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 Claims
Claims 1,6-10,12-20 and 26-28 are pending in the instant application. Claim 17 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
An action on the merits of claims 1,6-10,12-16,18-20 and 26-28 is contained herein.
Information Disclosure Statement
The examiner has considered the information disclosure statement filed most recently of record.
Previous Objections/Rejections
Any rejections or objections stated of record in the office action mailed on 11/20/2025 that are not explicitly addressed herein below, are hereby withdrawn in light of applicant's arguments and/or amendments filed 3/20/2026.
Status of Rejections
35 USC § 112(a)
The rejection of claim 7 is maintained.
Applicant’s amendments and arguments, see Remarks, filed 3/20/2026, with respect to the rejection set forth in the Non-Final Office Action mailed 11/20/2025, have been fully considered but not found persuasive.
To reiterate the rejection of record, the skilled artisan would not have adequate reason to believe that Applicant had possession of the claimed “prodrugs” of formula I. No where does the specification allude to the specific identities of these structures. There are no working examples of these unknown prodrugs in the disclosure. Thus, how would one skilled in the art expect that Applicant was indeed of possession of the claimed prodrugs of formula I? Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p). Note also the following:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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The courts have applied this criteria in a more recent decision stating the following referencing genus claims drawn to chemical compounds:
“For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” see Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010).
Therefore, based on the lack of working examples; Applicants are not in possession of the claimed prodrugs.
The examiner notes that the “prodrug” language is still present in claim 7. Thus the rejection is maintained.
35 USC § 103
The rejection of claims 1,6,8-10,14,15,18,19, and 28 is maintained.
Applicant’s amendments and arguments, see Remarks, filed 3/20/2026, with respect to the rejection set forth in the Non-Final Office Action mailed 11/20/2025, have been fully considered but not found persuasive.
To reiterate the rejection of record, the instant claims may be drawn to the following compounds and compositions thereof:
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wherein the above compounds have the limitation where X = methylene, R5 = phenyl, and the methoxy group is at the ortho or para positions on the phenyl group.
Vergelli et al. teach the following compound and compositions thereof (see page 51, compound 4f, and page 58, cell culture information for compositions in original printed publication):
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. The compound differs from the claimed compounds in reference to the position of the methoxy group on the phenyl ring (meta vs. ortho or para). However the species are considered positional isomers.
MPEP states the following:
Compounds which are position isomers (compounds having the same radicals in
physically different positions on the same nucleus) or homologs (compounds differing
regularly by the successive addition of the same chemical group, e.g., by -CH2- groups)
are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Additionally the document teaches that the methoxy group may be present at any particular position on the phenyl ring (see generic structure 4a-f on page 51) and teaches positional isomers with respect to compounds 4a and 4b. Thus the claimed compounds would have been considered obvious.
Applicants suggest that since the claims have been limited with respect to variable R3 (believed to be now commensurate in scope with claim 11 that was not rejected under prior art); the rejection should be withdrawn. The examiner respectfully disagrees. The examiner clarifies that the scope of claim 11 and the currently amended claim 1 with respect to variable R3 are not identical. Note that the variable embraces the embodiment “aryl” which may be substituted with Z1. The prior art compound has the same limitation wherein variable R3 is aryl substituted with bromo (halogen) and other variables are defined previously Thus despite the amendment the prior art compound anticipates the claims and the rejection is maintained.
New Rejections
Claim Rejections - 35 USC § 112
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 7 and 26-27 are 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 7 does not further limit claim 1 with respect to the term “prodrug” since it was not recited in generic claim 1. Claims 26-27 recite chemical embodiments wherein one of variables A1-5 is selected from “N” (see compound 17 for example) which is not supported by claim 1.
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.
Conclusion
Claims 1,6-10,14-15,18-19, and 26-28 are rejected. Claims 12, 13, 16, and 20 are objected to. Note that full patentability of these claims have not been determined due to the search being limited to species having limitation wherein ring embracing A variables form a phenyl ring, Y1,2 = O, R2 = alkyl, and R3,4 selected from hydrogen, cycloalkyl, and phenyl and found prior art stated of record with respect to these species. See MPEP 803.02 regarding election of species practice “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, and need not be extended beyond a proper Markush grouping.”
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 BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
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