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 .
Response to Amendment
The amendment received on 01/22/2026 is acknowledged. Claim 12 has been amended. Claims 1-6 and 8-20 are currently pending. Claims 2, 8-11, 13 and 17-20 stand withdrawn. Claims 1, 3-6, 12, and 14-16 have been treated on the merits.
Response to Arguments
In light of the declaration submitted applicant has perfected the deposit of biological material. The rejection of claims 1, 3-6, 12 and 14-16 under 35 U.S.C. 112(a) is withdrawn.
Applicant’s arguments regarding the rejection of claims 12 and 14-16 under 35 U.S.C. 101 have been fully considered but are not persuasive. The description “isolated” does not impart a structural limitation which makes the viruses markedly different than the product of nature. Further as claimed, while a description of “isolated” implies that a step of isolation has occurred and the product of the process is being claimed, a product by process only limits the product to the structure implied. In the instant case the virus would still be the same. As applicant is claiming a method however, applicant may decide to amend the claims to include a step of culturing and isolating the viruses from culture, which might differentiate the process from a natural process. However, such limitations would have to be examined to know for sure and further examiner for compliance to other statutes.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 12 and 14-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to a product of nature:
Claim 12 recites a method comprising adding isolated JEP1, JEP4, JEP6, JEP7, or JEP8, or a combination thereof to a composition.
Claim 14 limits the method of claim 12, wherein the composition comprises a food source.
Claim 15 limits the method of claim 14, wherein the food source comprises raw meat, an aquatic product, a raw vegetable, a retail-level ready-to-eat food, a frozen food, and/or a mushroom.
Claim 16 limits the method of claim 12, wherein the method comprises, after adding JEPI, JEP4, JEP6, JEP7, or JEP8, or a combination thereof to the composition, storing the composition at a temperature of up to 4°C, up to 7°C, up to 10°C, or up to 42°C.
These recitations are directed to adding to a composition a nature-based product (bacteriophage). The specification (Pg. 19, lines 5-7) indicates the phages were isolated from food (retail chicken and duck carcasses) and environmental (chicken and pig feces) samples and identified. There is no evidence that the nature-based product in the claim exhibits markedly different characteristics from its naturally occurring counterpart. As evidenced by Lau (Lau, G. et al. Efficacy of a bacteriophage isolated from chickens as a therapeutic agent for colibacillosis in broiler chickens, 2010 Poultry Science, 89:2589-2596/previously cited), bacteriophages are ubiquitous in the environment (Lau Pg. 2590, left column, lines 10-11). A lytic bacteriophage against E. coli was isolated from chicken fecal samples (Lau Pg. 2590, left column, Materials and Methods, lines 6-7). As further evidenced by Debarbieux (Debarbieux, L. et al, Bacteriophages can treat and prevent Pseudomonas aeruginosa lung infections, 2010, The Journal of Infectious Diseases, 201(7): 1096-1104/previously cited) natural bacteriophages isolated from the environment (water) can infect bacteria (Debarbieux Pg. 1097, left column, [1] and [3]).
Claim 12 is recited with a high level of generality, and the act of simply adding can include within it is scope the addition to natural sources, such as the natural spread of these bacteriophages such as how they become introduced to the carcasses or food products described. The description “isolated” does not impart a structural limitation which makes the viruses markedly different than the product of nature. Further while a description of “isolated” implies that a step of isolation has occurred, it is not a claimed step of isolation and only limits the product to the structure implied, i.e. the viruses. In the instant case the virus would still be the same. Claims 14-15 limit the composition to a food source; however as evidenced by the specification (Pg. 19, lines 5-7), phages can occur naturally on food, including raw chicken and duck. Claim 16 recites storing the composition at a temperature and does not impart markedly different characteristics to the product. These temperatures include the majority of temperatures at which live poultry are found. Under the broadest reasonable interpretation, claims 12 and 14-16 are directed to the spread of a naturally occurring bacteriophage on a food source that it naturally grows on at ambient temperature. Therefore, these limitations are product of nature exceptions. As such, claims 12 and 14-16 recite a product of nature (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite additional elements. As such, claims 12 and 14-16 are directed to a product of nature (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite additional elements. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 12 and 14-16 are not patent eligible.
Conclusion
Claims 12 and 14-16 are rejected.
Claims 1, and 3-6 are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES Z CONSTANTINE whose telephone number is (571)270-5533. The examiner can normally be reached Mon-Fri 9-5.
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/CHARLES Z CONSTANTINE/ Examiner, Art Unit 1657
/ROBERT J YAMASAKI/ Primary Examiner, Art Unit 1657
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