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 .
Claim Status
The amended claim set filed 11 Nov 2024 is acknowledged. Claims 1-4, 6-9, 13-15, and 23-24 are currently pending. Of those, claims 1-4, 6-9, and 13-15 are currently amended, and claims 23-24 are new. Claims 5, 10-12, and 16-22 are cancelled. Claims 1-4, 6-9, 13-15, and 23-24 will be examined on the merits herein.
References to the Specification
The instant specification does not include paragraph numbers. To avoid ambiguity if future amendments to the specification change the page and line numbers where information is located, in this action references to the specification will use paragraph numbers from the Pre-Grant Publication US-20250212889-A1 (PTO-892).
Priority
The application claims priority to foreign priority document KR10-2022-0039717 (filed 30 Mar 2022) and is a 371 of PCT/KR2023/004170 (filed 29 Mar 2023). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The non-English foreign priority document cannot be reviewed for whether it supports the claimed subject matter. The effective filing date used for searching the art is 29 March 2023 for all claims.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 27 Sep 2024 and 29 Oct 2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show a difference between different samples in Figure 9B as described in the specification at [0181]. The figure is copied below; the difference between the different samples is not apparent. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
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Examiner’s view of Figure 9B.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings submitted 27 Sep 2024 include pictures that appear to have originally been taken in color. This information is provided in case applicant would like to submit color photographs. The examiner is not requiring that color photographs be submitted (unless that is the only way to overcome the objection above). Applicant is informed that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claims 1, 2, 4, and 9 are objected to because of the following informalities: scientific names for microbes should be italicized to match the conventions in the art at the time of filing. For example, Bacillus amyloliquefaciens. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 2 and 9 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 the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the parenthetical phrase “(bacterial speck)” appears to be functioning similar to the phrase "for example", and renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In the interest of compact prosecution, the limitation will be interpreted in this action as optional.
Regarding claim 9, the claim scope is ambiguous because grouping of the three objects is unclear. The claim recites “the composition comprising any one or more of the Bacillus amyloliquefaciens microorganism of claim 15 or a culture thereof, and valine”. It cannot be clearly determined whether the composition comprises “(a) bacteria or culture and (b) valine”, or whether it comprises “(a) bacteria or (b) culture and valine”. In the interest of compact prosecution, the claim will be interpreted in this action as the first option to be consistent with the product disclosed in claims 6 and 23-24.
Claim Rejections - 35 USC § 112(a)
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 1-4, 6-9, 13-15, and 23-24 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) contains 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.
It is apparent that Bacillus amyloliquefaciens microorganism which is deposited with Accession No. KCCM13138P is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the bacteria.
The specification does not disclose how to obtain this isolate, other than referencing the deposit at [0125]. The process disclosed in the specification is not repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. The claim requires using the specific deposited isolate, either directly or to generate culture for the invention.
It is noted that Applicants have deposited biological material but there is no indication in the specification as to public availability. Therefore, a deposit at a recognized depository may be made to obviate this rejection.
The deposit was made under the terms of the Budapest Treaty (see specification [0125]), so a statement, affidavit or declaration by Applicants, or 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 deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
Claims 1-4, 6-9, 13-14 and 23-24 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 claimed invention.
MPEP 2163 states:
An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate").
Claims 1-4, 6-8, 13-14, and 23-24 each recite methods of administering a culture of B. amyloliquefaciens that has the result of achieving functional effects on a plant (“enhancing resistance to a plant disease”, “induces systemic induced resistance of the plant body”, “induces plant growth of the plant body”, “preventing or treating a plant disease”, “controlling a plant disease”). Also, claim 9 recites a product comprising a culture of B. amyloliquefaciens KCCM13138P that has the intended result of achieving functional effects on a plant (“composition for controlling a plant disease”).
The specification does not describe how to use the claimed culture in order to achieve the claimed effects. The specification defines that the culture does not have to comprise the specific microorganism, and may instead be an extract, filtrate, or lysate [0035]. The amount of culture applied to a plant is a fixed dose, unlike live bacteria that can replicate to reach an effective dose. When teaching the doses of composition to use, the specification uses the term “CFU” (colony forming unit) [0102], but this teaching is not relevant to cultures that do not comprise viable B. amyloliquefaciens. The examples describe the use of live B. amyloliquefaciens KCCM13138P in different plants and different formulations to prevent and treat different diseases, but the examples do not demonstrate any applications of a B. amyloliquefaciens culture that has any effect. The specification and examples also do not identify any active components of the B. amyloliquefaciens KCCM13138P culture that are responsible for the claimed effect.
The specification is not required to teach features that were well known in the art at the time of filing. From MPEP 2163: “What is conventional or well known to one of ordinary skill in the art need not be disclosed in detail. See Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d at 1384, 231 USPQ at 94. See also Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1085 (Fed. Cir. 2005).”
It was known in the art that at least some B. amyloliquefaciens culture filtrates can have the claimed effects at least at some concentrations. For example, Yoshida et al. (2001; PTO-892) teaches that cell-free culture filtrate of Bacillus amyloliquefaciens strain RC-2 inhibited disease on mulberry leaves, indicating that suppression was due to antifungal compounds in the filtrate, and also inhibited the growth of several other phytopathogenic fungi and bacteria, such as Rosellinia necatrix, Pyricularia oryzae, Agrobacterium tumefaciens, and Xanthomonas campestris pv. campestris, in vitro (Abstract). Yoshida et al. teaches that seven kinds of antifungal compounds were isolated from the culture (Abstract). Yoshida also teaches that the effect of the culture filtrate depends on the dose administered, as different dilutions of the culture filtrate inhibit the pathogens to different extents (Table 1).
In summary, the only structure that was correlated with the claimed functions in the specification is the presence of the live bacteria itself. The claimed “culture” product is broader than products comprising the art-known anti-microbial compounds, and the specification does not demonstrate that the art-known anti-microbial compounds are actually present in the culture(s) produced by the claimed strain. So the art cannot provide a “culture” structure that is correlated with the claimed function. Also, there are no species of composition/method using the culture product that are described in detail in the specification as having the claimed function, so there is not a detailed description of a representative number of species within the claimed genera.
When evaluating the specification in the context of the prior art at the time of filing, one having ordinary skill in the art at the time of filing would have concluded that the specification demonstrated possession of methods of administering live B. amyloliquefaciens KCCM13138P to achieve effects in plants related to disease resistance, prevention, and treatment, but have not demonstrated possession of methods of administering cultures that do not comprise live B. amyloliquefaciens KCCM13138P. Therefore, claims 1-4, 6-9, 13-14 and 23-24 are rejected for failing to demonstrate possession of the claimed invention.
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 9 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more.
Claim 9 recites “A composition for controlling a plant disease, the composition comprising any one or more of (a) the Bacillus amyloliquefaciens microorganism of claim 15 or a culture thereof, and (b) valine.” Claim 15 recites “A Bacillus amyloliquefaciens microorganism which is deposited with Accession No. KCCM13138P.” (Step 1: yes, a product)
There is a natural isolate corresponding with the deposited strain because B. amyloliquefaciens strains are initially isolated from nature and cannot be human-created in a lab from non-living chemicals. For example, Yoshida et al. (2001; PTO-892) teaches that Bacillus amyloliquefaciens strain RC-2 was isolated from mulberry leaves (pg. 181 col. 2 par. 1) and Taghavi et al. (US-20160183537-A1; PTO-892) teaches that Bacillus amyloliquefaciens RTI472 was isolated from the root of American ginseng [0047]. Therefore, the natural isolate of the deposited strain is a nature-based product and a markedly-different characteristics analysis is performed as in MPEP 2106.04(c). The instant specification does not teach any modifications that were made to B. amyloliquefaciens KCCM13138P relative to the original natural isolate that result in markedly different characteristics. Instead, the specification states only that 16 strains of Bacillus were screened to identify the strain with the best effect on the Ps pathogen [0120, Example 1]. MPEP 2106.04(c) states that markedly different characteristics must be claimed (“The court noted that the alleged phenotypic differences (e.g., the fact that Dolly may have been taller or heavier than her donor) could not make the clones markedly different because these differences were not claimed. 750 F.3d at 1338, 110 USPQ2d at 1672. See also Roche Molecular System, Inc. v. CEPHEID, 905 F.3d 1363, 1370, 128 USPQ2d 1221, 1226 (Fed. Cir. 2018) (alleged structural differences between linear primers and their counterparts on a circular chromosome were neither claimed nor relevant to the eligibility inquiry).”) Therefore, the deposited B. amyloliquefaciens KCCM13138P strain of claim 15 does not have any markedly different characteristics relative to the natural strain that are both disclosed and claimed, and is a natural product. (Step 2A Prong 1: yes, recites a natural phenomenon).
The composition of claim 9 recites that the composition also comprises valine. The amount of valine is not claimed and could be any trace amount of valine. Tian et al. (2021; PTO-892) teaches that valine is an amino acid and that Bacillus amyloliquefaciens contains genes for biosynthesis of valine (pg. 5 col. 2 par. 1). Therefore, a composition that comprises B. amyloliquefaciens KCCM13138P, which is a natural product by the analysis above, also comprises valine in the cells and in any proteins or amino acids that are secreted. (Step 2A Prong 1: yes, recites a natural phenomenon).
This judicial exception is not integrated into a practical application because the claims require nothing more than the bacteria that is not markedly different from a natural product; there are no additional elements (Step 2A Prong 2: no, not integrated). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims require nothing more than the bacteria that is not markedly different from a natural product; there are no additional elements (Step 2B: no, significantly more).
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-4, 6-9, 13-14, 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshida et al. (2001; hereafter Yoshida; PTO-892) as evidenced by GRiSP Research Solutions (2016, “Bacteriological Peptone”; hereafter Peptone MSDS; PTO-892).
Regarding claims 1, 13, 14, Yoshida teaches that cell-free culture filtrate of Bacillus amyloliquefaciens strain RC-2 inhibited disease on mulberry leaves (Abstract) and specifically teaches treating a plant body (mulberry leaves) with a culture of B. amyloliquefaciens (pg. 182 par. bridging cols.). The culture also inhibited the growth of several other phytopathogenic fungi and bacteria, such as Rosellinia necatrix, Pyricularia oryzae, Agrobacterium tumefaciens, and Xanthomonas campestris pv. campestris, in vitro (Abstract).
The instant specification defines that the term “culture” does not have to comprise the specific B. amyloliquefaciens KCCM13138P microorganism, and may instead be a culture extract, filtrate, or lysate produced by culturing the microorganism [0035]. Therefore, the instant “culture” is interpreted as a product by process. The Yoshida B. amyloliquefaciens culture filtrate appears to be substantially identical to the instant claimed B. amyloliquefaciens culture filtrate because the Yoshida culture filtrate is capable of the claimed disease resistance function and the instant specification does not provide any other identifying characteristics to show that the culture filtrate differs when it is made by the KCCM13138P strain instead of the RC-2 strain. See MPEP 2113: “"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).”
Regarding claim 3, mulberry produces fruits (i.e. a fruit vegetable).
Regarding claim 6, 9, 23-24, the culture media comprises peptone (pg. 181 col. 2 par. 2). The Peptone MSDS provides evidence that peptone comprises valine (“Typical composition of amino acids” table on pg. 1), so it provides evidence that the Yoshida culture comprises at least trace amounts of valine.
Regarding the functions of claims 1-2, 4, 7-9, 13-14, teaches that cell-free culture filtrate of Bacillus amyloliquefaciens strain RC-2 inhibited disease on mulberry leaves, indicating that suppression was due to antifungal compounds in the filtrate, and also inhibited the growth of several other phytopathogenic fungi and bacteria, such as Rosellinia necatrix, Pyricularia oryzae, Agrobacterium tumefaciens, and Xanthomonas campestris pv. campestris, in vitro (Abstract, Table 1).
Yoshida teaches the same, or substantially the same, culture product as is claimed, as discussed above par. 33-34, and there is no evidence that the Yoshida culture product does not have the disclosed functional effects when it is administered to a plant. MPEP 2112.01 states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.”
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 1-4, 6-9, 13-14, 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-11 of copending Application No. 19/603,923 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 1, 13, 14, ‘923 claims 5 and 8 (and dependent claims) teaches a composition for promoting plant growth, comprising, as an active ingredient a culture of a B. amyloliquefaciens strain deposited with accession numbers KCCM13393P or KCCM13394P. ‘923 claims 10-11 teach methods for enhancing plant stress resistance and promoting plant growth comprising treating a plant with a culture of a B. amyloliquefaciens strain deposited with accession numbers KCCM13393P or KCCM13394P.
The instant specification defines that the term “culture” does not have to comprise the specific B. amyloliquefaciens KCCM13138P microorganism, and may instead be a culture extract, filtrate, or lysate produced by culturing the microorganism [0035]. Therefore, the instant “culture” is interpreted as a product by process. The B. amyloliquefaciens culture from the claims of ‘923 appears to be substantially identical to the instant claimed B. amyloliquefaciens culture filtrate because the ‘923 culture is capable of the claimed promoting plant growth function and the instant specification does not provide any other identifying characteristics to show that the culture filtrate differs when it is made by the KCCM13138P strain instead of the KCCM13395P or KCCM13396P strains. See MPEP 2113: “"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).”
Regarding claim 3, ‘923 claims 7 and 9 teach that the plant can be Poaceae (i.e. grains).
Regarding the functions of claims 1-2, 4, 7-9, 13-14, ‘923 claims 8-9 and 11 teach the composition can promote plant growth or the method has the effect of promoting plant growth. Also, the claims of ‘923 teach the same, or substantially the same, culture product as is claimed and there is no evidence that the culture product from the claims of ‘923 does not have the disclosed functional effects when it is administered to a plant. MPEP 2112.01 states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.”
Claims 1-4, 7-8, and 13-14 are anticipated by the claims of ‘923 alone. The claims of ‘923 do not teach that the culture comprises valine, as in claims 6, 9, 23-24.
Regarding claim 6, 9, 23-24, Yoshida teaches culturing B. amyloliquefaciens in a culture media that comprises peptone (pg. 181 col. 2 par. 2). The Peptone MSDS provides evidence that peptone comprises valine (“Typical composition of amino acids” table on pg. 1), so it provides evidence that the Yoshida culture comprises at least trace amounts of valine. Yoshida teaches that when a different B. amyloliquefaciens strain is grown in this culture, it produces compounds that inhibit the growth of phytopathogenic fungi and bacteria (Abstract).
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to improve the generic B. amyloliquefaciens culture product of the claims of ‘923 by using the Yoshida valine-comprising B. amyloliquefaciens culture media, thereby arriving at the claimed invention, because one of ordinary skill in the art would need to choose some specific culture media in order to produce the composition disclosed in the ‘923 claims and the Yoshida media is known to successfully grow B. amyloliquefaciens so that it enhances plant resistance against pathogenic stresses. Therefore the combination would be desirable because using an art-known culture media would reduce the experimentation required to discover the culture conditions for B. amyloliquefaciens. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” This modification could be made with a reasonable expectation of success because Yoshida teaches how to use the media to grow B. amyloliquefaciens and the claims of ‘923 do not include any details on what culture conditions are required.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (the claims of ‘923) teaches a product and method that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the culture media used for B. amyloliquefaciens in place of a generic media); the substituted element (i.e. the valine-containing culture media for B. amyloliquefaciens) was already known and already shown to function as a culture media for B. amyloliquefaciens, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting one media for another with a reasonable expectation of success (i.e. the substitution of the element would lead to predictable results). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 1-4, 6-9, 13-14, 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-11 of copending Application No. 19/604,278 (reference application), either alone or in view of Yoshida et al. (2001; hereafter Yoshida; PTO-892) as evidenced by GRiSP Research Solutions (2016, “Bacteriological Peptone”; hereafter Peptone MSDS; PTO-892). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 1, 13, 14, ‘278 claims 5 and 8 (and dependent claims) teaches a composition for promoting plant growth, comprising, as an active ingredient a culture of a B. amyloliquefaciens strain deposited with accession numbers KCCM13395P or KCCM13396P. ‘278 claims 10-11 teach methods for enhancing plant stress resistance and promoting plant growth comprising treating a plant with a culture of a B. amyloliquefaciens strain deposited with accession numbers KCCM13395P or KCCM13396P.
The instant specification defines that the term “culture” does not have to comprise the specific B. amyloliquefaciens KCCM13138P microorganism, and may instead be a culture extract, filtrate, or lysate produced by culturing the microorganism [0035]. Therefore, the instant “culture” is interpreted as a product by process. The B. amyloliquefaciens culture from the claims of ‘278 appears to be substantially identical to the instant claimed B. amyloliquefaciens culture filtrate because the ‘278 culture is capable of the claimed promoting plant growth function and the instant specification does not provide any other identifying characteristics to show that the culture filtrate differs when it is made by the KCCM13138P strain instead of the KCCM13395P or KCCM13396P strains. See MPEP 2113: “"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).”
Regarding claim 3, ‘278 claims 7 and 9 teach that the plant can be Poaceae (i.e. grains).
Regarding the functions of claims 1-2, 4, 7-9, 13-14, ‘278 claims 8-9 and 11 teach the composition can promote plant growth or the method has the effect of promoting plant growth. Also, the claims of ‘278 teach the same, or substantially the same, culture product as is claimed and there is no evidence that the culture product from the claims of ‘278 does not have the disclosed functional effects when it is administered to a plant. MPEP 2112.01 states: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.”
Claims 1-4, 7-8, and 13-14 are anticipated by the claims of ‘278 alone. Like the rejection of ‘923 above, the claims of ‘278 do not teach that the culture comprises valine, as in claims 6, 9, 23-24. The teachings of the art and the rationale for modifying are the same as in the rejection of ‘923 above.
Conclusion
No claims are allowed.
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AMELIA N DICKENS
Examiner
Art Unit 1645
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
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