DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
Applicants’ preliminary amendment filed 05/14/24 is acknowledged.
Election
2) Applicants’ election filed 05/11/2026 in response to the restriction and the species election requirement mailed 03/11/2026 is acknowledged. Applicants have elected invention I without traverse; and the NRRL No. B-50897 bacterial strain species and its fermentation product species; the pesticide species; the Bacillus amyloliquefaciens D747 second biocontrol species; the Pseudomonas plant pathogen species; and the apple harvested plant part species having reduced decay from Erwinia amylovora species within the elected invention I.
Status of Claims
3) Claims 21, 22, 24, 25 and 27-33 have been canceled via the preliminary amendment filed 05/14/24.
Claims 3, 5, 7, 8, 11, 13-17, 19, 20, 23 and 26 have been amended via the preliminary amendment filed 05/14/24.
Claims 1-20, 23 and 26 are pending.
Claims 4, 11-20, 23 and 26 are withdrawn from consideration as being directed to a non-elected invention or species. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
The examination has been extended to the strawberry harvested plant or plant part species.
Claims 1-3 and 5-10 are examined on the merits.
Drawings
4) Applicants’ drawings filed 10/18/23 are acknowledged.
Information Disclosure Statements
5) Acknowledgment is made of Applicants’ information disclosure statements filed 05/11/26 and 10/18/23. The information referred to therein has been considered and a signed copy is attached to this Office Action.
Priority
6) The instant AIA application, filed 10/18/2023, is the national stage application filed under 35 U.S.C § 371 of PCT/US2022/025346 filed 04/19/2022, which claims the benefit of the US provisional applications 63/176,698 filed 04/19/2021, 63/176,704 filed 04/19/21, 63/192,860 filed 05/25/21, and 63/254,795 filed 10/12/21.
Rejection(s) under 35 U.S.C § 112(a) or Pre-AIA , First Paragraph
7) The following is a quotation 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 35 U.S.C. § 112 (pre-AIA ), first paragraph:
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 the invention.
8) Claim 1 and the dependent claims 2, 3 and 5-10 are rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention, because the specification does not provide evidence that the claimed biological material is (1) known and readily available to the public; (2) reproducible, e.g. sequenced; or (3) deposited.
Instant claim 1 is drawn to a harvested plant or plant part comprising a bacterial strain deposited as NRRL No. B-50897. The harvested plant part further comprises a second biocontrol agent such as Bacillus amyloliquefaciens strain D747 per claim 6. It is apparent that the generically recited ‘a bacterial strain’ and the Bacillus amyloliquefaciens strain D747 are required to practice the claimed invention. As required elements, the specifically claimed strains must be known and be readily available to the public, or obtainable by a reproducible method set forth in the specification. If not so obtainable or available, the enablement requirements of 35 U.S.C § 112(a) may be satisfied by a deposit of the claimed strains at an acceptable depository. With regard to Bacillus amyloliquefaciens strain D747, US 7094592 B2 that is referred to in Applicants’ as-filed specification as well as the art, for example, The Biopesticide Registration Action Document, pages 1-30, 08 December 2011, both document that this strain has been deposited in an acceptable depository. See section ‘Relevant Art’ in this Office Action below. With regard to NRRL No. B-50897, the as-filed specification states that the bacterial strain AIP1620 was deposited with the Patent Depository of the National Center for Agricultural Utilization Research Agricultural Research Service, USDA, 1815 North University Street, Peoria, Illinois 61604, USA on 31 January 2014 and was assigned NRRL No. B-50897. If this deposit have been made under the provisions of the Budapest Treaty, then a statement, an affidavit or declaration by Applicants or assignees having the authority and control over the conditions of the deposit, or a statement by an attorney of record who has a registration number over his or her signature, is required. The statement should state that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced, if viable samples cannot be dispensed by the depository. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each state. The statement should identify the deposited bacterial strain by its depository accession number, establish that the deposited strain is the same as the one described in the specification/claims, and establish that the deposited strain was in Applicants’ possession at the time of filing.
If the deposits are non-Budapest Treaty deposits, then in order to certify that the deposits meet the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicants, by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposits would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depositary for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application. The application must contain: 1) The name and address of the depository; 2) The name and address of the depositor; 3) The date of deposit; 4) The identity of the deposit and the accession number given by the depository; 5) The date of the viability test; 6) The procedures used to obtain a sample if the test is not done by the depository; and 7) A statement that the deposits are capable of reproduction. If the deposits were made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the strains described in the specification as filed are the same as those deposited in the depository. Corroboration may take the form of a showing of a chain of custody from Applicants to the depository coupled with corroboration that the deposits are identical to the biological materials described in the specification and in the Applicants’ possession at the time the application was filed.
Applicants’ attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 C.F.R § 1.801-1.809 for further information concerning deposit practice.
Rejection(s) under 35 U.S.C § 112(b) or Pre-AIA , Second Paragraph
9) 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.
10) Claims 1-3 and 5-10 are 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 inventor or a joint inventor regards as the invention.
(a) Claim 1 is vague and indefinite in the generically recited “a bacterial strain deposited as ....”. It is unclear which precise bacterium or specific bacterial species does it represent.
(b) Claim 2 is ambiguous and indefinite in the limitation “about .... CFU ..... about .... total cells ...”. The term “about” is a relative term, which renders the claim indefinite. What precise CFU or total cells are encompassed within these limitations is unclear. The limitations fail to specifically and unambiguously set forth the metes and bounds of the claim such that a skilled artisan would readily recognize that which is being claimed.
(c) Claims 2, 3 and 5-10 lack sufficient antecedence in the limitation “plant part”. See line 1 of claims 2, 3, 5-7, 9 and 10; and lines 1-2 of claim 8. For sufficient antecedence, it is suggested that Applicants insert the limitation –the-- prior to the above-identified claim limitation.
(d) Claims 2-3 and 5-10, which depend directly or indirectly from claim 1, are also rejected as being indefinite due to the indefiniteness identified supra in the base claim.
Rejection(s) under 35 U.S.C § 102
11) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
12) Claims 1-3, 5 and 7-10 are rejected under 35 U.S.C § 102(a)(1) or 35 U.S.C § 102(a)(2) as being anticipated by WO 2020/247848 A1 (Applicants’ IDS).
WO 2020/247848 A1 disclosed a harvested plant or plant part such as a seed comprising or coated with an effective amount of a combination composition comprising the bacterial strain AIP1620 biocontrol agent or an active variant thereof and one or more synthetic biocide elements such as a pesticide. Said composition comprised a population of biocontrol agent(s). The prior art combination composition comprising at least 106 CFU/g (i.e., about 105 CFU/g) or about 105 CFU/ml to about 1010 CFU/ml was applied simultaneously or sequentially to the plant or the plant part for the control of one or more plant diseases including Apple Scab against Venturia inaequalisa. The prior art composition was applied to apple for treating a plant disease such as Apple Scab. The prior art composition is used against apple curculio. The prior art composition had antipathogenic effects including decreased tissue necrosis and decayed plant tissues. The composition is applied to a plant part such as seeds to control a plant pathogen such as Ewinia amylovora. See claims 21-25, 1-20 and 31-32 and 37; lines 19-24 of page 63; last full paragraph of page 2; page 65 including the last paragraph therein; page 1 including SUMMARY; pages 4, 40 and 49; line 24 of page 67; line 29 of page 68; line 8 of page 31; page 30; paragraph bridging pages 3 and 4; paragraph bridging pages 30 and 31; line 5 of page 33 and the paragraph bridging pages 32 and 33; line 7 of page 37 and the paragraph bridging pages 36 and 37; line 3 of page 37 and the paragraph bridging pages 37 and 38; page 38; 4th and 6th rows from the bottom of page 45 within Table 1; paragraph bridging pages 33 and 34; and the last full paragraph of page 38.
Claims 1-3, 5 and 7-10 are anticipated by WO 2020/247848 A1.
13) Claims 1-3 and 5-9 are rejected under 35 U.S.C § 102(a)(1) or 35 U.S.C § 102(a)(2) as being anticipated by US 20150218568 A1.
US 20150218568 A1 taught a formulation of a biocontrol agent comprising an effective amount such as about 106, 1010 or 109 CFU per gram of the strain deposited as NRRL No. B-50897, a.k.a. AIP1620, and a biocide or a pesticide. US 20150218568 A1 further taught having any biological or biocontrol agent including the bacterial strain Bacillus amyloliquefaciens D747 in the formulation comprising therein the strain NRRL No. B-50897. US 20150218568 A1 taught a seed (i.e., a plant part) or a crop applied with the formulation and a method of applying it.
The prior art formulation and the method are for protecting against plant pathogens including Erwinia and Pseudomonas. The prior art formulation and the method resulted in postharvest control of the Grey Mold in strawberries. See sections [0034], [0044], [0041] to [0043], [0053]; [0054]; [0059], [0060], [0063], [0064], [0076] and [0071]; section [0074] including the last full sentence therein; claims 20, 21, 16, 15 and 14; TABLE 10; and Example 7. US 20150218568 A1 taught the importance of the need for biological control agents that have antibiotic effects on various plant pathogens. See sections [0063], and [0003] to [0005].
Claims 1-3 and 5-9 are anticipated by US 20150218568 A1.
Rejection(s) under 35 U.S.C § 103
14) 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 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., 148 USPQ 459, that are applied for establishing a background for determining obviousness under 35 U.S.C § 103(a) 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 unobviousness.
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 at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicants are 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 at the time a later invention was effectively filed 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.
15) Claim 6 is rejected under 35 U.S.C § 103 as being unpatentable over WO 2020/247848 A1 (Applicants’ IDS) as applied to claims 1 and 5 above and further in view of Pethybridge et al. (Plant Health Progress 20: 61-66, published online 22 March 2019).
The disclosure of WO 2020/247848 A1 is set forth supra, which is silent on the presence of another biocontrol agent comprising Bacillus amyloliquefaciens strain D747.
However, Pethybridge et al. taught the Bacillus amyloliquefaciens D747 strain, i.e., the Double Nickel LC recited in the instant application, as a biocontrol agent for controlling plant pathogens. Pethybridge et al. taught of the efficacy and robustness of a composition comprising the Bacillus amyloliquefaciens D747 biopesticide, i.e., a biocontrol agent, with or without a pesticide such as Proconazole or Boscalid for management of a plant disease. Said composition significantly reduced the incidence of white mold disease on plants and plant parts such as pods. See title; Abstract; last full sentence in left column of page 62; page 64; last full paragraph of page 63; 1st full paragraph of page 65; and Tables 2 and 3.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to have the art-known biocontrol agent or biopesticide such as the Bacillus amyloliquefaciens strain D747 of US 20150218568 A1 in WO 2020/247848 A1’s composition applied to the plant part therein to produce the instant invention since both biocontrol agents were taught for the same purpose of protecting plants and plant parts from disease-causing plant pathogens. It is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. In re Sussman, 136 F.2d 715, 718, 58 USPQ 262, 264 (CCPA 1943); In re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA 1972); In re Susi, 58 CCPA 1074, 1079-80; 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960). In re Kerkhoven, 626 F. 2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose). Furthermore, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007),
discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill.
Claim 6 is prima facie obvious over the prior art of record.
Rejection(s) under 35 U.S.C § 101
16) 35 U.S.C § 101 states:
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.
17) Claims 1-3 and 5-10 are rejected under 35 U.S.C § 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 2 recite a harvested plant or plant part comprising a bacterial strain deposited as NRRL No. B-50897. The harvested plant or plant part of claims 5 and 6 further comprise a second biocontrol agent, for example, Bacillus amyloliquefaciens strain D747. The harvested plant part is an apple, the elected species, per claim 7. Because these elements are composed of matter, at least one embodiment encompassed within the broadest reasonable interpretation (BRI) of instant claims is directed to a statutory category, i.e., a composition of matter (Step 1: YES). The specification refers to AIP1620 as NRRL No. B-50897, which appears to be a naturally occurring bacteria strain. See sections 0019-0021, 0033-34, 0059-60 and Example 1 of US 2015/0218568 A1. Likewise, strain D747 was isolated as a naturally occurring strain from the air in Kikugawa-cho, Ogasa-gun, Shizuoka-ken, Japan as disclosed in lines 50-53 of column 2 of US 7094592 B2 that is recited in Applicants’ as-filed specification. The naturally occurring strain D747 is recognized in the art as a biopesticide. For example, see the teachings of Pethybridge et al. (Plant Health Progress 20: 61-66, published online 22 March 2019) set forth in this Office Action. There is no evidence that these two strains are modified genetically, structurally or in any other way. A plant, or a plant part such as a seed or a pod is also a naturally occurring element. Thus, for at least one embodiment encompassed within the BRI, the claimed plant or plant part, the bacterial strain, and the claimed mixture of NRRL No. B-50897 and the D747 biopesticide do not display markedly different characteristics compared to the naturally occurring counterparts. All of the properties of the claimed strains including the biocontrol function are intrinsic to the strains and are the handiwork of nature inseparable therefrom. Accordingly, each component of the claimed product is a ‘product of nature’ exception, and the claims are directed to judicial exceptions (Step 2A: prong one). Judicial exceptions (JE) include all natural products including those derived from natural sources such as naturally occurring microorganisms, proteins, peptides, polypeptides, and other substances found in or derived therefrom or from nature. Applying such naturally occurring biopesticides to a plant or plant part has been well understood, routine and conventional in the art prior to Applicants’ invention and at the time of filing of the application, so having such naturally occurring elements as recited does not meaningfully limit the claims. With regard to claim 2, merely concentrating a JE does not add an additional element. The instantly claimed product is not integrated into a practical application (Step 2A: prong two). Thus, the claims as a whole add nothing significant beyond the sum of their parts taken separately and do not amount to significantly more than each ‘product of nature’ by itself (Step 2B). The combination of natural products or judicial exceptions does not make the resulting composition patent eligible. See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948). All the components in the claimed product function as they would individually, and a mere mixture or aggregation of natural products do not markedly change the nature-based products from what exist in the natural environment. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions. In sum, instant claims are drawn to judicial exceptions i.e., law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The rationale for this determination is formed in view of the 2019 PEG, the 2015 Update of the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 4618) (hereafter Interim Eligibility Guidance) dated 16 December 2014, the Life Sciences Examples issued in May 2016, and in view of Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June13, 2013).
Double Patenting Rejection(s)
18) 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/patent/patents-forms/. The 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/process/file/efs/guidance/eTD-info-I.jsp.
19) Claims 1-3 and 5 are provisionally rejected on the ground of non-statutory obviousness double patenting as being unpatentable over claims11, 12, 10, 9 and 1 of the co-pending 18555952 application. Although the claims at issue are not identical, they are not patentably distinct from each other. Said claims of the co-pending ‘952 application, drawn to a coated seed comprising a seed and a coating on the seed, the coating comprising a formulation comprising about 105 CFU/gram to about 1012 CFU/gram or CFU/ml of the biocontrol agent bacterial strain AIP1620, i.e., the instantly claimed bacterial strain deposited as NRRL No. B-50897, and another biocontrol bacterial strain agent NRRL B-67089, and a pesticide read on and anticipate instant claims.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
20) Claims 6-9 are provisionally rejected on the ground of non-statutory obviousness double patenting as being unpatentable over claims11, 12, 10, 9 and 1 of the co-pending 18555952 application as applied to claims 5 and 1 supra and further in view of US 20150218568 A1.
The disclosure of the co-pending 18555952 application are set forth supra which is silent on the presence of another biocontrol agent comprising Bacillus amyloliquefaciens strain D747 and on the limitations of instant claims 7-9.
However, US 20150218568 A1 taught a formulation of a biocontrol agent comprising an effective amount such as about 106, 1010 or 109 CFU per gram of the strain deposited as NRRL No. B-50897, a.k.a. AIP1620, and a biocide or a pesticide. US 20150218568 A1 further taught having any biological or biocontrol agent including the bacterial strain Bacillus amyloliquefaciens D747 in the formulation comprising therein the strain NRRL No. B-50897. US 20150218568 A1 taught a seed (i.e., a plant part) or a crop applied with the formulation and a method of applying it. The prior art formulation and the method are for protecting against plant pathogens including Erwinia and Pseudomonas. The prior art formulation and the method resulted in postharvest control of the Grey Mold in strawberries. See sections [0034], [0044], [0041] to [0043], [0053]; [0054]; [0059], [0060], [0063], [0064], [0076] and [0071]; section [0074] including the last full sentence therein; claims 20, 21, 16, 15 and 14; TABLE 10; and Example 7. US 20150218568 A1 taught the importance of the need for biological control agents that have antibiotic effects on various plant pathogens. See sections [0063], and [0003] to [0005].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to have the art-known biocontrol agent or biopesticide such as the Bacillus amyloliquefaciens strain D747 of US 20150218568 A1 in the formulation of the co-pending ‘952 application used to coat the plant part therein to produce the instant invention since both biocontrol agents were taught for the same purpose of protecting plants and plant parts from disease-causing plant pathogens. It is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. In re Sussman, 136 F.2d 715, 718, 58 USPQ 262, 264 (CCPA 1943); In re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA 1972); In re Susi, 58 CCPA 1074, 1079-80; 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960). In re Kerkhoven, 626 F. 2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose). Furthermore, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. Furthermore, given the teachings of US 20150218568 A1, it would have been prima facie obvious to apply the formulation of the co-pending ‘952 application to a plant part comprising apple against plant pathogens including Erwinia and Pseudomonas for the expected benefit of protecting against such plant pathogens.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
21) Claim 10 is provisionally rejected on the ground of non-statutory obviousness double patenting as being unpatentable over claims11, 12, 10, 9 and 1 of the co-pending 18555952 application as applied to claims 9, 8 and 1 supra as modified by US 20150218568 A1 and further in view of WO 2020/247848 A1 (Applicants’ IDS).
The disclosure of the co-pending 18555952 application as modified by US 20150218568 A1 are set forth supra which is silent on the Erwinia plant pathogen being Erwinia amylovora.
However, WO 2020/247848 A1, as set forth supra, taught applying a composition a combination composition comprising the bacterial strain AIP1620 biocontrol agent or an active variant thereof and one or more biocide elements such as a pesticide to a harvested plant or plant part such as a seed or coating a seed with an effective amount of said composition to control a plant pathogen such as Erwinia amylovora.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to have the formulation of the co-pending ‘952 application as modified by US 20150218568 A1 to coat the plant part therein against Erwinia amylovora plant pathogen to produce the instant invention for the purpose of providing protection against the amylovora species of the plant pathogen Erwinia.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Relevant Art
22) The art made of record and not relied upon in any of the rejections is considered pertinent to Applicants’ disclosure:
t US 7094592 B2 disclosed the following:
...., the Bacillus sp. D747 strain (hereinafter, simply referred to as the “D747 strain”) according to the present invention was deposited at the National Institute of Advanced Industrial Science and Technology, International Patent Organism Depositary as “Bacillus sp. D747 with Accession Number “FERM P-18128’, and was then transferred to be deposited under the Budapest Treaty on Nov. 8, 2002, as “Bacillus sp. D747 with new Accession Number FERM BP-8234.
t The Biopesticide Registration Action Document, pages 1-30, 08 December 2011 disclosed the following with regard to the Bacillus amyloliquefaciens strain D747:
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Conclusion
23) No claims are allowed.
Correspondence
24) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
25) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
July, 2026
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