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 .
Claims 6-12 and 20-25, pending in this application, are examined.
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) and 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/341, 498, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. 6-12 and 20-25 that recite the limitations pyoverdine and pyochelin have no basis in prior art filed applications. Therefore, the effective filing date of the claims that recite pyoverdine and pyochelin is considered to be 05/01/2024, for prior art purposes.
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 21-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) an antimicrobial composition comprising pyoverdine, 2,4-diacetylphloroglucinol (2, 4-DAPG), pyochelin, pyoluteorin, or combinations thereof from naturally occurring Pseudomonas strains. This judicial exception is not integrated into a practical application because the biosynthetic product is the only composition recited in the claim. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the pyoverdine, 2,4-diacetylphloroglucinol (2, 4-DAPG), pyochelin, and/or pyoluteorin are the only components in the composition recited in the claim that are not "markedly different" in terms of the "product's structure, function, and/or other properties from the pyoverdine, 2,4-diacetylphloroglucinol (2, 4-DAPG), pyochelin, or pyoluteorin that is naturally present in Pseudomonas sp . The MPEP 2106 states “… product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart”. See also Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (although claims 7, 8, 13 and 14 recited an inoculant comprising a bacterial mixture and a powder base, only the bacterial mixture was analyzed)”.
Thomashow et al (Manual of environmental Microbiology (1997):493-499) teach natural microorganisms in natural environment such as soil produce antibiotics including pyoverdine, 2,4-diacetylphloroglucinol (2, 4-DAPG), pyochelin, pyoluteorin that contribute to microbial antagonism and persistence. Raaijmakers et al (Annu Rev. Phytopathol (2012) 50:403-424; Applicant’s IDS) teach that the genus Pseudomonas comprises species and strains that produce secondary metabolites including 2,4-diacetylphloroglucinol (2, 4-DAPG), a phenolic antibiotic produced by different Pseudomonas species, exhibits antifungal and antibiotic activities pyrrolnitrin, and other antibiotic compounds that suppress plant pathogens and promote plant growth (see, for example, the paragraph bridging columns 1 and 2 of page 407). The “agricultural composition” of claim 25, is defined in the specification as a composition that is applied to agriculture which does not render the claim patent eligible. Therefore, the claims are directed to nature-based product.
Claim Rejections - 35 USC § 102
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 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 21-22 and 25 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raajimakers et al (Annu Rev. Phytopathol (2012) 50:403-424) in light of Thomashow et al (Manual of environmental Microbiology (1997):493-499) .
The claims are drawn to an antimicrobial composition comprising one or more of pyoverdine, 2,4-diacetylphloroglucinol (2, 4-DAPG), pyochelin, pyoluteorin, wherein the composition is an agricultural composition.
Raajimakers et al teach an antimicrobial composition comprising pyoluteorin and 2,4-DAPG produced from a Pseudomonas sp., said composition suppresses plant pathogens and promote plant growth (see, for example, the paragraph bridging columns 1 and 2 of page 407). At Table 1, Raajimakers et al teach the pyoluteorin and 2, 4-DAPG are obtained from Pseudomonas protegens strain CHAO present in soil-and plant associated environment, so both are present together in agricultural field as a composition (see also Table 2 and Fig. 1). At page 20 of the instant specification, Applicant states that the Pseudomonas protegens strain PBL3 has a 16S rRNA sequence that is 99% identical to the Pseudomonas protegens strain CHAO of the prior art. At Table 1, Raajimakers et al teach the pyoluteorin and multiple other metabolites are from Pseudomonas protegens strain CHAO. Thomashow et al, cited in Raaijmakers et al, provides evidence for a composition comprising the antibacterial metabolites pyoluteorin, siderophores, phenazines, gluconic acid, and 2,4-DAPG, produced by a Pseudomonas sp. See Tables 1-3. Therefore, Raaijmakers et al in light of Thomashow et al teach all claim limitations.
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, 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.
Claims 6-12 and 20-25 and are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al (Frontiers in Microbiology (2016), Vol. 7, article 382; Applicant’s IDS) in view of Raajimakers et al (Annu Rev. Phytopathol (2012) 50:403-424; Applicant’s IDS); Buysense et al (Applied and Environmental Microbiology (1996):865-871) and Mizobucchi et al (Breed Sci (2018):413-419; Applicant’s IDS).
The claims are drawn to an antimicrobial composition comprising two or more of pyoverdine, 2,4-diacetylphloroglucinol (2, 4-DAPG), pyochelin, pyoluteorin, wherein the composition is an agricultural composition and a method of inhibiting the growth of microorganisms including bacterium or a fungus by contacting the microorganism with said antibacterial composition thereby inhibiting its growth on a rice plant; wherein the contacting is carried out before flowering or during panicle formation; wherein the contacting is spraying, or contacting with an effective amount of the product; wherein the contacting is carried out by spraying or dusting the plant , the composition is an agricultural composition; and wherein the microorganism is Burkholderia glumae.
Ma et al teach a method of controlling fungal and/or bacterial disease in various plant species using antimicrobial composition comprising metabolites obtained from Pseudomonas strains that produce multiple antibiotics such as pyoluteorin, phenazines and pyrrolnitrin. Ma et al also teaches a method of reducing blast disease in rice seed or seedlings by spraying a composition comprising an effective amount of metabolite Orfamides obtained from a Pseudomonas strain on the seed or seedling, wherein the Orfamides inhibit appressoria formation in the rice blast Magnaporthe oryzae, thereby reducing severity of blast disease on rice plant at five-leaf stage. See the whole document.
Ma et al does not teach an antimicrobial composition comprising two or more of pyoverdine, 2,4-diacetylphloroglucinol (2, 4-DAPG), pyochelin, and pyoluteorin.
Raajimakers et al in light of Thomashow et al teach an antimicrobial composition comprising pyoluteorin, 2,4-DAPG and siderophores produced from a Pseudomonas sp., said composition suppresses plant pathogens and promote plant growth as discussed above.
Buysense et al teach two siderophore compounds, pyoverdine and pyochelin produced by the growth promoting Pseudomonas aeruginosa strain 7NSK2 that is publicly available, and have a known role in controlling Pythium- induced post-emergency damping off and root-rot of several crops (Figs. 2-3). Buysense et al show that the pyochelin and pyoverdine can function interchangeably to achieve high levels of protection against Pythium-induced damping off and against other plant fungal pathogens (see the whole document).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of controlling plant bacterial and fungal pathogens using secondary metabolites 2,4-diacetylphloroglucinol (2, 4-DAPG) and pyoluteorin from Pseudomonas strains that produce multiple metabolites with known antibacterial and/antifungal properties as taught by Ma et al, and to modify that method by further incorporating other known secondary metabolites and siderosphores pyochelin and pyoverdin from Pseudomonas strains taught by Buysense et al, to obtain combined effects to effectively control phytopathogens including bacterium and fungus in plants including rice as taught by Ma et al, and as suggested by Raaijmakers et al in light of Thomashow et al cited therein. One would have been motivated to use multiple secondary metabolites from a Pseudomonas sp to control pathogens including Burkholderia glumae in important crop species such as rice, given their extensive study and availability for use against plant pathogens as taught by each of Ma et al, and Buysense et al et al. One would have a reasonable expectation of success to use an effective amount of the metabolite to any plant or plant part via spraying at any particular stage of plant growth including before flowering or during panicle formation, depending upon the plant species and the particular disease to control. With regard to claims directed to controlling Burkholderia glumae in rice, it is noted that problems of bacterial panicle blight caused by Burkholderia glumae and how to control are well established in the prior art, as evidenced by Mizobucchi et al (2018). Mizobucchi et al state “[s]serious problems are occurring due to bacterial grain rot (BGR) and bacterial seedling rot (BSR) in seed production fields and nursery facilities in Japan” and in many parts around the world. Therefore, it would also have been obvious to one of skill in the art to target the bacterial blight disease and grain/seedling diseases with the secondary metabolites including pyoverdine, 2,4-diacetylphloroglucinol (2, 4-DAPG), pyochelin, and pyoluteorin, given the success with other seed/seedling rot disease in other plant species as taught by each of Ma et al and Buysense et al. Applicant provides no evidence of unexpected results from using known antimicrobial metabolites from known Pseudomonas sp. having known growth promoting activities to control known diseases in important crops.
Therefore, for all reasons discussed above, the claimed invention is a prima facie case of obviousness, absent evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 6-12, 20-21 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,999,963 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the application and the issued patent are drawn to a method of inhibiting the growth of Burkholderia glumae by contacting, spraying or dusting the plant with a composition comprising pyoluteorin from Pseudomonas strain, wherein the contacting is carried out before flowering or during panicle formation, and wherein the plant is a rice plant. The claims of instant application are drawn a method of inhibiting the growth of microorganisms including bacterium or a fungus by contacting the microorganism with an effective amount of antibacterial composition comprising one or more of pyoverdine, 2,4-diacetylphloroglucinol (2, 4-DAPG), pyochelin, pyoluteorin thereby inhibiting its growth on a plant; wherein the contacting is carried out before flowering or during panicle formation; wherein the plant is rice and microorganism is Burkholderia glumae. The claims of the instant application are broader in scope than the claims of the issued patent drawn to a method of inhibiting the growth of Burkholderia glumae by contacting, spraying or dusting the plant with a composition comprising pyoluteorin from Pseudomonas strain, wherein the contacting is carried out before flowering or during panicle formation, and wherein the plant is a rice plant. Instant claims 21 and 25, drawn to an antimicrobial composition pyoluteorin is obvious over the method of using it of the issued patent. Therefore, the claims of the instant application are genus encompassing the claims of the issued patent.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 6-12 and 20-25 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-4 and 7-30 of copending Application No. 19/232, 589 (reference application). Instant claims 21-24 are identical to claims 1-4 of the copending application. Claim 25 is identical to claim 7 of the copending application, while instant claims 6-12 and 20 are identical to claims 8-15 of the copending application.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Relevant Arts Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yasmin et al (PLOS one (2016; Applicant’s IDS). Yasmin et al biological control of bacterial leaf blight in rice by inoculated bacteria.
Conclusion
No claim is allowed.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/Primary Examiner, Art Unit 1662