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 . 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.
Election/Restrictions
Applicants elected group I and SEQ ID 15 with traverse in the reply filed on 13 March, 2025. The traversal was found unpersuasive, and the election/restriction requirement made final in the office action of 10 April, 2025.
Claims Status
Claims 7, 8, and 10-19 are pending.
Claims 7, 8, and 10-15 have been amended.
Claims 16-19 are new.
Claims 8, 10-12, 14-16, and 19 have been withdrawn due to an election/restriction requirement.
Withdrawn Objections
The objection to the specification due to a non-specific title is hereby withdrawn due to amendment.
The objection to the specification due to embedded hyperlinks is hereby withdrawn due to amendment.
Withdrawn Rejections
The rejection of claims 1, 7, and 13 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is hereby withdrawn due to amendment.
The rejection of claims 1, 7, and 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to inconsistencies in the use of the term “PAMP polypeptide” is hereby withdrawn due to amendment.
The rejection of claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to “preferably” language is hereby withdrawn due to amendment.
The rejection of claim 7 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is hereby withdrawn due to amendment.
The rejection of claim(s) 1 and 13 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Thompson et al (US 20190023750) is hereby withdrawn due to amendment.
The rejection of claim(s) 1, 7, and 13 under 35 U.S.C. 103 as being unpatentable over Thompson et al (US 20190023750) in view of Wandall et al (US 20130059744), Matsumoto et al (US 20120283102), Martin et al (US 20170107531), Bohm et al (PLOS Pathog. (2014) 10(11) e104491), Kunze et al (Plant Cell (2004) 16 p3496-3507), Huffaker et al (PNAS (2006) 103(26) p10098-10103), and Hou et al (PLoS Pathogens (2014) 10(9) e1004331) is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 103
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) 7, 13, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson et al (US 20190023750) in view of Wandall et al (US 20130059744), Matsumoto et al (US 20120283102), Martin et al (US 20170107531), Bohm et al (PLOS Pathog. (2014) 10(11) e104491), Kunze et al (Plant Cell (2004) 16 p3496-3507), Huffaker et al (PNAS (2006) 103(26) p10098-10103), Hou et al (PLoS Pathogens (2014) 10(9) e1004331), and Dalrymple et al (PNAS (2001) 98(20) p11627-11632).
Thompson et al describe peptides that protect a plant or plant part from disease and/or increase the innate immune response of the plant or plant part (paragraph 28). In other words, PAMPs, although the reference does not use that acronym. Among the sequences listed as useful for this purpose are SEQ ID 530 (identical with SEQ ID 2 of the examined application) and SEQ ID 731 (identical with SEQ ID 9 of the examined application) along with other flagellin or flagellin associated polypeptides (paragraph 30). Fusion proteins, comprising multiple actives, such as multiple flagellin associated polypeptides, are discussed (paragraph 314). Examples of sequences with more than 3 proteins are mentioned (paragraph 355). Formulations including carriers are mentioned (paragraph 308), with water (aqueous), vermiculate, clay, dolomite, gypsum, bentonite, titanium dioxide, activated charcoal, and talc mentioned (paragraph 309). The material can be formulated as an aqueous solution, a dispersion, an emulsion, or a powder or granule (paragraph 310).
The difference between this reference and the examined claims is that this reference does not discuss several segments in SEQ ID 15.
Wandall et al discuss bait peptides that bind to glycans (abstract). Among the sequences discussed is SEQ ID 32 (paragraph 261); the first 42 amino acids of which are identical to the first 42 amino acids of SEQ ID 15 of the examined claims (p58). Matsumoto et al suggest that this is a His tag, a T7 tag, and a thrombin cleavage sequence (paragraph 54 and comparison of SEQ ID 2 and SEQ ID 4), presumably so as to make it easy to fish the polypeptide (and associated glycans) from the sample matrix and then remove the tags. These references discuss various tags and a cleavage sequence.
Martin et al discuss compositions for increasing disease resistance in plants (abstract), i.e. PAMPs. One of the sequences used, SEQ ID 2, is identical with SEQ ID 8 of the examined claims (paragraph 85). Note that this sequence is known from the prior art to help with disease resistance (paragraph 8). This reference discusses a PAMP.
Bohm et al discuss a microbial peptide pattern that triggers immunity in a plant (title), a PAMP (2nd page, 2nd column, 3d paragraph). Overlapping fragment sequences of the full length protein were tested for activity (3d page, 2nd column, 1st paragraph), and mutagenesis studies were conducted to determine the critical residues (4th page, 1st column, 1st paragraph). Note that the minimum sequence of the full length protein that triggers the effect is identical with SEQ ID 3 of the examined claims (table 1, 5th page). This reference discusses an additional PAMP species.
Kunze et al looks at the bacterial elongation factor Tu as an innate immune system stimulator in plants (title); a protein known to be a PAMP (abstract). The N-terminal 18 amino acids were important for activity; deleting position 18 led to a large reduction of activity (p3500, 1st column, 2nd paragraph). An alanine mutation experiment was conducted to determine which residues are important (p3500, 1st column, 3d paragraph, continues to 2nd column). Note that the N-terminal 18 amino acids are identical to SEQ ID 4 of the examined claims (fig 5, p3501, top of page). This reference discusses yet another PAMP peptide sequence.
Huffaker et al discuss an endogenous peptide signal that activates the innate immune system of a plant (title). Note that this sequence is identical with SEQ ID 6 of the examined claims (fig 1, p10098, 2nd column, top of page). A transgenic plant that overproduced this peptide had enhanced resistance to a root pathogen (abstract). While not a PAMP (it’s not a pathogen associated sequence), this reference discusses a peptide that enhances the innate immune system of a plant, making it obvious to use it in that context.
Hou et al discuss the peptide PIP1, which amplifies immunity (title) of a plant (abstract). While this is a 23 amino acid sequence, the C-terminal conserved sequence is presumed to be responsible for activity (3d page, 2nd column, 1st paragraph), which is the sequence RLASGPSPRGRGH (fig 1a, 3d page, top of page). A transgenic plant that overproduced a precursor sequence proved to have greater resistance to a pathogen than the wild type sequence (4th page, 2nd column, 2nd paragraph). This reference discusses another sequence that induces immunity in plants.
Dalrymple et al discuss fusion proteins of different binding sequences (p11627, 2nd column, 4th paragraph). These segments were separated by Gly-Ala-Gly or Ala-Gly-Ala linkers (p11627, 2nd column, 4th paragraph). This reference discusses linkers between segments of a fusion protein.
Therefore, it would be obvious to add the sequences of Martin et al, Bohm et al, Kunze et al, Huffaker et al, and Hou et al to the fusion protein of Thompson et al, as these references describe sequences with similar activity (activating the innate immune system of plants). As Thompson et al discuss fusion proteins of multiple sequences with this activity, an artisan in this field would attempt this combination with a reasonable expectation of success. Note that this is a combination of known elements yielding expected results.
Furthermore, it would be obvious to add the sequence of Wandall et al, to provide a cleavable handle to the sequence, as implied by Masumoto et al. As this sequence, and derivatives of it, is common in the art, an artisan in this field would attempt this addition with a reasonable expectation of success.
Finally, it would be obvious to add the linkers of Dalrymple et al between at least some of the segments of the fusion protein of Thompson et al, as a combination of known elements yielding expected results. As simple linkers such as those of Dalrymple et al are common in the art, an artisan in this field would attempt this addition with a reasonable expectation of success.
Wandall et al discusses a sequence with an N-terminal Met residue, suggesting an N-terminal position. While there is no suggestion of the ordering of the remaining sequences, there is nothing of record suggesting that the specific order is important. Dalrymple et al teaches the linkers applicants have used between these segments. Thus, the combination of references renders obvious SEQ ID 15, and claim 7.
Claim 13 requires that the material be a plant immune inducer, but Wandall et al teaches that the sequences of that reference have that function, rendering this claim obvious.
Thompson et al mentions carriers, rendering obvious claim 17.
Thompson et al mentions aqueous and powder/granule ingredients, rendering obvious claim 18.
response to applicant’s arguments
Applicants argue that the fusion protein is a better immune stimulator than the individual segments that make it up.
Applicant's arguments filed 10 July, 2025 have been fully considered but they are not persuasive.
Applicants argue that the fusion protein is better than the individual segments, which they argue is an unexpected result. There are a number of issues with this argument. First, unexpected results are compared to the closest prior art (MPEP 716.02(e)), which is Thompson et al. Thompson et al discusses fusion proteins, not the individual segments. Second, it is applicant’s responsibility to show that the results are statistically significant (MPEP 716.02(b)(1)). Applicants have not met that burden. Finally, applicants must show (MPEP 716.02(a)) and explain (MPEP 716.02(b)(II)) the unexpected results. At best, applicants have demonstrated that the fusion protein has better activity than any one of the PAMPs used to make it up. It is not clear why this would be surprising; assuming the concentrations are high enough to saturate whatever each segment binds to, the results would be assumed to be additive – a person of skill in the art would reasonably predict that the fusion protein would perform better.
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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658