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 .
Claim Status
Claims 1-10, 13-15, 18, 22, 27-28, and 32-34 are pending. Claims 27-28 and 32-34 are withdrawn as directed to a non-elected invention. Claims 2-5, 7, 9-10, 13-15, 18, and 22 are withdrawn as directed to non-elected species. Claims 1, 6 and 8 are presently considered.
Election/Restriction
Applicant’s election without traverse of Group I (original claims 1-10, 13-15, 18, and 22, directed to products) and the species, shown below, in the reply filed on 4/20/2026 was previously acknowledged.
The originally elected species was understood to be
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The elected species was understood to satisfy the requirements of Formula (I) at claim 1, which has the following structure:
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,
wherein R3 is understood to be the substituted cycloalkyl1 of 4-N-methyl-piperazinyl (
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); wherein R2 is a benzyl group, which is a C1 alkyl further substituted with a phenyl moiety (i.e., a benzyl group is an alkyl substituted with an aryl;
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); wherein R1 is an aryl and specifically a pyridinyl moiety (
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); and wherein A is
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and R16 is a C2 alkyl. Applicant failed to identify where in the originally filed disclosure the elected species was actually disclosed (i.e., by page, Example, or Figure number), and it the corresponding CAS Registration number is unknown. It is presently assumed Applicant made a proper species election by electing a single, disclosed species as required by the requirement, and that Applicant did not introduce new matter by electing a non-disclosed species.
Although Applicant identified that the originally elected species read upon instant claims 1, 6-8, and 18 (see, e.g., Reply filed 4/20/2026 at 2), this is incorrect because the species does not read upon claim 7 since it lacks an R3 that is either a “benzyloxy 4-N-methyl-piperazinyl” or otherwise a benzyloxycarbonyl moiety. Furthermore, no concentration was identified on record in connection to the originally elected species corresponding to “an effective amount to inhibit a cysteine protease” (i.e., it is unclear the originally elected species was tested at all, and it does not appear at Table 1), and, therefore, the elected species does not read upon claim 18. Accordingly, the originally elected species was understood to read upon instant claims 1, 6, and 8.
The originally elected species is understood to continue reading upon the amended claim scope filed 8/21/2026, wherein R1 is an aryl and specifically a pyridinyl moiety (
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); R2 is a benzyl group, which is a C1 alkyl further substituted with a phenyl moiety (i.e., a benzyl group is an alkyl substituted with an aryl;
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); R3 is understood to be the substituted cycloalkyl2 of 4-N-methyl-piperazinyl (
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); wherein A is
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; and R16 is a C2 alkyl. Notably, the amended “wherein” clause does not apply to the originally elected species because because R2 is a substituted alkyl; therefore the “wherein” clause proviso is not satisfied.
Following extensive search and examination, the originally elected species was deemed free of the prior art. 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 previously extended to a non-elected species of CAS Reg No: 438045-12-6. Following extensive search and examination, the non-elected species was deemed anticipated in view of the prior art as applied below. Per MPEP § 803.02(III), claims directed to other nonelected species have been withdrawn.
Critically, upon review, the amended claim scope is understood to continue reading upon the non-elected species of CAS Reg No: 438045-12-6, because the proviso of amended claim 1 does not apply, since the non-elected species comprises an R2 that is a benzyl moiety, which is a substituted alkyl, namely an aryl substituted C1 alkyl,
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). Accordingly, the proviso of the amended claim scope does not exclude the previously examined non-elected species, and the rejection is maintained below.
Claims 27-28 and 32-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/20/2026.
Claims 2-5, 7, 9-10, 13-15, 18, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/20/2026.
Accordingly, claims 1, 6, and 8 are presently considered.
Denial of Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications of US Provisional 63156198 (filed 3/03/2021); US Provisional 63156211 (filed 03/03/2021); and PCT/US2022/018714 (filed 03/03/2022) each fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163.
Lack of Express Support
Amended claim 1 is representative of the pending claim scope, but does not literally appears in the Pro’198, Pro’211, or PCT’714, and therefore the claims lack literal support in all priority documents. Specifically, the priority documents do not literally recite the genus at claim 1 limited by the new proviso added at the last three lines reciting “wherein when R3 is a cycloalkyl, and R2 is an aryl, then A is…..”.
Accordingly, the priority documents fails to provide literal support for the pending claim scope that is synonymous or equivalent in scope.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirement, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163. In the absence of express support, the relevant issue is whether or not the claimed invention is supported by Pro’231 through implicit or inherent disclosures.
Upon review, zero inherent or implicit support commensurate in scope with the metes and bounds of the instant claims is found in any priority document, at least because the priority documents do not inherently, implicitly, or literally teach, disclose, or identify a subgenus of compounds defined by equivalent or synonymous language as set forth at amended claim 1, at least because the priority documents fail to teach a genus limited by a proviso such as that found in amended claim 1 (e.g., “wherein when R3 is a cycloalkyl, and R2 is an aryl, then A is…..”.).
Accordingly, the priority documents fail to provide implicit or inherent support for the pending claim scope that synonymous or equivalent in scope, or otherwise commensurate in scope with the pending claims.
Conclusion
Accordingly, priority to US Provisional 63156198 (filed 3/03/2021); US Provisional 63156211 (filed 03/03/2021); and PCT/US2022/018714 (filed 03/03/2022) is denied for claim 1 and all of the dependents of claim 1; these claims have been accorded a priority date of 09/05/2023, which corresponds to the filing date of US Application No. 18/280,400. NOTE: At this time, newly available intervening art has not been searched, because prior rejections of record have been maintained, and examination has not unnecessarily been extended to other non-elected species.
Information Disclosure Statement
The IDS filed 8/21/2026 is acknowledged and presently considered.
Specification
The substitute specification filed 8/21/2026 is acknowledged.
Drawings
The drawings filed 8/21/2026 are acknowledged and accepted.
Withdrawn Claim Rejections
The rejection of claim 1 under 35 U.S.C. 102(a)(1) as being clearly anticipated by SCHEMBL11863658 (published in 2015; cited in IDS filed 9/05/2023 as cite No. 3), is withdrawn in view of the amendments to claim 1 as filed 8/21/2026.
Maintained Claim Rejections
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
[Rejection 01]
Claims 1, 6, and 8 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by WO2002/480973 (attached with appended CAS substance table, 10 pages).
Regarding instant claims 1, 6, and 8, WO’097 teaches and discloses compounds within the instant claim scope (see, e.g., WO’097 at claims 1, 7, 13, 33, and 35-38), including at least the following two compounds:
1.N-(N-(4-methylpiperazinylcarbonyl)phenylalanyl) tyrosinal (i.e., [4-metylpiperazine]-C(=O)-[Phenylalanine-[Tyrosinal], wherein Tryrosinal is Tyr-H where the carboxylic acid (COOH) is reduced to an aldehyde (CHO)) (see, e.g., WO’097 at claim 13 at page 82). This claimed compound corresponds to substance “47” and CAS No. 438045-11-5 in the Substance Table, which identifies that the compound may alternatively be called 1-Piperazinecarboxamide, N-[(1S)-2-[[(1S)-1-formyl-2-(4-hydroxyphenyl)ethyl]amino]-2-oxo-1-(phenylmethyl)ethyl]-4-methyl-N-(N-(4-methylpiperazinylcarbonyl)phenylalanyl)tyrosinal, and that the compound has the chemical structure of
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This chemical structure satisfies the requirements of instant claims 1, 6, and 8 wherein R1 is a substituted aryl, R2 is a benzyl moiety (an aryl substituted C1 alkyl), A is
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, and R3 is a 4N-alkyl-piperazinyl moiety (see, e.g., WO’097 at Substance Table at Compound 47, claim 13).
(S)-2-(N-(4-methylpiperazinylcarbonyl)phenylalanyl)amino-4-phenylbutanal, (i.e., ) (see, e.g., WO’097 at claim 13 at page 82). This compound corresponds to Substance Table Compound “48” and CAS NO: 438045-12-6 in the Appended Substance Table, which identifies that the compound may alternatively be called 1-Piperazinecarboxamide, N-[(1S)-2-[[(1S)-1-formyl-3-phenylpropyl]amino]-2-oxo-1-(phenylmethyl)ethyl]-4-methyl-(S)-2-(N-(4-methylpiperazinylcarbonyl)phenylalanyl)amino-4-phenylbutanal (see, e.g., WO’097 at Substance Table at Compound 48, claim 13), and the compound has the chemical structure of
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This chemical structure satisfies the requirements of instant claims 1, 6, and 8 wherein R1 is a aryl-substituted alkyl, R2 is a benzyl moiety (an aryl substituted C1 alkyl), A is
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, and R3 is a 4N-alkyl-piperazinyl moiety (see, e.g., WO’097 at Substance Table at Compound 48, claim 13).
Furthermore, formulations and applications of such compounds were known and claimed in the prior art (see, e.g., WO’097 at claims 1, 7, 13, 33, and 35-38).
Accordingly, claims 1, 6, and 8 are clearly anticipated by the prior art.
[Rejection 02]
Claims 1, 6, and 8 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Lee et al.4.
Regarding instant claims 1, 6, and 8, Lee discloses the compound of “4-Methylpiperazinyl-CO-Phe-hPhe-al”, wherein “al” is understood to be aldehyde (-CHO), as Compound 9052 (see, e.g., Lee at Table 1 on 3811). This compound is understood to have the following chemical structure5:
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(see, e.g., Lee at Table 1 on 3811). This structure satisfies the requirements of instant claims 1, 6, and 8, wherein R1 is an aryl-substituted alkyl, R2 is a benzyl moiety (an aryl substituted C1 alkyl), A is
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, and R3 is a 4N-alkyl-piperazinyl moiety (compare Compound 9052 at Lee at Table 1 on 3811 with instant claims 1, 6, and 8). In addition, in view of Table 1, an artisan would readily appreciate that the tested compounds were necessarily and inherently utilized in purified form in pharmaceutical assays requiring pharmaceutical compositions wherein the compound was present in an amount effective for obtaining an IC50 value.
Accordingly, claims 1, 6, and 8 are anticipated by the prior art.
New Claim Rejections Necessitated by Applicant Amendment
Claim Rejections - 35 USC § 112(a), New Matter
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, 6, and 8 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.
Applicable Case Law
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163.
Regarding narrowing amendments attempting to carve a narrower genus from a broad and highly varied genus and laundry list disclosure, the case law and MPEP guidance states, per MPEP § 2163.05(II), that
The introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) . . . . ; Rozbicki v. Chiang, 590 Fed.App’x 990, 996 (Fed. Cir. 2014) (non-precedential) (The court found that patentee, "while attempting to obtain the broadest claim language possible during prosecution, cannot now improperly narrow its language by importing limitations not supported by the claim language or written description."). In Ex parte Ohshiro, 14 USPQ2d 1750 (Bd. Pat. App. & Inter. 1989) . . . .
This courts have clearly stated that the mere disclosure of “each ... individual limitations” separately and distinctly, does not evidence possession of all combinations of all such limitations “as an integrated whole” because written description support requires more than the combination of “an amalgam of disclosures plucked selectively from the ... application” (see, e.g., Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1349, 107 U.S.P.Q.2d 1457, 1467, 2013 BL 192990, 14 (Fed. Cir. 2013), explaining that the written description analysis requires “[t]aking each claim . . . as an integrated whole rather than as a collection of independent limitations”).
Lack of literal Support
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163.
Amended claim 1, as filed 8/21/2026, does not literally appear in the originally filed disclosure, because the proviso added at the last three lines reciting “wherein when R3 is a cycloalkyl, and R2 is an aryl, then A is…..” does not literally appear in the originally filed disclosure.
Accordingly, the pending claims, having the equivalent or synonymous scope instantly claimed, do not literally or inherently appear in the originally filed disclosure.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163. As noted above, the claims are not literally or inherently supported by the originally filed disclosure. Accordingly, the relevant issue is whether or not the new amendments and resulting claim scope is implicitly or inherently supported by the originally filed disclosure.
Per MPEP § 2163(I)(B), “[a]n amendment to correct an obvious error does not constitute new matter where the ordinary artisan would not only recognize the existence of the error in the specification, but also recognize the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971)”. Here, no allegation that the amendments correct an obvious error has been made. Furthermore, upon inspection, Examiner is unable to identify any single “obvious error” that would lead to instantly amended claim 1 and the scope thereof. Accordingly, the amendments cannot be said to correct an “obvious error”, but instead the amendments attempt to circumvent the prior art by adding a proviso that does not literally appear in the originally filed disclosure.
No implicit or inherent support directing an artisan to dismiss the broader genus described on record, and pick and choose limitations, in a manner to arrive at the instantly claimed subgenus, has been found on record.
Accordingly, no implicit or inherent support for the amended claim scope using synonymous or equivalent language has been found in the originally filed disclosure.
Consideration of Alleged Supporting Disclosures
In the Reply filed 8/21/2026, Applicant fails to identify any citations, page numbers, or other form of support corresponding to the amended claim scope, but instead merely recites, without evidence, that “No new matter is added by way of these amendments” (see, e.g., Reply filed 8/21/2026 at 12 at 5th ¶). Critically, this fails to satisfy the requirements of MPEP § 714.02, which states that “Applicant should also specifically point out the support for any amendments made to the disclosure. See MPEP § 2163.06”.
Accordingly, no literal, inherent, or implicit support for the amended claim scope appears on record, and Applicant failed to specifically point out any support for the amendments made to the pending claims.
Conclusion
Per MPEP § 2163, new or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement (see, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971)). Here, the newly added claim limitations result in a narrower claim genus which defines a novel subgenus of species that was not inherently, implicitly, or literally supported by the originally filed disclosure.
“A written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention” (see Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., 18 F.4th 1323, 1329 (Fed. Cir. 2021). Although the originally-filed disclosure may render the instant claims obvious, “a description which renders obvious a claimed invention is not sufficient to satisfy the written description requirement of that invention” (see, Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1567 (Fed. Cir. 1997)) because “[o]ne shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious” (Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997) at 1572).
Accordingly, claims 1, 6, and 8 are rejected.
Response to Arguments
Applicant's arguments filed 8/21/2026 have been fully considered but they are not persuasive.
It is the Examiner’s understanding that Applicant addresses all rejections of record, jointly, at pages 13-14 of the Reply (see, e.g., Reply filed 8/21/2026 at 13 at § “Rejections” to page 14 at penultimate ¶), and recites that claim 1 was amended (see id), and alleges that “Lim-Wilby, Lee, and SCHMBL” do not disclose or suggest a compound of Formula I, as claimed” (see id). Applicant does not further elaborate or explain specifically how these amendments exclude the prior art embodiments.
Upon review, Applicant’s arguments and position have been fully considered but not found persuasive. Presumably, Applicant believed that the proviso of amended claim 1 excluded the art of record, but this is incorrect because the proviso does not apply when R2 is a substituted alkyl.
Here, the compound of Lee has an R1 that is an aryl-substituted alkyl, R2 is a benzyl moiety (i.e., an aryl-substituted C1 alkyl), A is
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, and R3 is a 4N-alkyl-piperazinyl moiety (compare Compound 9052 at Lee at Table 1 on 3811 with instant claims 1, 6, and 8). Therefore, the added proviso is inapplicable to the compound of Lee. Similarly, the compounds of WO2002/48097 also each comprise a compound having an R2 that is a benzyl moiety (an aryl substituted C1 alkyl), and therefore the proviso is not applicable to the substituted alkyl. Accordingly, the amended claim scope continues to read upon the art of record.
Accordingly, all arguments raised by the Applicant have been fully considered but not found persuasive, and therefore the claims are not allowable. All new rejections were necessitated by Applicant’s amendments.
Applicant is advised that in view of the denial of priority, additional art may be applicable to the pending claim scope, but examination has not been extended unnecessarily to cover all nonelected species, or beyond the non-elected species set forth above under 35 USC 102.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US202303019886 (corresponding to abandoned Application 18/023,661; Notice of abandonment mailed 4/27/2026) pertains to highly similar compounds to those presently claimed. The prosecution history and art therein is relevant to the instant application.
Examiner Notes
To facilitate compact prosecution, if Applicant amends the claims to recite the originally elected species directly, Applicant should clearly identify all supporting disclosure(s) to such species present in the originally filed disclosure and priority documents.
Examiner assumes the species election was properly performed by Applicant (i.e., that a single, disclosed species was properly elected as required by the Requirement mailed 2/18/2026). However, following review, the Examiner was unable to find unambiguous support in the original disclosure for this exact species. In the absence of clear support, Applicant is advised that in the absence of identification, a subsequent amendment attempting to specifically claim this exact species may necessitate a rejection under 35 USC §112 and/or alter the applicable priority.
Conclusion
No claims are allowed.
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 RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 The 4-N-methyl-piperazinyl was identified in the Response to Requirement filed 4/20/2026 as a heteroaryl of 4-N-methyl-piperazinyl, which is understood to be an error, as this substituent is understood to be a substituted cycloalkyl, wherein “substitutions” include substitutions of carbons with nitrogen (see, e.g., Spec. filed 9/05/2023 at 16 at 2nd and 3rd full ¶¶, 16-17 at bridging ¶, 17 at 1st full ¶ to 18 at 1st partial ¶, 20 at 1st full ¶, dependent claim 6).
2 The 4-N-methyl-piperazinyl was identified in the Response to Requirement filed 4/20/2026 as a heteroaryl of 4-N-methyl-piperazinyl, which is understood to be an error, as this substituent is understood to be a substituted cycloalkyl, wherein “substitutions” include substitutions of carbons with nitrogen (see, e.g., Spec. filed 9/05/2023 at 16 at 2nd and 3rd full ¶¶, 16-17 at bridging ¶, 17 at 1st full ¶ to 18 at 1st partial ¶, 20 at 1st full ¶, dependent claim 6).
3 Cited in previous action.
4 Lee et al, 2003. Antimalarial Activities of Novel Synthetic Cysteine Protease Inhibitors. Antimicrob Agents Chemother 47, https://doi.org/10.1128/aac.47.12.3810-3814.2003; hereafter “Lee”; cited in previous action.
5 Examiner notes that this corresponds to the attached Search notes identifying references associated with CAS NO: 438045-12-6.
6 Cited in previous action.
Prosecution Insights