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 .
DETAILED ACTION
Applicant’s response dated 08/05/2026 is duly acknowledged.
Claims 1-15 were previously presented on amendment dated 12/06/2023.
Claims 1-6 (non-elected invention of Group I) have been canceled by applicants.
Claims 16-26 (all directly depending from claim 7) have been newly presented.
Claims 7-26 as currently amended/presented are now pending in this application.
Election/Restrictions
Applicant's election with traverse of Group I (claims 7-12 and newly presented claims 16-26; i.e. claims 7-12 and 16-26 with elected species of SEQ ID NO: 42; directed to “An aqueous liquid formulation for improving rainfastness of a protein on a surface of a plant…”) in the reply filed on 08/05/2026 (see REM, p. 1) is acknowledged. The traversal is on the following ground(s) as reproduced below:
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The traversal based on search burden is not found persuasive because- first, the inventions as presented lack unity a posteriori as discussed in the election/restriction sent by the office on 06/29/2026 (see CTRS, p. 5-6) with pertinent teachings from Trotter et al 2010; and second, search burden per se is not pertinent criteria for evaluating lack of unity for inventions in a 371 application. The requirement is still deemed proper and is therefore made FINAL.
Claims 13-15 (non-elected inventions of Groups III-V) have been withdrawn from further considerations.
Claims 7-12 and 16-26 (taken as elected invention of Group II with elected Species of SEQ ID NO: 42, with traverse; directed to “An aqueous liquid formulation for improving rainfastness of a protein on a surface of a plant…”), as currently amended/newly presented have been examined (to the extent they read on the elected species of SEQ ID NO: 42) on their merits in this action hereinafter.
Priority
This application is a 371 of PCT/US2022/073761 (filed on 07/15/2022), which claims domestic benefit from US provisional applications PRO 63/342,064 (filed on 05/14/2022), PRO 63/222,620 filed on 07/16/2021), and PRO 63/222,612 (filed on 07/16/2021).
Claim Objections
Claims 7-12 (as recited) are objected to because of the following informalities: each of the claims 7-12 recite the limitations with phrase “characterized in that…”, which should be amended to recite limitations starting with “wherein…”, instead to improve clarity of the claims. 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.
Claim 10 (as recited) is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recited the term “preferably” or “more preferably” (see lines 6, 7, 10, 17-18, 20, 23-26, for instances), which are taken to mean as "for example", which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention, or just an exemplification of the preceding limitations. See MPEP § 2173.05(d). Appropriate correction is required.
Claim Rejections - 35 USC § 112 – WD Issues
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7-12 and 16-26 (as presented) are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim 7 as currently amended has been reproduced below:
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The BRI of the claimed product in the form of a composition (an aqueous liquid formulation) encompasses any protein, which has been broadly disclosed by applicants as follows (see instant SPEC, p. 8):
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Thus, the formulation as presented may encompass any type of protein, peptide, enzyme, variants, or fragments thereof, that may be useful as well as others that may be toxic and/or environmentally harmful to plants (as long as it’s “rainfastness” is improved on a plant surface). Although, applicants have elected the protein having SEQ ID NO: 42 (which is an enzyme with endopeptidase activity derived from Nocardiopsis sp., as known in the art; see discussion in the prior art rejection below), and have disclosed the formulations comprising said enzyme (a serine protease from Nocardiopsis sp., disclosed as NZ protein # 42; see Examples 1-4, for instance) that is able to improve rainfastness of said enzyme on the plant surface. However, the scope of the claimed formulation as currently presented in claim 7 is not limited to any specific enzyme protein(s), or for that matter any specific pH control agent, or pH range, etc., which would be relevant to improving rainfastness, and/or activity of said enzyme protein, for instance for the benefit of plants in light of the intended disclosure of record (see instant SPEC, section “Background”). No disclosure has been provided regarding various types of pertinent proteins (such as any kind of proteins, regulatory proteins/polypeptides, fusion proteins, or variants thereof, that may encompass phytotoxins, soluble as well as insoluble/aggregated forms, etc., in combination with the broad range and concentrations of any type of “organo-modified siloxane(s)” as recited in instant claim 7, especially with any “pH control component”) such that it would provide reasonable guidance for the combination(s) in the form of an “aqueous liquid formulation” as currently claimed and intended for “improving rainfastness of a protein on a surface of a plant”. It is noted that applicants own disclosure provides evidence/data for significant variations observed, even with one enzyme protein (“NZ protein #42”, a serine protease from Nocardiopsis sp.) studied and disclosed for the aqueous combinations with specific organo-modified polysiloxanes (see SPEC, results in Table 2-4, for instance), and therefore demonstrates the fact that not all proteins, all organo-modified siloxanes, or any pH range and pH control agent, may provide the claimed formulation that would help in the intended functional purposes of “improving rainfastness” on a plant surface. Thus, for the purposes of 112(a) written description, the disclosure of record is deemed sorely lacking for the entire scope of the claimed product as currently presented in claim 7.
Appropriate correction is required.
NOTE: 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 7, 9 and 16-21 (as currently amended) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trotter et al (2010; CN 101889209 A, English translation previously made of record).
Claim 7 as currently amended is reproduced below:
It is noted that the preamble of claim 7 has been amended to now recite the limitations “for improving rainfastness of a protein on a surface of a plant characterized in that…”, which does not define any specific protein suitable for the intended use/purpose disclosed for imparting the recited characteristic of “rainfastness” of said protein on a given plant surface, and therefore has been taken herein as an intended use limitation that does not provide any distinct structural feature for the claimed formulation per se.
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See also limitations of dependent claims 9 and 16-21, as presented.
Trotter et al (2010) disclose a composition in the form of a liquid suspension comprising a protein (a monoclonal antibody; see [0153], claims 1, 21 and 28, for instance) at 1 mg/ml concentration (i.e. 0.1 wt% of the protein; see [0157]), a pH buffering agent (such as 10mM sodium acetate, pH 5.0; i.e. 0.82 wt% taken as for anhydrous sodium acetate), and an organic polysiloxane (polydimethylsiloxane; see [0063]-[0068], [0074]-[0075], for instance) in an amount of about 0.5 wt% (see [00153]) in the final suspension. Thus, Trotter et al reasonably discloses the same composition as recited in instant claims 7, 9 and 16-21.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
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.
1. Claims 7-12 and 16-26 (as presented) are rejected under 35 U.S.C. 103 as being unpatentable over Deising et al (2019; NPL cited in IDS dated 12/06/2023, citation no. 2; also cited by IPER submitted by applicants) taken with Humble et al (US 2003/104944 A1; cited in IDS dated 12/06/2023), Tsujibo et al (2003; NPL cited as ref. [U] on PTO 892 form), and Sjoeholm et al (US 6,855,548 B2; cited as ref. [A] on PTO 892 form)].
Claim 7 as amended by applicants has been reproduced as follows:
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See also limitations of dependent claims 8-12 and 16-26 as currently presented.
Deising et al (2019), while teaching modern fungicides and antifungal compounds (see Title, and section "Bifunctional Fusion Peptides and Microgel-Based Release Systems for Plant Health" on p. 239-247; esp. disclosure on p. 242-243, section “Discussion”, and Figure 1), disclose improvement of the rainfastness of aqueous solution of purified pesticidal proteins sprayed on plant surfaces (see p. 240, last paragraph); wherein they disclose the fact that “alternative approaches for crop management are needed. We showed that THA and LCI, two natural peptides, can be used as adhesion promoters to immobilize proteins or peptides (e.g. eGFP, DS01) to leaves of soybean, barley and corn”; wherein the binding through hydrophobic interaction provides anchoring that resists washing and rain without affecting plant physiology (see p. 243, 1st paragraph); wherein they “…expect that bifunctional peptides or proteins consisting of plant-sticking anchor peptides and pesticidal peptides or proteins can be used to fight essentially any pest and disease in a rainfast manner” (see p. 243, 2nd paragraph); wherein they “demonstrate that the amphiphilic peptide thanatin (THA), upon spray application, sticks enhanced green fluorescent protein (eGFP) (Zimmer 2002) to the surface of soybean leaves in a rainfast manner. We also report that a bifunctional fusion peptide, DS01-THA, inhibits the germination of P. pachyrhizi spores in vitro and alleviates SBR symptoms on soybean plants” (see p. 240, 2nd paragraph). Therefore, they disclose aqueous composition comprising amphipathic peptides and their role in anchoring of proteins on the surface of leaves to improve rainfastness of the protein (see section “Peptide-Mediated Anchoring Withstands Rain” on p. 241) that is demonstrated to be efficient in it antifungal effect in reducing SBR (soybean rust; see p. 240, 2nd paragraph; p. 242, section “A DS01-THA Fusion Peptide Alleviates SBR”, and Figure 1).
However, a composition for improving rainfastness of a protein on a plant surface that -1) comprises an organo-modified siloxane (such as organo-modified trisiloxane; see limitations of instant claims 8-10 and 22-25); and 2) wherein the protein is an enzyme, serine peptidase (such as the elected species of the protein having SEQ ID NO: 42, a protease derived from Nocardiopsis sp.; see limitations of instant claims 11, 12 and 26) with a pH control component (see limitations of instant claims 7, 20 and 21), have not been explicitly disclosed by the teachings and/or suggestion from Deising et al, as discussed above.
Humble et al (2003), while teachings the use of non-spreading silicone in agrochemical compositions for increasing the rainfastness of the composition (see Title, Abstract, and [0002]-[0006], [0042]-[0044], for instance), demonstrate the fact that rainfastness of aqueous spray solutions (0.1% v/v adjuvants) comprising agrochemical compositions (that cover insecticides, fungicides, herbicides, plant growth regulators, biologicals, and other plant nutrients) can be improved when organosilicone surfactants such as BREAK-THRU®, SILWET® L-77, or surfactants A and B (see Examples 1-3, and [0080]-[0085]) are used; and wherein the silicone surfactants are organo-modified siloxanes encompassing the organo-modified trisiloxanes and polysiloxanes that comprise of polyether groups, and trisiloxane ethoxylates (as recited in the instant claims 8-10 and 22-25; it is noted that applicants have employed the same organo-modified siloxanes in the aqueous spray formulation, such as BREAK-THRU®, SILWET® L-77; see instant SPEC, starting on p. 165, Examples 1-3).
It is noted that the aqueous liquid formulation that comprises an enzyme protein such as a serine peptidase (elected species of the protein having SEQ ID NO: 42, a serine endopeptidase derived from Nocardiopsis sp.; see limitations of instant claim 12, in particular) has not been specifically exemplified by the agrochemical spray formulations containing organo-modified siloxanes disclosed by Humble et al.
However, such would have been obvious to an artisan of ordinary skill in the art of such agricultural formulations because Tsujibo et al (2003) already disclosed the fact that soil bacteria such as alkaliphilic Actinomycetes (such as Nocardiopsis sp. ; see Tsujibo et al, Abstract, and p. 894, left column, 2nd paragraph; and cited references #14-17 therein) that grow best under alkaline conditions and synthesize/produce several extracellular hydrolytic enzymes (including lipases, nuclease, proteases including chitinases, etc.) to obtain nutrients and energy by solubilizing polymeric compounds in the soil, and have been shown to impart significant antifungal effects.
Also, Sjoeholm et al (2005) disclose the protease produced by Nocardiopsis sp. (designated as an acid-stable, serine protease having SEQ ID NO: 1) that has optimal activity at or close to neutral or more alkaline pH ranges between pH 7-11 and also significantly thermostable, albeit used as an animal feed additive (see Abstract, Figure 2, and columns 2, 5-6, 13, for instances), wherein the protease produced by Nocardiopsis sp. is 100% identical to SEQ ID NO: 42 (applicant’s elected species for instant claim 12) as reproduced below:
Sequence Alignment:
Issues patents database results for SEQ ID NO: 42:
RESULT 1
US-09-779-323A-1
(NOTE: this sequence has 19 duplicates in the database searched.
See complete list at the end of this report)
Sequence 1, US/09779323A
Patent No. 6855548
GENERAL INFORMATION
APPLICANT: Sjoeholm, Carsten
APPLICANT: Oestergaard, Peter
TITLE OF INVENTION: Use of Acid Stable Protease in Animal Feed
FILE REFERENCE: 10094.200-US
CURRENT APPLICATION NUMBER: US/09/779,323A
CURRENT FILING DATE: 2003-05-09
NUMBER OF SEQ ID NOS: 2
SEQ ID NO 1
LENGTH: 188
TYPE: PRT
ORGANISM: Nocardiopsis sp. NRRL 18262
Query Match 100.0%; Score 1006; Length 188;
Best Local Similarity 100.0%;
Matches 188; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ADIIGGLAYTMGGRCSVGFAATNAAGQPGFVTAGHCGRVGTQVTIGNGRGVFEQSVFPGN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ADIIGGLAYTMGGRCSVGFAATNAAGQPGFVTAGHCGRVGTQVTIGNGRGVFEQSVFPGN 60
Qy 61 DAAFVRGTSNFTLTNLVSRYNTGGYATVAGHNQAPIGSSVCRSGSTTGWHCGTIQARGQS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DAAFVRGTSNFTLTNLVSRYNTGGYATVAGHNQAPIGSSVCRSGSTTGWHCGTIQARGQS 120
Qy 121 VSYPEGTVTNMTRTTVCAEPGDSGGSYISGTQAQGVTSGGSGNCRTGGTTFYQEVTPMVN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VSYPEGTVTNMTRTTVCAEPGDSGGSYISGTQAQGVTSGGSGNCRTGGTTFYQEVTPMVN 180
Qy 181 SWGVRLRT 188
||||||||
Db 181 SWGVRLRT 188
Thus, to a person of ordinary skill in the art, it would have been obvious to employ (and or substitute) antimicrobial biological such as the protease derived from Nocardiopsis sp. (as disclosed for their antifungal activity by Tsujibo et al when taken with the disclosure from Sjoeholm et al) as an alternative agent which can be formulated in the form of an aqueous composition comprising suitable amount of the organo-modified siloxanes (as disclosed by Humble et al, discussed above) with suitable pH range buffers that can be sprayed on plant surfaces for improving the rainfastness of the antifungal protease, with a reasonable expectation of success, as already suggested and/or demonstrated for other agrochemical compositions used by Deising et al when taken with the detailed disclosure form Humble et al. Since, the proteases from Nocardiopsis sp. have been known in the art to be stable under broad pH range, and have demonstrated antifungal properties, an artisan of ordinary skill in the art of agricultural formulations would have been motivated to employ such beneficial protease in the aqueous spray formulation along with stabilizing amounts of the organo-modified siloxanes in order to obtain an effective formulation for agricultural use, as already suggested by the combined teachings from Deising et al when taken with Humble et al as discussed above, unless evidence/data provided on record to the contrary. It is noted that instant claims (see instant claims 7, 12 and 26 as presented) are not limited to any specific enzyme protein, fragment, mutant or variant, etc., nor they are specific to any particular type of buffer, pH range, or other components of the liquid formulation, and therefore, the disclosure from the combined teachings and suggestions from the cited prior art references as discussed above is deemed pertinent, unless evidence/data provided on record to the contrary, which is currently lacking for the scope of the invention as claimed. It is noted to applicants that the scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data is not commensurate in scope with the degree of protection sought by the claim (see instant claim 7, in particular).
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
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