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 17/790,608
Claims 1-12 and 15-21 are currently pending.
Priority
Instant application 17/790,608, filed 7/1/2022, claims priority as follows:
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Receipt of the certified priority documents is acknowledged.
Information Disclosure Statement
All references from the IDS’s submitted on 7/1/2022 and 10/20/2023 have been considered unless marked with a strikethrough.
Response to Applicants Arguments/Amendments
The amendment filed 12/15/2025 has been entered. Claims 1 and 15 have been amended. Claims 13 and 14 have been cancelled. Claims 18-21 have been added, but are not considered new matter.
In the Non-Final Rejection dated 6/13/2025, claim 15 was rejected under 35 U.S.C. 112(b). In response, Applicant has amended instant claim 15 to include the term “useful”, which does not overcome the rejection. See the claim interpretation section below. Thus, the rejection has been maintained.
Claims 13-15 were rejected under 35 U.S.C. 112(d) in the Non-Final Rejection dated 6/13/2025. In response, claims 13 and 14 were cancelled, and claim 15 was amended. The rejections for claims 13 and 14 have been overcome and withdrawn. However, the amendment of claim 15 does not overcome the rejection, and it is maintained. The rejection has been updated to reflect the amendment in the claim.
In the Non-Final dated 6/13/2025, claims 1-9 and 11-15 were rejected under an Improper Markush rejection. Applicant’s arguments have been fully considered and found persuasive. Thus, the rejection is overcome and thus withdrawn.
Claims 1 and 10 were objected to in the Non-Final dated 6/13/2025. In response, claim 1 was amended to correct the minor informality to overcome and withdrawn the objection. Further, because claim 1 is allowed, the objection of claim 10 is now overcome and withdrawn.
The Examiner notes the addition of new claims 16-21 are also examined on the merits in this Office Action.
Election/Restriction
Applicant’s election of the compound N-((2-(3-Chloro-4-isopropoxyphenyl)pyrimidin-5-yl)methyl)-2-(1H-pyrazol-4-yl)-6-(trifluoromethyl)pyridine-4-amine (48):
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with traverse in the reply filed 5/28/2025 is acknowledged. The traversal is on the grounds that multiple species can be searched and examined together without undue burden. Additionally, considerable time and expense will be saved if all claims can be considered at this time, rather than pursuing multiple divisional applications. However, the instant application was filed under 35 U.S.C. 371, in which search burden is not a determining factor for restriction and election of species requirements but rather is determined by unity of invention. Thus, the election of species requirement is upheld and deemed final.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and no prior art was identified. The search was expanded to the full scope of the claims in accordance with Markush search practice, and no prior art was identified. However, additional issues were identified in the instant claims.
Claim Interpretation
Instant claim 15 recites, “A coating useful for medicinal devices containing at least one compound according to claim 1”, which is intended use of a compound of instant claim 1. The instant disclosure does not define what a coating is comprised of, other than a compound of instant claim 1, and it is not readily known to one of ordinary skill in the art. The compound recited in the instant claims is already considered capable of the intended use recited in claim 15, and is thus does not hold patentable weight.
MAINTAINED REJECTIONS
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.
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 15 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 15 recites, “a coating useful for medicinal devices containing at least one compound according to claim 1”. It is unclear what the coating for medicinal devices is comprised of, other than a compound of claim 1 (see 112(d) rejection below), and the limitation is not defined in the instant disclosure. Thus, the limitation is deemed indefinite. Appropriate correction is required. The Examiner notes this rejection can be overcome by amending the claim to recite, “A coating containing at least one compound according to claim 1.”
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.
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 15 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 from which it depends.
Claim 15 recites, “A coating useful for medicinal devices containing at least one compound according to claim 1”. However, in conjunction with the claim interpretation above, compound 1 is already considered capable of the intended use recited in claim 15. Thus, claim 15 is merely an intended use of the product already recited by claim 1 and is not given patentable weight. Accordingly, claim 15 fails to further limit claim 1.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
NEW OBJECTONS NECESSITATED BY AMENDMENT
Claim Objections
Claim 21 is objected to because it recites, “bacteriasl infection”, but should read, “bacterial infection”. Appropriate correction is required.
Close Prior Art
As stated in the Non-Final dated 6/13/2025, close prior art is Helmholtz-Zentrum Fur Infektionsforschung GMBH (WO 2020/007938 A1, cited in the IDS of 7/1/2022, herein after “Helmholtz”), which teaches inhibitors of PqsR, the only known receptor for the Pseudomonas Quinolone Signal (abstract). Helmholtz teaches compounds of formula (I):
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Where variable A is:
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And RA contains overlapping limitations with RA of the instant claims, A1 can be CH or N, A2 is N, and L and T contain overlapping limitations with the instant claims. Specifically, Helmholtz teaches compounds such as compound 108:
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Which solely differs from the elected species by the lack of heteroaromatic substituent, also defined as variable A of the instant claims, adjacent to the nitrogen on the pyridine ring (page 72, lines 7-9).
The genus of Helmholtz teaches that the variable A3, which maps to instant variable A, is allowed to be N or C-RA3, where RA3 represents a hydrogen atom, a halogen atom, CF3, CN, C(=O)NH2, C(=O)OH, CH2OH, CH2NH2, OH, OMe, or NH2. Because variable A of instant formula (I), in the same position as RA3, is solely allowed to be a 5- or 6-membered heteroaromatic group containing at least one nitrogen atom, this is the main difference between compounds of Helmholtz and compounds of the instant claims. There is no motivation, suggestion, or teaching of Helmholtz alone or in combination with the prior art to arrive at the instant claims.
Additional close prior art is Trius Therapeutics (WO 2008/098143 A2, cited in the IDS of 10/20/2023, herein after “Trius”). Trius teaches antimicrobial compounds and specifically teaches compound 5.35 (page 50, claim 11):
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Which partially maps to a compound of instant formula (I):
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when A is a 5-membered heteroaromatic group with at least one nitrogen atom and is substituted with a C1 alkyl group, L is L-2
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, where Y1 is NH, Y2 is NH, Y3 is H, and T is R, where R is H. However, compound 5.35 contains a pyrimidine core with a nitrogen at a different position than compounds of instant formula (I), and contains a chloro-methoxy-phenyl ether at the RA substitution site, which is not allowed by the instant claims. Further, though the compounds of Trius are known to have antimicrobial activity, the mechanism of action is by MetRS inhibition and thus differs from the mechanism of action of the compounds of the instant claims. Additionally, Gram-negative species are not tested in the antimicrobial assays of Trius. There is no motivation, suggestion, or teaching of Trius alone or in combination with the prior art to arrive at the instant claims.
Allowable Subject Matter
Claims 1-12 and 16-20 are allowed.
Conclusion
Claims 1-12 and 16-20 are allowed. Claim 15 is rejected. Claim 21 is 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 Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton 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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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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