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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/11/26 has been entered.
Claims 3-4, 6-7, 9-14, 16-19, 22-30, 32, 36-38, 40-41, 43 and 47 have been canceled.
In the claims set of 10/2/2025 claims 40-43 were cancelled. Please confirm the status of claim 42 as being canceled
Claims 1, 15 and 42 have been amended. Claims 44-46 and 48 are withdrawn.
Claims 1-2, 5, 8, 15, 20, 21, 31, 33, 34, 35, 39, 42 and 49-50 are under examination.
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.
Claim(s) 1, 2, 5, 8, 15, 20, 21, 31, 33, 34, 35, 39, 42 and 49-50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hsia et al. WO 9857550 12-23-1998.
Claim 1,2,5,8, 15, 49-50: Hsia et al discloses an antimicrobial yogurt composition (chewable product) which comprises copper gluconate, zinc gluconate, viable/living and probiotic Lactobacillus plantarum. Hsia et al disclose the Lactobacillus species can be acidophilus, plantarum or yeast. See p. 1 lines 10-19, p. 6 lines 34-36, p. 8 lines 4-26, p. 9 lines 9-19, p. 12 lines 1-13 and example 3 and 4.
In example 3, for instance, using the % calculated amount of copper gluconate (5072g, 0.054%) and zinc gluconate (39,773g, 0.42 %) in the total weight of composition (93540g) and the corresponding amounts in 60g (zinc gluconate 25g, copper gluconate 3.25g) dissolved in about 8 ounces (236.58 mL) of water, the w/v (per 100 mL) is approx. 1.37% w/v for copper gluconate and approx. 10.59% w/v for zinc gluconate, meeting the limitations of at least 0.05% w/v or greater than 0.1 % w/v for zinc gluconate and meeting the limitations of at least 0.01% w/v or greater than 0.2 % w/v for copper gluconate.
Claim 20, 21, 31, 33, 34, 35, 39 and 49 recite the intended uses of the claimed composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Response to Applicant’s Argument:
Applicant argues that Hsia does not disclose the viable Lactobacillus plantarum feature. Applicant’s argument has been carefully considered but is not found persuasive.
This is because Hsia et al on page 4 disclose that Lactobacillus that may be employed include Lactobacillus plantarum.
Thus, Hsia et al disclose at least the 3 elements of claim 1: Hsia et al discloses an antimicrobial yogurt composition (chewable product) which comprises copper gluconate, zinc gluconate, viable/living Lactobacillus plantarum as set forth in the above rejection.
Applicants argue that they have surprisingly found a synergistic effect of using live Lactobacillus plantarum in combination with copper gluconate and zinc gluconate and the surprising synergistic effect is demonstrated across a variety of microbes and that the surprising effect produced by the inclusion of viable Lactobacillus plantarum in the composition could not have be predicted or even contemplated from the disclosure of Hsia ant that this is because Hsia specifically describes dietary supplementation with Lactobacillus acidophilus and that the only mention of Lactobacillus plantarum comes in a large list of prophetic examples with no special emphasis placed on Lactobacillus plantarum, let alone viable Lactobacillus plantarum and as such, there would be no motivation for one skilled in the art to even try using viable Lactobacillus plantarum to improve antimicrobial effects of a composition, let alone any expectation of success for doing so and that this is especially true given that Hsia is concerned with preparing yoghurt.
Applicant’s argument has been carefully considered but is not found persuasive.
Evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). See MPEP 2131.04. In addition, a prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)). See MPEP 2121. Regarding, the list of Lactobacillus, Hsia et al discloses any of the Lactobacillus listed as being able to be employed in the composition.
As stated in the prior action, the word “antimicrobial” does not convey any structural limitations on the claimed composition. The composition of Hsia et al meets the limitations of the claim. The claims are not drawn to a method of treating A. baumannii , P aeruginosa, E. cloacae and S. Aureus or any other microbial infection in a subject.
For these reasons the rejection is maintained.
Status of Claims
Claims 44-46 and 48 are withdrawn. Claims 1, 2, 5, 8, 15, 20, 21, 31, 33, 34, 35, 39, 42 and 49-50 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645