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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 06/07/2024 has been considered by the Examiner inasmuch as foreign documents have been submitted into the file wrapper in English.
Claim Status
The preliminary amendment filed June 07, 2024 has been entered. Claims 1-6 are canceled. Claims 11-19 are new.
Thus, claims 7-19 as amended are examined on the merits herein.
Claim Interpretation
(I) Claim 7, line 1, recites “an anti-infective composition”; where the Examiner notes claims 8-14 depend from or rely on the composition of claim 7.
Additionally, claims 10 and 12-14 each recite in line 1, “An anti-infective drug”.
Moreover, claim 15, line 1, recites “An anti-infective method”; where the Examiner notes claims 16-19 depend from or rely on the method of claim 15.
Accordingly, in view of the claim recitations above, the Examiner notes the specification does not define “anti-infective” nor does the disclosure limit the scope of the term “anti-infective”.
Therefore, the Examiner reasonably interprets the “anti-infective composition”; “anti-infective drug”; and “anti-infective method” are open-ended and may include any infectious or infective agent including but not limited to bacteria, viruses, fungi or parasites.
Thus, the Examiner notes if the prior art discloses a composition and/or method comprising sodium formate and an aminoglycoside antibiotic; said prior art will read on the “anti-infective composition”; “anti-infective drug”; and “anti-infective method” where applicable.
(II) Claim 15, lines 2-4, recite “to enhance sensitivity of a bacterium to the antibiotic by a synergistic effect of the sodium formate and the antibiotic, thereby killing the bacterium and achieving an anti-infective effect”.
Claims 18-19 narrow the scope of said bacterium.
The Examiner reasonably interprets the limitations within claims 15 and 18-19 are physical and/or functional limitations of combining sodium formate with an antibiotic as required in claim 15, line 2.
Therefore, if the prior art discloses an anti-infective method comprising combining sodium formate with an antibiotic; said prior art will read on the limitations of claims 15 and 18-19 as discussed above.
Claim Rejections - 35 USC § 103
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 7-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ayon-Covarrubias (hereafter referred to as "Covarrubias", Published 27 June 2000, US-6080744-A, PTO-892) in view of Mladenovich (Published 18 November 2010, WO-2010130028-A1, PTO-892).
Regarding claims 7-19, Covarrubias teaches a topical mycological treatment composition for medical use (e.g. an anti-infective composition, required in claim 7, line 1; anti-infective drug, required in line 1 in each of claims 10 and 12-14; and anti-infective method, required in claim 15 as interpreted by the Examiner above); containing as active ingredients clotrimazole, ketoconazole, micanazole, nystatin, tolnaftate, propionic acid, sodium propionate, undecelynic acid, and zinc undecelynate wherein said ingredients are contained within a natural cream base; and may also contain an antibacterial agent, see abstract.
Covarrubias exemplifies said antibacterial agent as gentamicin (e.g. gentamicin, required in claim 8, line 3, claim 12 and claims 16-17) in an amount of 0.01 to 0.5 grams per 100 grams of said base, see Col. 4, claim #2.
Covarrubias teaches a method of treating a topical fungal infection in a patient using said composition, see Col. 4, claim #8; which also includes an effective amount of an antibacterial agent, see Col. 4, claim #9.
Although, Covarrubias does not teach the sodium formate required in claims 7-19.
However, in the same field of endeavor of topically treating fungal infections, Mladenovich teaches pharmaceutical compositions suitable for the topical treatment of fungal infections where the active ingredients of the compositions are low molecular weight organic acids and their salts in synergistic combination of two or more acids, see abstract.
Maldenovich exemplifies said organic acids within the composition are used in their salt form wherein the salt forms are metal salts, see pg. 17, claim #5, including alkali metal salts, see pg. 17, claim #6; in which the low molecular weight organic acids are formate salts, propionate salts and benzoate salts, see pg. 17, claim #7; wherein said formate salt is exemplified as sodium formate, see pg. 17, claim #8, line 2.
Maldenovich exemplifies the % by weight within a gel formulation, wherein said gel formulation contains 3% by Wt. of sodium formate, see pg. 11, Example 2, lines 5-10.
The Examiner notes the exemplification of 3% by Wt. of sodium formate within the composition of Maldenovich reasonably corresponds to 3 grams per 100 grams of base.
Additionally, the Examiner reiterates the teaching of Covarrubias above, where Covarrubias exemplified gentamicin in an amount of 0.01 to 0.5 grams per 100 grams of base as discussed above.
Accordingly, the Examiner further notes when 0.5 grams of gentamicin per 100 grams of base is chosen, the base taught by the combination of Covarrubias and Mladenovich teach a mass ratio of sodium formate to gentamicin which is 6:1 and is encompassed within the mass ratio claimed within instant claims 9 and 11.
It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have incorporated the sodium formate as taught by Maldenovich into the compositions and methods taught by Covarrubias as within the scope of the artisan as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to treat the fungal infection in the patient of Covarrubias; particularly because Maldenovich teaches pharmaceutical compositions comprising organic acids which include sodium formate in synergistic combination with two or more acids for the topical treatment of fungal infections. One of ordinary skill in the art would have had a reasonable expectation of success to have made the addition of sodium formate as taught by Maldenovich above into the compositions and method as taught by Covarrubias; as both Covarrubias and Maldenovich are drawn to compositions comprising low molecular weight organic acid salts for topically treating fungal infections as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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