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 .
Status of Claims
The following have been acknowledged
Claims 1-3 and 6-9 are rejected
Claims 4 and 5 are objected to
Information Disclosure Statement
All references from IDS(s) received 10/02/2024 and 01/12/2026 have been considered unless marked with a strikethrough.
Claim Interpretations
The term “microbial” (claim 1) was interpreted as including all microorganisms, including fungi, bacteria and viruses.
Claim Rejections - 35 USC § 112
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 1-9 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.
Level of skill and knowledge in the art:
ALPTÜZÜN (2009, Molecules, 14, 5203-5215) teaches certain substitutions on a pyridinium salt have differing effects on certain bacteria (page 5206, Table 1), and BUŠIĆ (2022, Croat. Chem. Acta, 95(1), 31-38) teaches similar concepts (page 36-37, Tables 6 and 7).
(2) Structure/Function Correlation:
In the case of the prior art listed above, there is a lack of structure to function correlation such that minor changes in structure lead to large changes in function. In the case of Alptüzün, the differences between structures 2a, 2c and 2d against certain
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bacteria such a P. aeruginosa and C. albicans had no correlation between the structure and function, with the minimum inhibitory concentration (MIC) differing greatly between each structure showing a lack of correlation. In the case of Bušić, compounds 2 and 9,
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while structurally similar and only differing by the length of the carbon chain, showed no correlation between their structure and activity for different fungi, such as F. culmorum and B. cinerea (Table 6 and Table 7).
(3) Lack of Representative Number of Examples
The instant case teaches a limited number of compounds within the specification that are not a representative number of examples for all the structural space that is represented by the claim.
(4) Conclusion
In view of the prior art showing that there is unpredictability with respect to structure and function, and the lack of representative number of examples, it is reasonable in the instant case to conclude that the applicant was not in possession of the knowledge of which compounds within the genus laid out in the claims would be active against microbes, and/or which compounds within the genus would act on which microbes.
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 1-3 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over QI (2024 April 17, Pest Manag. Sci., 80, 4098-4109) in view of BERGE (1977, January, Journal of Pharmaceutical Sciences, 66, 1-10).
Regarding Claims 1-3 and 6-9, Qi discloses a β-hydroxy pyridinium salt and the use of these compounds, such as compound 4K and 4L (Figure 1), shown below, which contain a pyridinium bromide, with a 2-hydroxyalkyl, with an oxygen at position Y and a substituted aryl at position R1, and R5 is an O-alkyl. Said compounds are substituted pyridinium chloride/bromide compounds with an average molecular mass between 100 to 1500 m/z, where the compounds are dissolved in a solution of water to form multiple dosing formulations to inhibit microbial growth.
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Qi fails to disclose the use of a chloride salt of compounds 4K and 4L.
However, Berge discloses FDA-approved commercially marketed salts for pharmaceuticals, which includes bromide and chloride salts.
Qi and Berge are considered to be analogous to the claimed invention as Qi is focused on the synthesis of a novel β-hydroxy pyridinium salt that is to be used as an antibiotic, and Berge focuses on the formation of pharmaceutical salts. Therefore, it would have been obvious to a person having ordinary skill in the art (PHOSITA) prior to the filing of the instant application to have modified the teachings of Qi to incorporate the exchange the bromide anion on compounds 4K and 4L based on the teachings of Berge.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EVAN G. THOMAE whose telephone number is (571)270-7609. The examiner can normally be reached 8:00 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.G.T./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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