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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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419
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Information Disclosure Statement
Filed information disclosure statements (IDS) comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Response to Election of Species
Applicant's response to election of the following species in the reply filed on 04/21/2026 is acknowledged:
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566
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Above species read claims 1-4, 6-13 and 19-20.
Claims 5 and 14-18 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The claims 1-4, 6-13 and 19-20 are examined on merits, to the extent elected species read, in this office action.
Sequence Non-compliance
The claim 20 and Table 6 and Scheme 1 in Specification are objected because of the following informalities: both fail to comply with 37 CFR 1.821 (a)-(d) which requires reference made to transmembrane sequence(s) by use of the sequence identifier, preceded by "SEQ ID NO:" in the text, even if the sequence is also embedded in the text of claim and the patent application. See MPEP §2422. Appropriate correction is 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 1-4, 6-10, 12-13 and 19-20 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 pre-AIA the applicant regards as the invention.
Claims are rejected as being incomplete for omitting essential step(s), such omission amounting to a gap between the steps. See MPEP § 2172.01 [R-07.2022].
In this case, claimed subject matter require that food item must have a disulfide bond containing protein, in order form a disulfide bond in the linear bacteriocin. If there is no disulfide bond formation, there won’t be any activity in linear bacteriocin. Accordingly claim 1 and its dependents are missing essential subject matter.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-4, 6-10, 12-13 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Johnsen (APPLIED AND ENVIRONMENTAL MICROBIOLOGY, Nov 2000, vol. 66, No.11, 4798-480) in view of Kolsek (Scientific Reports, 2017|7: 9858|DOI:10.1038/s41598-017-07501-4) and Bagenda (Food, 2007, 1(2), 137-148).
For claim 1:
Johnsen teaches that Pediocin PA-1 is a food grade antimicrobial peptide that has been used as a food preservative, wherein PA-1 is a class II bacterium. Replacing Met31 by Ala, Ile, or Leu protected the peptide from oxidation and had only minor effects on bacteriocin activity. Johnsen further teaches activities of mutant pediocin PA-1, including applicants elected ped[M31L], on gram positive bacterium. [See Abstract, 1st paragraph in left column in page 4798, Fig.1 and Table 2].
The above is interpreted as a method of inhibiting or preventing gram positive bacterial growth by administering ped[M31L].
Differences between Johnsen and instant claim(s) are as follows:
(i) Johnsen silent on administering linear peptide of Pediocin PA-1, wherein in situ disulfide bond formation occurs in the linear peptide when contacts the food matrix.
(ii) Johnsen silent on method of preserving a food item by administering Pediocin PA-1 or its variant.
With regard to (i) of above, in situ disulfide bond formation occurs, through thiol-disulfide bond exchange reaction, in the linear peptide if disulfide bonds are present in the food matrix as evidenced from the teachings of Kolsek [see abstract and pages 1-2]. Therefore, a skilled person in the art would be motivated to avoid additional step of cyclizing the Cys moieties in the Pediocin PA-1, since a skilled person knows that disulfide bond formation occurs in the linear Pediocin PA-1 on the surface of food matrix.
With regard to (ii) of above, bacteriocins are known as food preservatives in the art. For example, Bagenda teaches application of bacteriocins in food preservation and safety [see abstract and Tables 1-2] and further teaches these can also be applied to fish products, such as salmon [see section Fish Products, in pages 140-141].
Based on the above, a skilled person in the art would be motivated to make a method of preserving food item by administering bacteriocin or its variant, such as applicants elected species with a reasonable expectation of success, because above art provided advantages and utilities of bacteriocins.
For claims 2-4:
Since the applicants native reference sequence is identical to the Pediocin PA-1 of Johnsen peptide, and further art teaches mutation at M31L, and so, the Pediocin PA-1 must be gram positive class IIa bacteriocin.
For claims 6-7:
In the teachings of Johnsen, ped[M31L] variant has more than 80% identity with native reference sequence and it is an amino acid substitution .
For claim 8:
Typically “preserving a food” means protecting or preventing it from contamination or infection etc. The food can be mixed with preservative or spill preservative over the food etc. Spray is an easy and efficient technique to get the job done and is a commons sense technique in the art, and so, it is an obvious limitation. In addition, as explained above under For claim 1, Bagenda teaches bacteriocins as a food preservatives and further teaches it can be sprayed [see section Meat products in page 140], which can be easily extrapolated to apply on fish products.
For claim 9:
Johnsen silent on applicants claimed concentration range. Hover, generally, differences in concentrations of components of a formulation will not support the patentability of subject matter encompassed by the prior art. Such formulations are results-effective variables which can be optimized. In in re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980), it was held that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Further, in In re Aller, 220 F. 2d454, 456, 105 USPQ 233,235 (CCPA 1955) the courts maintained that: "Where the general condition of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." As formulating optimal compositions for medicaments is routine in the art of pharmacology, the claims are considered to be prima facie obvious.
For claim 10 and 12-13:
See For claim 1 above.
For claim 19:
Though Johnsen teaches gram-positive bacterium [see Table 2], but silent on listed species in the claim. However, shown data in the Johnsen can be extrapolated to other bacterium and is expected to be effective. Regardless, Bagenda teaches that bacteriocins have been successfully used to control the growth of L.monocytogenes in cold smoked salmon [see left column, 2nd paragraph in page 141].
For claim 20:
See For claim 1 above.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual limitations in the claimed method, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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