/5/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 .
This office action was written in response to the Applicants Remarks filed 12/5/25. Claims 1-3, 5, 7-18 are pending. Claims 11-17 have been withdrawn. Claims 1-3, 5, 7-10, and 18 are pending and have been examined on the merits.
Withdrawn Rejections
Claims 1, 2, 3, 7, 8, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hou 2005 Applied Microbial and Cell Physiology vol. 69 pages 463-468 in view of Kendirgi et al. (WO 2018/045004) sequence found in equivalent (US 2019/0183131) and in further view of Hou (“Hou 2”) New Biotechnology Vol. 26 Numbers ½ October 2009 pages 2-10 and B.R.A.I.N (EP 2426198).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 3, 7, 8, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hou 2005 Applied Microbial and Cell Physiology vol. 69 pages 463-468 in view of Kendirgi et al. (WO 2018/045004) sequence found in equivalent (US 2019/0183131) and in further view of Hou (“Hou 2”) New Biotechnology Vol. 26 Numbers ½ October 2009 pages 2-10 and B.R.A.I.N (EP 2426198).
Regarding Claim 1: Hou discloses the production of oxygenated unsaturated fatty acids from linoleic acids by Bacillus megaterium ALA2 [abstract]. Hou discloses cultivating the bacteria in the presence of linoleic acid (omega 6 fatty acid) and KHPO4, MgSO4, MnSO4, ZnSO4, which are salts [pg. 464, 2nd column]. It is obvious that the production of unsaturated fatty acids would be associated with salts since the medium contains salts.
Hou does not explicitly disclose that the Bacillus megaterium selected from the group consisting of Bacillus megaterium DSM 32963, Bacillus megaterium DSM 33296, and Bacillus megaterium DSM 33299.
Hou does not disclose EPA, ARA or DHA.
Hou does not disclose a probiotic strain of a genus Bacillus megaterium encoding an enzyme that comprises both a P450 oxygenase and a NADPH:P-450 reductase.
Kendirgi discloses a Bacillus megaterium Seq 3 having 99.7% sequence identity with Bacillus megaterium DSM 32963 Seq 1 [pg.3].
“Hou 2” discloses a composition containing B. megaterium and a fatty acid [abstract]. “Hou 2” discloses that the fatty acid can be EPA, DHA, linoleic acid, ARA, α and γ-linolenic acid [pg. 6-8]. “Hou 2” discloses that EPA, DHA, α-linolenic acid are omega 3 fatty acids and linoleic, γ-linolenic acid and ARA are omega-6 fatty acids [pg. 7 1st col., pg. 8 2nd col.].
B.R.A.I.N discloses Bacillus megaterium as encoding P 450 oxygenase and NADPH: P-450 reductase [0004, 0005; claim 1].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Hou to substitute the B. megaterium of Hou for the B. megaterium of Kendirgi to ferment a substrate and to obtain expected results such as a preparation comprising B. megaterium and a polyunsaturated fatty acid.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Hou to include EPA, DHA, ARA, and α and γ-linolenic acid as in “Hou 2” since “Hou 2” discloses the B. megaterium of Hou and that it is able to convert EPA, DHA, ARA, and α and γ-linolenic in addition to linoleic acid.
Further it would have been obvious to one of ordinary skill in the art that the B. megaterium of modified Hou would have encoded P 450 oxygenase and NADPH: P-450 reductase as in B.R.A.I.N since it discloses this as a feature of B. megaterium.
Despite Applicants’ recitation of B. megaterium DSM 32963, Bacillus megaterium DSM 33296, and Bacillus megaterium DSM 3329 for the isolated strains claimed, this does not provide a patentable distinction over those strains disclosed by Kendirgi as also having fatty acid converting ability. The USPTO does not possess the facilities to test each strain of microorganism. However, it is reasonable to conclude that there is no patentable distinction and thus the burden shift to the Applicants to demonstrate that the strain of the reference is not in fact the same or an obvious variant of the claimed strain.
Alternatively, given the specific teachings of modified Hou; one would have been motivated to routinely screen out the identified strains, using conventional methods known in the art and expecting to isolate strains with fat converting properties and utilize such strains within the known methods of Hou.
Further as discussed above Kendirgi discloses B. megaterium having a 99.7% sequence identity to Seq 1 and is therefore substantially close to that of the instant claims, one of ordinary skill would have expected compositions that are in such close proportions to those in prior art to be prima facie obvious and to have same properties. Titanium Metals Corp., 227 USPQ 773 (CAFC 1985).
Regarding Claim 2: Hou discloses as discussed above in claim 1. Hou discloses that the cells are vegetative since they are able to grow [abstract].
Regarding Claim 3: Hou as modified discloses as discussed above in claim 1. Hou discloses that the omega-6 fatty acids are derived from vegetable oils and therefore natural triglycerides [abstract].
Regarding Claim 7: Hou discloses as discussed above in claim 1. Hou does not disclose an omega 3 fatty acid.
“Hou 2” discloses a composition containing B. megaterium and a fatty acid [abstract]. “Hou 2” discloses that the fatty acid can be EPA, DHA, linoleic acid, ARA, α and γ-linolenic acid [pg. 6-8]. “Hou 2” discloses that EPA, DHA, α-linolenic acid are omega 3 fatty acids and linoleic, γ-linolenic acid and ARA are omega-6 fatty acids [pg. 7 1st col., pg. 8 2nd col.].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Hou to include EPA, DHA, ARA, and α and γ-linolenic acid as in “Hou 2” since “Hou 2” discloses the B. megaterium of Hou and that it is able to convert EPA, DHA, ARA, and α-linolenic in addition to linoleic acid. Further it would have been obvious that the medium would have contained omega 3 fatty acid salt since the medium was fermented in the presence of omega-3 fatty acids and since the medium contains salts and therefore the fatty acids would have been associated with the salts.
Regarding Claim 8: Hou as modified discloses as discussed above in claim 1. Hou does not explicitly disclose the presence of a phospholipid. However, it is well known in the art that cell membranes contain phospholipid. Therefore by the presence of the bacteria, Bacillus megaterium, in medium with the fatty acid, a phospholipid would have been therefore present along with the omega-6 fatty acid due to the B. megaterium cell membrane.
Regarding Claim 18: Hou as modified discloses as discussed above in claim 1. Hou does not disclose that when orally administered, claim 1 increases the formation of specialized pro-resolving lipid mediators (SPMs).
“Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Further, claim 18 is a recitation of the intended use of the claimed invention and in order to patentably distinguish the claimed invention from the prior art, the recitation must result in a structural difference between the claimed invention and the prior art. MPEP 2103 states that intended use language "does not limit a claim to a particular structure does not limit the scope of a claim". The above mentioned phrase does not limit the claim to any particular structure, so it is not interpreted to limit the scope of the claims. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hou 2005 Applied Microbial and Cell Physiology vol. 69 pages 463-468, Kendirgi et al. (WO 2018/045004) sequence found in equivalent (US 2019/0183131) and Hou (“Hou 2”) New Biotechnology Vol. 26 Numbers ½ October 2009 pages 2-10 as applied to claim 1 above and in further view of Martin et al. CA 2457662.
Regarding Claim 5: Hou discloses as discussed above in claim 1. Hou did not disclose 5-Aminolevulinic Acid.
Martin discloses fermented in B. megaterium in the presence of 5-Aminolevulinic acid for the production of vitamin B12 [pg. 1, 1st and 2nd paragraph; claim 1].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Hou to include 5-Aminolevulinic acid as in Martin in order to produce the beneficial vitamin, B-12.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hou 2005 Applied Microbial and Cell Physiology vol. 69 pages 463-468, Kendirgi et al. (WO 2018/045004) sequence found in equivalent (US 2019/0183131), and Hou (“Hou 2”) New Biotechnology Vol. 26 Numbers ½ October 2009 pages 2-10 as applied to claim 1 above and in further view of JP 2005507670 March 2005.
Regarding Claim 9: Hou discloses as discussed above in claim 1. Hou does not disclose further comprising a coating for delayed release, or enteric, or colonic release
JP’670 discloses vegetative B. megaterium cells [Ex. 1]. JP’670 discloses coupling B. megaterium in an enteric coating for delivery to a subject [Ex. 2]. JP’670 discloses enteric coating to prevent dissolution in the stomach and for dissolution in the intestines [0026; 0027].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Hou to include enteric coating as in JP’670 in order to protect the B. megaterium as it travels through the stomach and to allow for dissolution in the intestines so that it may colonize the intestines.
Regarding Claim 10: Hou discloses the production of oxygenated unsaturated fatty acids from linoleic acids by Bacillus megaterium ALA2 [abstract]. Hou discloses cultivating the bacteria in the presence of linoleic acid (omega 6 fatty acid) and KHPO4, MgSO4, MnSO4, ZnSO4, which are salts [pg. 464, 2nd column]. It is obvious that the production of unsaturated fatty acids would be associated with salts since the medium contains salts.
Hou does not disclose a food or feed composition.
JP’670 discloses a feed containing Bacillus megaterium [0016].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to include the composition of Hou in a food or feed in order to make the beneficial B. megaterium accessible through food or feed to animals as disclosed in JP’670.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hou 2005 Applied Microbial and Cell Physiology vol. 69 pages 463-468, Kendirgi et al. (WO 2018/045004) sequence found in equivalent (US 2019/0183131), and Hou (“Hou 2”) New Biotechnology Vol. 26 Numbers ½ October 2009 pages 2-10 as applied to claim 1 above and in further view of Spite et al. Cell Metabolism Review Vol. 19 January 7 2014 pages 21-36.
Regarding Claim 18: Hou as modified discloses as discussed above in claim 1. Hou does not disclose that when orally administered, claim 1 increases the formation of specialized pro-resolving lipid mediators (SPMs).
Spite discloses specialized proresolving lipid mediators (SPMs) are produced from EPA and DHA [abstract; pg. 22 Fig, 1; pg. 23. 1st column, 1st and 2nd full paragraphs].
At the effective filing date of the invention it would have been obvious to one of ordinary skill that the preparation of modified Hou would have produced SPM since Spite discloses the presence of EPA and DHA which are disclosed in modified Hou produces SPM.
“Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Response to Arguments
8. Applicant's arguments filed 12/5/25 have been fully considered but they are not persuasive. The Applicants assert that the Office has not shown that the CYP450 gene in the prior art is the same as in the recited strains of B. megaterium. The Applicants assert that there is a high degree of diversity among CYP450 genes. The Applicants assert that the nature of the CYP 450 genes determines the functionality of each strain with respect to the formation of SPM from omega 3 fatty acids.
The Examiner notes that Applicants assert that the CYP450 gene sequences are novel. However, it is not the gene sequence that is claimed, the probiotic strain of B. megaterium need only encode P450 oxygenase and NAPHD:P-450 reductase. BRAIN discloses B. megaterium as producing P450 oxygenase and NAPHD:P-450 reductase. The disclosure in BRAIN is sufficient to meet the claim limitation. The features recited in the claim are features which are found amongst the members of B. megaterium. There is nothing novel in using B. megaterium as presently claimed. Applicants have not shown that the claimed strains of B. megaterium provide a new advantage or non-obvious function of the over other strains of B. megaterium or the strain of Kendirgi which has a 99.7% sequence identity to Bacillus megaterium DSM 32963. The claims are not directed to only a claimed strain but a preparation. There is nothing new in using the microorganism in a preparation.
Pertinent Prior Art
9. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hilker et al. “Some properties of a Self-Sufficient Cytochrome P-450…” Chapter 16 2008 Biocatalysts and Bioenergy.
Conclusion
10. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Felicia C Turner/Primary Examiner, Art Unit 1793