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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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 Restriction
Applicant's response to restriction requirement and election of group I corresponding to claims 16-23, without traverse, in the reply filed on 06/10/2026 is acknowledged.
The examiner also acknowledges applicants response to election of species and providing following species for the claimed composition:
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Claims 24-28 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 16-23 are examined, in light of elected species, on merits in this office action.
Claim objections
Claim 17 is objected to because of the following informalities: dots in the “SEQ.ID.NO:” should be removed. These should be represented by “SEQ ID NO:”. Appropriate correction is required.
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 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Broekaert (US5750504) or Thevissen (The Journal of Biological Chemistry, 19 Dec 1997, vol.272, No.51, 32176-32181) in view of Pohl (Science against microbial pathogens: communicating current research and technological advances, ©FORMATEX 2011, A. Méndez-Vilas (Ed.)) and Zemek (Folia Microbiol., 1987, 32, 421-425).
For claims 16-17:
Broekaert teaches composition comprising a protein represented by SEQ ID NO:1, which is identical to applicants elected Hs-AFP1 corresponding to SEQ ID NO:1 [see claims 1 and 3], wherein the protein is for combating fungi or bacteria [see claim 3]. Broekaert further teaches that the antimicrobial protein [SEQ ID NO:1] is obtained from the seeds of Heuchera sanguinea [see col.1, lines 61-65].
OR
Thevissen teaches Hs-AFP1, a plant defensin from seed of the plant Heuchera sanguinea [see abstract], wherein the Hs-AFP1 shows antifungal activity [see Table 1], wherein Hs-AFP1 in the fungal activity measurements, as shown in Table 1, is interpreted as a composition comprising Hs-AFP1.
Difference is that both Broekaert and Thevissen silent on fatty acid, viz., applicants elected crotonic acid.
However, fatty acids are “art recognized antimicrobial and antibacterial agents”. For example, Pohl teaches antifungal activity of saturated fatty acids, for example Pelargonic acid [see Table 1], and also unsaturated fatty acids, for example, butanoic acid (aka crotonic aicd) [see Table 2]. Zemek also teaches that crotonic acid as an antimicrobial agent [see Table I].
Established case law states that generally, if it is known to use A, and known to use B for the same purpose, then it is obvious to use both A and B, In re Susi, 169 USPQ 423, 426; In re Kerkhoven, 205 USPQ 1069. Thus, combining them flows logically from their having been individually taught in the prior art.
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). In this case, both defensin and fatty acid have same property, and so a skilled person in the art would be motivated to combine these components to see any additional or synergistic effect on microbes.
For claims 18-21:
Concentrations of components in a given composition is considered as result effective variables and the differences in their amounts will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such differences in result-effective variables are critical. 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. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
For claims 22-23:
The claimed FIC index is expected in combination, since individual components are identical in claimed subject matter and in the cited art, absent evidence to the contrary.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components in the composition and their property as antimicrobial, 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 composition with a reasonable expectation of success.
A combination of prior art references is only proper if a person of ordinary skill in the art (POSA) at the time of the invention, faced with the same problem, would have been motivated to combine their teachings with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here, the technical fields and problems addressed by the references are not distinct from that of the present invention.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658