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 1-15 are pending and currently under examination and the subject matter of the present Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/08/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the Examiner.
Claim Objections
Claims 1, 6-7, and 13 are objected to because of the following informalities:
Claim 1 recites “A liquid antimicrobial” which appears to be missing the word “composition” after “antimicrobial”.
Claim 6 refer to potassium cation in a concentration of at least 0.6 mol per mol of acetate; Claim 7 requires bacteriocin in a concentration of 5-30 mg per mol of acetate. Concentrations are not typically written in mass per mol of another component. In chemistry, concentration is the abundance of a solute divided by the total volume or mass of a mixture, which is not the case for these 2 claims. Applicant is either reciting a ratio or an amount in comparison to another amount in a different unit, which is confusing.
Claim 13 uses the term “then” multiple times to indicate succeeding steps. This term is not typically used in claims as it makes the claims appear narrative.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
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.
Claims 1-15 are 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 1 is indefinite because it lists components a), b), c), and f). As such, there is a question as to whether “f)” is a typographical error or if elements d) and e) are missing. Furthermore, the last line in Claim 1 recites “wherein the antimicrobial composition”, which is an incomplete phrase, suggesting that there are limitations that may have been omitted. As such, the metes and bounds of the claim is unclear making it indefinite and rejected.
Because Claim 9 requires the application of the composition in Claim 1, the claim is also rejected. All claims depending from Claims 1 and 9 are also rejected for indefiniteness.
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 6 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 which it depends.
Claim 6 depends from Claim 1, and requires the potassium cation to be at least 0.6 mol per mol of acetate, however, Claim 1 requires that the cation is at least 0.7 mol per mol of acetate. As such, Claim 6 fails to further limit but rather broadens the scope of 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.
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 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 1-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wilhoit, D. (US 5,573,797).
Wilhoit discloses an antimicrobial composition comprising a Streptococcus-derived or Pediococcus-derived bacteriocin or synthetic equivalent antibacterial agent in combination with a chelating agent, and methods of protecting foodstuff (Abstract).
Regarding Claim 1, Wilhoit teaches examples of various test solutions and concentrations of antimicrobial nisin and pediocin (Table 1a). Table 1 shows the pH of the solutions range from 4.0 to 7.3, which overlaps with the claimed range (Examples 5-28). Regarding component a), the nisin/pediocin bacteriocin concentration ranges from 1 ppm to 125 ppm, which overlaps with the claimed range in Claims 1-2 (Examples 5-28).
Regarding component b), Wilhoit teaches 0.8% Na2EDTA and 3% Na3EDTA, reading on the acetate feature (Tables 1a, 1b, and 2). By Examiner’s calculation 3% Na3EDTA is equivalent to 0.1 mol/L. However, Wilhoit also teaches that more than 3% of the chelating agent may be used (Col. 8, lines 40-42). Finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. See Pfizer Inc. v. Apotex Inc., 82 USPQ2d 1321 (Fed. Cir. 2007) (discovery of an optimum value of a variable in a known process is usually obvious.). The idea that optimizing an ordinary variable does not by itself constitute a patentable advance was also stated in In re Geisler, 43 USPQ2d 1362: “…“it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. Note MPEP §2144.05(II). Likewise, optimization of a range or other variable within the claims flows from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 65 USPQ2d 1379, 1382.
Regarding component c), Wilhoit Na3EDTA, which has 3 mols of sodium cation to 4 acetate in EDTA, i.e. about 0.75 mol cation per mol acetate (Table 2). The chelating agents and bacteriocin are prepared with deionized water, and the tests solutions in Table 2 were all water based, which renders the f) component obvious (Col. 17, lines 27-31; Col. 21, lines 29-31).
Because Wilhoit teaches pediocin, Claims 3-4 are obvious.
Regarding Claims 5-6, Wilhoit teaches 0.8% Na2EDTA and 3% Na3EDTA, reading on the acetate feature (Tables 1a, 1b, and 2). Regarding the potassium cation claimed, Wilhoit teaches the chelating agents inter alia EDTA are commonly used as salts of alkali metal or alkaline earth salts such as sodium, potassium or calcium or quaternary ammonium salts (Col. 5, line 63; Col. 7, lines 4-7).
Regarding Claim 7, Wilhoit teaches 3% Na3EDTA, which is equivalent to 0.1 mol/L EDTA (Tables 1a, 1b, and 2); and bacteriocin concentration ranges from 1 ppm to 125 ppm, which is equivalent to 1-125 mg/L (Examples 5-28). Therefore, at 1 mg bacteriocin and 0.1 mol EDTA, the bacteriocin is 10 mg per mol acetate.
Regarding Claim 8, the compositions of Wilhoit comprises the bacteriocin at 0.0001%-0.0125%, and the chelating agent inter alia sodium EDTA at 0.8% or 3%, and the rest is water if there are no optional additives included, as such, the chelating agent constitute at least 98% of the dry matter (Tables 1a, 1b, and 2).
Regarding Claims 9 and 11, Wilhoit expressly teaches coating frankfurters by immersion in the test solutions (Col. 24, lines 25-27; Col. 25, 30-36).
Regarding Claim 10 and 14, Wilhoit teaches its composition may be employed with fish (Col. 23, lines 32-50). As such, one skilled in the art would be motivated to simply substitute the meat/frankfurter with fish based on Wilhoit’s teaching that the compositions are also useful for fish.
Regarding Claim 12 and 15, Wilhoit expressly teaches submerging frankfurters in the test liquid for 30 seconds, and holding the frankfurter vertically to drain for another 30 seconds, which reads on the 1 minute, and also teaches washing with sterile buffer, which reads on the aqueous liquid (Col. 20, lines 40-56; Examples 29-43).
Regarding Claim 13, Wilhoit teaches that use of the combination of nisin and Na3EDTA produced a surprising and unexpected reduction in both average plate counts for Listeria and total aerobic bacteria for the two day test period (Col. 23, lines 11-23; Table 2).
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wilhoit, D. (US 5,573,800), Wilhoit, D. (US 5,573,801).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached on M-F, 10-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached on (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANICE Y SILVERMAN/Examiner, Art Unit 1792
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