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 .
Acknowledgement is made to Applicant’s response filed 09/22/2025.
Claims 1 and 3-25 are pending.
Claims 2 is cancelled.
Claim 1 is marked as previously presented, but concurrently has underlining. Applicant is requested to ensure the claims are provided in appropriate format for examination, including proper underlining, strike-through, and status identifiers.
Claims 7-25 remain withdrawn.
Claims 1 and 3-6 are currently under consideration to the extent that they read upon Applicant’s elected species.
It is noted that Applicant elected as the components present: baicalin and glufosinate.
Rejections Maintained and Made Again in view of Applicant’s Amendments
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 1 and 3-6 (all claims currently under consideration) are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims, as written, do not sufficiently distinguish over compositions comprising baicalin and glufosinate as they exist naturally because the claims do not particularly point out any non-naturally occurring differences between the claimed composition and the naturally occurring compositions. The claimed composition reads upon naturally occurring baicalin and glufosinate.
In the absence of the hand of man, naturally occurring compositions (e.g. red clover) are considered non-statutory subject matter (Diamond v. Chakrabarty, 206 U.S.P.Q. 193 (1980)). It should be noted that the mere purity of a naturally occurring product does not necessarily impart patentability (Ex parte Siddiqui, 156 U.S.P.Q. 426 (1996)). However, when purification results in a new utility, patentability is considered (Merck Co. v. Chase Chemical Co., 273 F. Supp 68 (1967), 155 U.S.P.Q. 139, (District Court, New Jersey, 1967)). The Examiner suggests narrowing the scope of claim 1 to include a non-naturally occurring component. See MPEP 2105.
Response to Arguments
Applicant argues in the Remarks filed 09/22/2025 that glufosinate and baicalin do not exist in combination in nature. Applicant’s argument is not found persuasive. PubChem (Glufosinate) and PubChem (Baicalin) both previously attached evidence that glufosinate has been reported in Streptomyceshygroscopicus and Streptomyces viridochromogenes (see PubChem (Glufosinate), page 2) and baicalin has been reported in Scutellaria prostrata, Scutellaria scandens (PubChem (Biacalin), page 2). As such, both glufosinate and baicalin are known to be naturally occurring. The components do not have to occur together in nature to be properly rejected under 101. Specifically, the components are not required to be found together in nature, but rather, merely acting as they would naturally. Applicant has not established that the combination of glufosinate and baicalin would result in anything other than what would be expected based on their naturally occurring properties. Further, it is noted that L-glufosinate is present in the racemate of glufosinate.
Applicant further argues that the data presented in the Specification support a greater efficacy of baicalin and glufosinate together than on their own. Applicant’s argument is not found persuasive. Specifically, the data does not articulate the efficacy of baicalin on its own but rather, only that baicalin and glufosinate are more efficient than glufosinate alone. As such, the data is not persuasive. Applicant asserts that the Examiner is applying the wrong analysis, and indication of difference from what occurs in nature should be sufficient. It is noted that if this were the case, then 300 mg of naturally occurring component A being combined with 200 mg of naturally occurring component B would result in a composition that is 500 mg, and therefore, weighs more than component A in isolation, therefore, overcoming 101. This is not the standard. A mere difference is not necessarily significantly more. Applicant has given no evidence of significantly more.
For at least these reasons, the rejection is maintained.
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 (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 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.
Claim(s) 1 and 3-6 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Blasiak et al (CN 110637082). This rejection is reformulated to utilize the copy of Blasiak that Applicant has provided in the IDS filed 05/09/2025. Citations are being made thereto.
Blasiak teaches an inoculum composition comprising glufosinate (see entire document, for instance, page 10, last paragraph) and baicalin (see entire document, for instance, page 30, third paragraph, embodiment 21).
Blasiak, while teaching that glufosinate and baicalin are useful in the inoculum composition of Blasiak, does not directly exemplify their use in combination.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention, to utilize both glufosinate and baicalin in the inoculum composition of Blasiak. One would have been motivated to do so since Blasiak teaches both of said components as being useful in the inoculum composition. It is noted that MPEP 2144.07 states “[t]he selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) […] “[r]eading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” 325 U.S. at 335, 65 USPQ at 301.)”. Further, it is noted that MPEP 2144 (I) states that the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed.Cir. 1988) (references do not have to explicitly suggest combining teachings); Ex parte Clapp, 227 USPQ 972 (Bd. Pat. App. & Inter. 1985) (examiner must present convincing line of reasoning supporting rejection); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). Additionally, the art is not required to teach the same reasoning for adding components as Applicant, MPEP 2144 (IV) states “the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by Applicant. See, e.g., In re Kahn, 411 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).”
Response to Arguments
Applicant argues in the Remarks filed 09/22/2025 that the document Applicant provided was not a correct translation and an additional version of Blasiak evidences that the translation is incorrect. Applicant’s argument is not found persuasive against the grounds of rejection above. Specifically, one of ordinary skill in the art, looking at the document provided 05/09/2025 by Applicant would have been motivated to combine baicalin and glufosinate, and one would not have had reason to question the translation since baicalin is a flavonoid. It is noted that even if, arguendo, one were to ignore the teaching of baicalin, the same paragraphs of Blasiak teach quercetin.
Applicant further argues that the prior art does not teach L-glufosinate. It is noted that the racemate of glufosinate comprises both the L and R enantiomer. Applicant has not excluded the R-enantiomer from the claims, and rather, the claims recite “comprising” language which allows the presence of additional components, including the R-enantiomer.
For at least these reasons, Applicant’s arguments are not found persuasive.
Conclusion
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 TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611