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
This application, filed 7 October, 2020, is a national stage application of PCT/US2021/026691, filed 9 April, 2021, which claims the benefit of U.S. provisional application 63/007,847, filed 9 April, 2020.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 16 December, 2025, in the matter of Application N° 17/995,806. Said documents have been entered on the record.
Claims 17-19 are amended. Claim 27 is canceled. No new matter was introduced.
Thus, Claims 1-3, 11, 14-22, 24 and 28-31 represent all claims currently under consideration.
Response to Amendment/Arguments
Claim 27 has been canceled. Therefore, the rejections of this claim under 35 U.S.C. 103 is moot.
Applicant’s amendment is sufficient to overcome the rejection of Claims 17-19 under 35 U.S.C. 102(a)(1) and 103.
Below can be found new grounds of rejection necessitated by amendments.
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 17 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 17 has been amended such that Z1 is limited to N; however, the claim continues to define Ra and further recites an alternative definition of R1 applicable “when Z1 is CRa.” Because Z1 is no longer permitted to be CRa, it is unclear what scope, if any, is imparted by these remaining limitations. Accordingly, the scope of Claim 17 is rendered unclear.
The following amendments would overcome this rejection:
At Z1, delete “, wherein Ra is H, halo, hydroxy, alkyl, alkoxy, aryl, amino, acyl or C(O)Rb, wherein Rb is alkyl, aryl, OH or alkoxy”
At the first R1, delete “Rl is hydroxyalkyl, aminoalkyl, -S(O)xalkyl (wherein x is 0, 1 or 2), -carboxylalkyl, -thiocarboxyl, -thiocarboxylalkyl, amido or -amidoalkyl when Z1 is CRa; or”
At the second R1, delete “when Z1 is N”
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.
Claim 22 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 22 depends from Claim 17, which requires Z1 to be N, but expressly recites species wherein the atom at the position corresponding to Z1 is carbon rather than nitrogen. Such species therefore do not incorporate all limitation of parent Claim 17 and fall outside the scope thereof. Deletion of the species wherein Z1 is not N, which are Structures 7 (Pg 10, 4th Row, 1st Structure) and 9-12 (Pg 11, 1st four structures) would overcome this rejection.
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 § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (US 2016/0168118 A1, of previous record), and further in view of Meanwell (Top Med Chem. 2015. 9: 283–382).
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Zhu teaches compound 5 (‘118, Pg. 7, Table 1), shown right, which is fully encompassed by instant Formula I, wherein Z1 is -CRa, wherein Ra is H, R1 is an aminoalkyl, R2 is F, and R3 is F.
Zhu fails to teach Z1 is N, as currently amended.
However, Meanwell teaches the strategic introduction of a nitrogen atom into an aromatic ring as a known bioisosteric modification in medicinal chemistry and teaches that such aza substitution may advantageously alter the electronic and metabolic properties of the aromatic ring, including reducing susceptibility to oxidative metabolism (2015, Pg 353, Para 1).
It would therefore have been prima facie obvious to one of ordinary skill in the art at the time of the invention to modify the aromatic ring of Zhu compound 5 by replacing the carbon atom bearing hydrogen at the position corresponding to Z1 with nitrogen, as taught by Meanwell, in order to obtain an aza analog having modified and potentially improved metabolic properties. One of ordinary skill would have had a reasonable expectation of success because Meanwell teaches aza substitution of an aromatic ring as a known medicinal-chemistry strategy and demonstrates successful use of such substitution to alter the metabolic behavior of an otherwise corresponding aromatic compound.
Allowable Subject Matter
Claims 1-3, 11, 14-16, 24 and 28-31 are allowed.
Claims 20-21 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.
As previously stated, the allowable claims are directed to a conjugate compound comprising a specific arrangement of functional components covalently linked in a defined structural relationship. While the prior art of record (WO 2011/082285 A1, WO 2018/111989 A1, and US 2016/0168118 A1 – Zhu, all cited in an IDS, and referenced in the ISR), generally described aspects of the relevant chemical and biological art, none of the references, alone or in combination, disclose or suggest the claimed conjugates as a whole, nor do they teach or render obvious the particular manner in which the recited components are linked together in the instant claims. The prior art instead describes the individual components or related systems in isolation or in different structural contexts. Accordingly, the claimed subject matter represents a patentably distinct conjugate over the art of record.
Conclusion
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.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
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