DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
To expedite the compact prosecution, the Examiner is pursuing the amended claims dated 15 August 2024, in which applicants amended claims 3-4, 6-8, 10-15.
Therefore, claims 1-15 are pending in the application.
Election/Restrictions
Applicants’ election without traverse of Group 1, claims 1-7 and 11-15 drawn to a microorganism with reduced competence in the reply filed on 10 July 2026 is acknowledged.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-7, and 11-15 are under current examination.
Priority
This application was filed 08/15/2024 and is a 371 application of PCT/EP2023/052625 filed on 02/03/2023, which claims benefit to the foreign application EP22157245.6 filed 02/17/2022 and a certified translated copy of the EP22157245.6 filed 08/15/2024 is acknowledged.
Thus, the earliest possible priority for the instant application is 02/17/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/15/2024, 09/24/2024, 10/07/2024, 09/04/2025, and 03/17/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, and the signed PTO-1449 are mailed with this action.
Abstract Objection
The abstract of the disclosure filed 08/15/2024 is objected to because the abstract is only 28words in length, and it is not submitted as a single paragraph. MPEP § 608.01(b)(I)(C) states that "the abstract for a national stage application filed under 35 U.S.C. 371 may be found on the front page of the Patent Cooperation Treaty publication (i.e., pamphlet).
However, MPEP §608.01(b)(I) also sets forth guidelines for the abstract and “the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.” Therefore, instant abstract is considered non-compliant.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Therefore, appropriate correction is required.
Drawing Objections
The subject matter of this application admits illustration by a drawing to facilitate understanding of the invention. Applicant is required to furnish a drawing under 37 CFR 1.81(c). No new matter may be introduced in the required drawing. 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).
Claim Objections
Claims 14-15 is objected to because of the following informalities: .
Claims 14 and 15 contain medical and non-medical aspects. These need to be separated. It is arguably that claim 15 encompasses methods of treatment.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (a)
(Written description)
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 1-5, and 11-15 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 contains subject matter that 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 pre-AIA the inventor, at the time the application was filed, had possession of the claimed invention.
Under the written description guidelines (see MPEP 2163), the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail so that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. 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).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
REQUIREMENTS TO ESTABLISH ACTUAL REDUCTION TO PRACTICE
"In an interference proceeding, a party seeking to establish an actual reduction to practice must satisfy a two-prong test: (1) the party constructed an embodiment or performed a process that met every element of the interference count, and (2) the embodiment or process operated for its intended purpose." Eaton v. Evans, 204 F.3d 1094, 1097, 53 USPQ2d 1696, 1698 (Fed. Cir. 2000).
The same evidence sufficient for a constructive reduction to practice may be insufficient to establish an actual reduction to practice, which requires a showing of the invention in a physical or tangible form that shows every element of the count. Wetmore v. Quick, 536 F.2d 937, 942, 190 USPQ 223, 227 (CCPA 1976). For an actual reduction to practice, the invention must have been sufficiently tested to demonstrate that it will work for its intended purpose, but it need not be in a commercially satisfactory stage of development. See, e.g., Scott v. Finney, 34 F.3d 1058, 1062, 32 USPQ2d 1115, 1118-19 (Fed. Cir. 1994) (citing numerous cases wherein the character of the testing necessary to support an actual reduction to practice varied with the complexity of the invention and the problem it solved). If a device is so simple, and its purpose and efficacy so obvious, construction alone is sufficient to demonstrate workability. King Instrument Corp. v. Otari Corp., 767 F.2d 853, 860, 226 USPQ 402, 407 (Fed. Cir. 1985).
For additional cases pertaining to the requirements necessary to establish actual reduction to practice see DSL Dynamic Sciences, Ltd. v. Union Switch & Signal, Inc., 928 F.2d 1122, 1126, 18 USPQ2d 1152, 1155 (Fed. Cir. 1991) ("events occurring after an alleged actual reduction to practice can call into question whether reduction to practice has in fact occurred"); Fitzgerald v. Arbib, 268 F.2d 763, 765-66, 122 USPQ 530, 531-32 (CCPA 1959) ("the reduction to practice of a three-dimensional design invention requires the production of an article embodying that design" in "other than a mere drawing"); Birmingham v. Randall, 171 F.2d 957, 80 USPQ 371, 372 (CCPA 1948) (To establish an actual reduction to practice of an invention directed to a method of making a product, it is not enough to show that the method was performed. "[S]uch an invention is not reduced to practice until it is established that the product made by the process is satisfactory, and this may require successful testing of the product."). See MPEP 2138.05.
Claim 1 encompasses a genus of any microorganism. However, the specification doesn't have adequate support in the disclosure for any microorganism with reduced competence.
Teachings of the Specification:
The specification discloses that the microorganisms are preferably either naturally occurring microorganisms or spontaneous mutants of such naturally occurring microorganisms or microorganisms which are obtained by another method which is classified as non-GMO (See SPEC Col 2 lns 29-31). Spec Further disclose that the microorganisms according to the invention may be any kind of microorganisms which normally possess natural competence, in particular endospore-forming bacteria and/or nonsporulating bacteria, but in a preferred embodiment of the invention, the microorganisms are endospore-forming bacteria (See SPEC Col 4 lns 35-38). However, specification does not disclose that any microorganism with reduced competence. Therefore, the specification fails to identify any microorganism.
State of the Art at the Time of Filing:
In the prior art Sinderen et al. (Molecular Microbiology (1994) 11(4), 695-703; cited in IDS filed 08/15/2024; hereinafter “Sinderen”) teaches B. subtilis with an insertion in its transcription factor comK gene (abstract). Deletion of comK caused a complete block in competence development which emphasizes the absolute necessity of the comK gene product in this process (p. 700 left hand col. 2nd ¶) and showing that the competence was reestablished using a plasmid-based comK gene, thus proving functionality thereof as a regulator of competence (summary and table 1). Therefore, it is obvious that specific B. subtilis microorganisms will have mutated genes for reduced competence. Furthermore, Sinderen does not teach any microorganism with reduced competence.
Working examples of the specification:
Applicant discloses that the B. velezensis strain CECT 5940 was used, and natural competence induction of this strain was monitored with the help of a modified fluorescent reporter strain. The modified strain encodes a genomic mNeonGreen copy that is controlled by the promotor of the competence gene comGA (Spec Example 1, Col. 20 lns 30-33). Applicant further confirmed the expected complete loss of the mutants' capability of DNA uptake via natural competence. Besides the missing ability to take up DNA by natural competence, the mutants thus obtained possess all characteristics of the parent strain CECT 5940 (Spec Col. 23 lns 6-8). Any embodiments that meet all the limitations of the claim are reduced to practice. However, an actual reduction to practice of an invention directed to claimed genus of any microorganism with reduced competence of instant product is not established at the time of filling and POSITA cannot predictably identify any microorganism with reduced competence. Accordingly, the successful testing of the product of the current invention is not shows reduced to practice, therefore, it is not established that the product is satisfactory. See MPEP 2163(I)-(II) and 2163.02.
MPEP § 2163, besides an actual reduction to practice, Applicant may prove possession of the claimed invention by a showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention. Further, as per MPEP § 2163, “[f]or some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement.”
The quantity of experimentation needed to make or use the invention:
Applicants have claimed a genus of any microorganism with reduced competence; however, SPEC is only indicating the use of B. velezensis strain CECT 5940. The genus of any microorganism with instant product claimed by Applicant cannot be predictably made or used by the ordinary artisan. Such random experimentation to identify any microorganism and is embraced by Applicant's claims is required undue experimentation. Furthermore, functionally defined genus claims can be inherently vulnerable to invalidity challenges for lack of written description support, especially in fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus.
See ABBVIE DEUTSCHLAND GMBH & 2 CO. v. JANSSEN BIOTECH, INC., Appeals from the United States District Court for the District of Massachusetts in Nos. 09-CV-11340-FDS, 10-CV-40003-FDS, and 10-CV-40004-FDS, Judge F. Dennis Saylor, IV. See also Ariad, 598 F.3d at 1351 ("[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011) (noting the technical challenges in developing fully human antibodies of a known human protein).
Conclusion:
With these additional evidence, the product of claimed invention of any microorganism with reduced competence is not well established at the time of filling and the ordinary artisan cannot predictably identify any microorganism. Therefore, one of skill in the art would neither expect nor predict the appropriate product of instantly claimed genus of any microorganism with reduced competence. Furthermore, neither the specification nor the art indicates the ability to identify any microorganism with reduced competence.
Therefore, it concludes that the claimed genus of any microorganism with reduced competence doesn't have an adequate written description. It concludes that a skilled artisan would find the specification inadequately described. Accordingly, the Applicant did not sufficiently possess the broader invention as claimed in claim 1 and dependent claims 2-5, and 11-15.
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 1-5 and 14 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 pre-AIA the applicant regards as the invention
Claim 1, the terminology "reduced competence" is completely unclear. Setting aside the fact that "competence" is itself an unclear term (a microorganism could be e.g. "competent" for growth on a certain carbon source), it is also unclear what the "competence" level is compared to in order to establish that it is reduced. Microorganisms will naturally have a range of "competencies", so depending on which one is taken for comparison, essentially any microorganism can be viewed as having reduced "competence." Therefore, "reduced competence" being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 2 recited "microorganism possesses probiotic activity," which is unclear since the standard needing to be met to designate an organism as probiotic is not clear. The "ability to inhibit pathogenic bacteria" is also unclear since which such bacterium is to be tested and under what conditions? The ability to grow in the presence of bile or to produce (any) organic acids is also not clearly testable since the level of growth and the amount of bile present is not specified, and it is not clear which organic acid to test for given that thousands of different organic acids exist.
Claim 3 recited “competence of the microorganism is reduced” however, no exact test is provided to determine levels of reduction. Claim also recited “preferably not able to take up DNA by natural transformation”, however, the size and sequence of the test DNA is not specified, neither are the exact medium, growth phase etc. etc. Thus, the presence and levels of induction factors (e.g. reduction of certain nutrient levels) will have a huge impact on levels of foreign DNA uptake. Therefore, the scope of claim 3 being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 4 has recited "competence genes" which is not known in the vast majority of organisms, neither is it definitively established in the more frequently studied ones (see below Ogura et al. (Journal of Bacteriology, May 2002, p. 2344–2351; cited in PTO892). Thus, the scope of deletion mutants covered is entirely unclear. Thus, having a "competence gene" which has reduced activity (note: reduced is also unclear without standard) or is knocked out is also viewed as an unusual parameter for the definition of microorganisms, which could serve to indefinite for failing to particularly point out.
Claim 5 has recited “competence gene is comK”- however, the standard sequence of comK is not defined, it is not possible to say how many mutations a given sequence has. Further, "reduced activity" is again unclear as lacking reference.
Claim 14 provide for the use of microorganisms, however, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q).
Appropriate correction is required.
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 1-7 and 11-15 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.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation.
Regarding claim 1: Claim 1 is directed at microorganisms wherein microorganisms have reduced competence. The instant specification teaches that the microorganisms are preferably naturally occurring microorganisms or spontaneous mutants of such naturally occurring microorganisms or microorganisms which are obtained by another method which is classified as non-GMO (See SPEC Col 2 lns 29-31). Spec Further disclose that the microorganisms according to the invention may be any kind of microorganisms which normally possess natural competence, in particular endospore-forming bacteria and/or nonsporulating bacteria, but in a preferred embodiment of the invention, the microorganisms are endospore-forming bacteria (See SPEC Col 4 lns 35-38). Therefore, the broadest reasonable interpretation of the instant claim is microorganisms. The analysis is as follows:
Step 1: The claim is directed to microorganisms, which is a composition and a statutory category of matter (Step 1: YES).
Step 2A, prong 1: The claim reads on microorganisms. The closest naturally occurring counterpart would be PGT cells generated without artificial manipulation or intervention. There is no indication or evidence in the specification that the claimed cell differs physically, structurally, or functionally from naturally occurring microorganisms. Thus, the claimed cell does not have markedly different characteristics from what occurs in nature and is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A, prong 1: YES).
Step 2A, prong 2: The claim is directed to a product and does not recite any structure that serves to integrate the composition into a practical application (Step 2A, prong 2: NO).
Step 2B: There are no additional elements required by the claim.
Therefore, claim 1 does not qualify as eligible subject matter and is rejected under 35 U.S.C. 101 and dependent claims 2-7 and 11-15.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). See MPEP 2173.05(q).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Anticipated by Sinderen et al.
Claims 1-6 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sinderen et al. (Molecular Microbiology (1994) 11(4), 695-703; cited in IDS filed 08/15/2024; hereinafter “Sinderen”).
Regarding claims 1, 3-6, Sinderen discloses B. subtilis with an insertion in its transcription factor comK gene (abstract). Deletion of comK caused a complete block in competence development which emphasizes the absolute necessity of the comK gene product in this process (p. 700 left hand col. 2nd ¶) and showing that the competence was reestablished using a plasmid-based comK gene, thus proving functionality thereof as a regulator of competence (summary and table 1).
Regarding claim 2 Sinderen discloses the product of microorganism with reduced competence substantially identical in composition to the presently claimed product. The scope of probiotic activity of microorganisms as recited in claim 2 merely states the characteristics (probiotic activity) of the claimed microorganism with reduced competence have the same structure as microorganism with reduced competence of Sinderen et al. and therefore would necessarily have the same characteristics. MPEP 2112.01(II) recites that if the composition is physically the same, it must have the same properties: "Products of identical chemical composition cannot have mutually exclusive properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The structure of the microorganism with reduced competence and its properties are inseparable. Therefore, if the prior art teaches the identical product and the activity applicant claimed are necessarily present in microorganism with reduced competence.
Accordingly, Sinderen anticipates the instant claims 1-6.
Anticipated by Ogura et al.
Claims 1-6 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ogura et al. (Journal of Bacteriology, May 2002, p. 2344–2351; cited in PTO892; hereinafter “Ogura”).
Regarding claims 1, 3-6, Ogura discloses the Bacillus subtilis (e.g., microorganism) competence transcription factor ComK is required for establishment of competence for genetic transformation. In an attempt to study the ComK factor further, Ogura confirmed the ComK dependence of 16 genes by using lacZ fusions, and three genes were partially dependent on ComK. Transformation efficiency was significantly reduced in ComK-dependent genes smf disruption mutant (abstract, p. 2350 left hand side 3rd ¶). In fact, disruption of smf resulted in a decrease in transformation efficiency (FIG. 1).
Regarding claim 2, Ogura discloses the product of microorganism with reduced competence substantially identical in composition to the presently claimed product. The scope of probiotic activity of microorganisms as recited in claim 2 merely states the characteristics (probiotic activity) of the claimed microorganism with reduced competence have the same structure as microorganism with reduced competence of Ogura et al. and therefore would necessarily have the same characteristics. MPEP 2112.01(II) recites that if the composition is physically the same, it must have the same properties: "Products of identical chemical composition cannot have mutually exclusive properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The structure of the microorganism with reduced competence and its properties are inseparable. Therefore, if the prior art teaches the identical product and the activity applicant claimed are necessarily present in microorganism with reduced competence.
Accordingly, Ogura anticipates the instant claims 1-6.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 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 the 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., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-6, 7 and 11-15 Claims are rejected under 35 U.S.C. 103 as being unpatentable over Sinderen et al. (Molecular Microbiology (1994) 11(4), 695-703; cited in IDS filed 08/15/2024), in view of Azimonti et al., (EFSA J. 2021 Jun 16;19(6):e06620; cited in PTO892; hereinafter “Azimonti”).
As discussed previously, Sinderen discloses B. subtilis with an insertion in its transcription factor comK gene (abstract). Deletion of comK caused a complete block in competence development which emphasizes the absolute necessity of the comK gene product in this process (p. 700 left hand col. 2nd ¶) and showing that the competence was reestablished using a plasmid-based comK gene, thus proving functionality thereof as a regulator of competence (summary and table 1).
Still regarding 7, Sinderen is silent to the strain is a B. velezensis strain, however, such was known in the prior art.
Regarding claims 7 and 11-15, Azimonti teaches Bacillus velezensis strain CECT 5940 is a beneficial spore-forming bacterium used globally as a zootechnical feed additive to stabilize gut flora in poultry. Therefore, Azimonti teaches food additive containing B. velezensis strain identical to the genomic DNA of the strain CECT 5940 (abstract, p. 4 see “Additional information” ¶ of Azimonti). Azimonti further discloses the additive consists of spores of B. velezensis CECT 5940, in feed for chickens for fattening and chickens reared for laying (e.g., method of feeding animals), therefore, it would be obvious POSITA could recognize the additive contains pharmaceutically acceptable carrier (p. 5 see “Characterisation of the additive” ¶ of Azimonti).
Accordingly, it would have been obvious to practice the microorganism with reduced competence of Sinderen and include Bacillus velezensis strain CECT 5940 as taught by Azimonti with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so as taught by Azimonti because it has the potential to be efficacious in turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for breeding, and ornamental birds (except for reproduction) at 1 9 109 CFU/kg complete feed (p. 7 1st ¶ of Azimonti). The POSITA would have had a reasonable expectation of success in combining the teachings of Sinderen and Azimonti because each of these teachings both successfully generated the microorganism. Therefore, the products as taught by Sinderen et al. in view of Azimonti et al. would have been prima facie obvious over the products of the instant application. In regard to the reasonable expectation of success in doing so, including the Bacillus velezensis strain CECT 5940 of Azimonti had a reasonable expectation of success since the steps thereof required no more than pipetting the appropriate concentration and cell culture technology.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/MASUDUR RAHMAN/Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
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