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
Instant application 18/294,248 filed on 02/01/2024 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
The amendment filled on 05/15/2026 has been entered.
Claims 12-16, 19-20, 29, 32, 43, 52, 62, 63 and 65-69 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/18/2026, 05/30/2025 and 04/16/2024 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 05/15/2026 is acknowledged.
Claims 32, 43, 52, 62, 63 and 67-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/15/2026.
Regarding species election, Applicant’s election of
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without traverse in the reply filed on 05/15/2026 is acknowledged.
Claims 16, 20 and 65 read on the elected species.
Examination will begin with the elected species. In accordance with the 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 reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Species Election
A careful review of the prior art has indicated that elected species is free of the prior art. A claim directed to the elected species in independent form would be free of the prior art.
The examiner has moved onto alternative species embodied within the general Formula (V). The search was expended to the whole scope of claim 16. Since no art has been identified, examiner has moved onto alternative species embodied within the general formula (IV), and subsequent examination is based on this species expansion.
The expended species is:
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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.
Claims 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN (RN# 2119577-41-4, entered to STN 05 Jun 2020).
STN teaches:
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The above compound falls under instant Formula (IV) wherein R5 is NH2, q is 1, R1 is Cl and n is 2. It should be noted that the above compound is recited in instant claim 14.
MPEP 2128(I)B states “Electronic publications on the internet or on an online database are considered to be publicly available as of the date the item was publicly posted.”
In the instant case, the compound was available in STN on 06/05/2025.
Since the above compound meets all the limitation of instant claims, the instant claims are anticipated.
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 following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over STN (RN# 2119577-41-4, entered to STN 05 Jun 2020).
STN teaches:
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The above compound falls under instant Formula (IV) wherein R5 is NH2, q is 1, R1 is Cl and n is 2.
STN teaches racemic mixture; STN does not teach the specific stereoisomers recited in instant claim 15.
However, a person of ordinary skill would be capable of isolating stereoisomers of a known compound in stereochemically pure form. The skilled artisan would have been motivated to test and compare properties of each isomer.
See also MPEP 2143, Example 8. The MPEP states:
“In Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007), the claims were drawn to the 5(S) stereoisomer of the blood pressure drug ramipril in stereochemically pure form, and to compositions and methods requiring 5(S) ramipril. The 5(S) stereoisomer is one in which all five stereocenters in the ramipril molecule are in the S rather than the R configuration. A mixture of various stereoisomers including 5(S) ramipril had been taught by the prior art. The question before the court was whether the purified single stereoisomer would have been obvious over the known mixture of stereoisomers.
The record showed that the presence of multiple S stereocenters in drugs similar to ramipril was known to be associated with enhanced therapeutic efficacy. For example, when all of the stereocenters were in the S form in the related drug enalapril (SSS enalapril) as compared with only two stereocenters in the S form (SSR enalapril), the therapeutic potency was 700 times as great. There was also evidence to indicate that conventional methods could be used to separate the various stereoisomers of ramipril.
The district court saw the issue as a close case, because, in its view, there was no clear motivation in the prior art to isolate 5(S) ramipril. However, the Federal Circuit disagreed, and found that the claims would have been obvious. The Federal Circuit cautioned that requiring such a clearly stated motivation in the prior art to isolate 5(S) ramipril ran counter to the Supreme Court’s decision in KSR, and the court stated: Requiring an explicit teaching to purify the 5(S) stereoisomer from a mixture in which it is the active ingredient is precisely the sort of rigid application of the TSM test that was criticized in KSR.
Id. at 1301, 84 USPQ2d at 1204. The Aventis court also relied on the settled principle that in chemical cases, structural similarity can provide the necessary reason to modify prior art teachings. The Federal Circuit also addressed the kind of teaching that would be sufficient in the absence of an explicitly stated prior art-based motivation, explaining that an expectation of similar properties in light of the prior art can be sufficient, even without an explicit teaching that the compound will have a particular utility.”
Allowable Subject Matter
Claims 16, 19, 20, 29,65 and 66 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The closes prior art is as follows:
Fernandes (Fernandes AS e al., Front. Microbiol. 12:603700, published 01 March 2021) teaches targeting components of the K+ homeostasis machinery has the potential as a new antibacterial strategy (see abstract).
Fernandes teaches compound 41(see Table 1, page 7):
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However, compound 41 of Fernandes differs from compounds of instant formula (V):
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wherein, R1 is Cl, in R5 position.
It should be noted that instant claim 16 recites Formula (V) wherein R5 is limited to NRARB or imidazolyl. Compound 41 bears CH3 group in a position corresponding to instant R5 variable.
Without a teaching or suggestion from prior art a person of ordinary skill in the art would not have been motivated to modify the compounds of Fernandes to arrive at the instant compounds with a reasonable expectation of success.
Further, STN 1797868-00-8 teaches:
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However, compound STN 1797868-00-8 differs from compounds of instant formula (V) wherein R5 is imidazolyl, in R1 position.
It should be noted that instant claim 16 recites Formula (V) wherein R1 is limited to Cl or fluoroalkyl. Compound STN 1797868-00-8 bears Cl and CH3 substituents in positions corresponding to instant R1 variable.
Without a teaching or suggestion from prior art a person of ordinary skill in the art would not have been motivated to substitute CH3 group for fluoroalkyl to arrive at the instant compounds with a reasonable expectation of success.
Furthermore, Vaisburg (US-2019/0100493-A1) teaches (see page 18, right column):
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It should be noted that the above compound (9) of Vaisburg is an isomer of the third compound recited in instant claim 29:
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Compound (9) of Vaisburg has Cl substituents in a different position than the compound recited in instant claim 29.
Compound (9) of Vaisburg is used in synthesis of larger compounds which all bear Cl groups attached to benzene ring at positions 3 and 4.
The teachings of Vaisburg are directed to:
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Without a teaching or suggestion from prior art a person of ordinary skill in the art would not have been motivated to change the position of Cl groups to arrive at the instant compounds with a reasonable expectation of success.
Conclusion
Claims 12-15 are rejected.
Claims 32, 43, 52, 62, 63 and 67-69 are withdrawn.
Claims 16, 19, 20, 29, 65 and 66 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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, Clinton A 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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/I.S./Examiner, Art Unit 1621
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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