. See also formula (V) of instant claim 5.
Regarding instant claim 8, reference claim 10 is drawn to the same subject matter.
Regarding instant claim 12, reference claim 14 is drawn to the same subject matter.
Regarding instant claim 13, reference claim 15 is drawn to the same subject matter.
Regarding instant claims 15 and 16, reference claims 24 and 25 are drawn to the same subject matter.
Regarding instant claim 11, drawn to a method of treating a mycobacterial infection comprising administering a therapeutically effective amount of the compound of claim 1, the claims in reference application ‘963 do not explicitly claim the stated method.
With respect to the conflicting claims in reference application ‘963 being directed to a different statutory class of invention (instantly claimed method rather than the compound itself), the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. `
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
See also section 804 IIb of the M.P.E.P.
In the instant case, the specification in reference ‘963 identifies the utility of the compound to treat “bacterial diseases, particularly those disease caused by pathogenic bacteria such as Mycobacterium tuberculosis”. See, e.g., page 5, lines 24-25. The specification also demonstrates the inhibitory activity of, for instance, compounds 226 and 215 cited above against Mycobacterium tuberculosis in the biological data table beginning on page 210.
Since said utility of the compound as claimed in reference ‘963 is identical to the utility of the compound claimed in the instant claims, the claims in ‘963 render instant claim 11 unpatentable for anticipatory-type double patenting.
Thus, the instant claims are anticipated by the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 3-4 and 6 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.
The claims are free of the prior art.
The closest eligible prior art is from Kim et al. in WO 2015/014993, as cited in the IDS dated 05/29/2024.
Kim et al. teach compounds of formula
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“for their use in the treatment of bacterial infections, in particular tuberculosis” (see abstract and page 2). The compounds disclosed in the prior art have numerous differences from those included in the instant application, especially regarding this moiety:
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. Further, there is no suggestion or motivation to modify the prior art compounds in such a way as to identify the instantly claimed compounds, their uses, or processes of preparation.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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