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 3/30/26. Claims 1-40 are pending. Claims 1-27 were withdrawn. Claims 28-40 have been examined on the merits.
Withdrawn Rejections
The claim objection to claims 35 and 36 have been withdrawn due to the amendments to the claims.
The 112(a) rejection of claim 31 has been withdrawn due to the declaration filed.
The 102(a)(1) rejections of claims 28, 29, 33, 34, 36, 37, 38, 39, and 40 by Mygind et al. (US 20150045288) have been withdrawn due to the amendment to claim 28.
The 102(a)(1) rejection of claim 32 by Mygind et al. (US 2015/0045288) as evidenced by Food Info.net “What is the pH of Foods?” 2021 has been withdrawn due to the amendment to claim 28.
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 28-31, and 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over Mygind et al. (US 20150045288) in view of GUILHABERT-GOYA et al. (WO 2014085576.
Regarding Claims 28-30: Mygind discloses a composition containing a fermentation product/fermentate/anti-contamination product of Bacillus subtilis [abstract; 0086; 0090]. Mygind discloses a food product containing the fermentation product of Bacillus subtills to prevent contamination within the food product [0002; 0107; 0433; claim 118]. Mygind discloses a substrate for the fermentation [0094]. Mygind also discloses that some strains of B. subtilis used in the invention may be reclassified as B. amyloliquefaciens [0181].
However, Mygind does not definitively disclose B. amyloliquefaciens.
Guilhabert-Goya discloses B. subtilis and B. amyloliquefaciens as having high inhibitory activity concerning bacteria and fungi [abstract; 0009;]. Guilhabert-Goya discloses using the fermentation products of B. subtilis and B. amyloliquefaciens for improving the quality of foods, prolonging shelf life and improving food safety [0018; 0021; 0023]. Guilhabert-Goya discloses providing the fermentation product/fermentate in liquid or powdered forms [0082; 0086]. Guilhabert-Goya discloses providing the fermentation product/fermentate in foods [0081].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the food product of Mygind to include the B. amyloliquefaciens of Guilhabert-Goya with or to substitute the B. amyloliquefaciens of Guilhabert-Goya for the B. subtilis in Mygind since they are both disclosed in Guilhabert-Goya as having a beneficial effect in protecting foods which is also the aim of Mygind, since Mygind discloses that some B. subtilis strains may in fact be reclassified B. amyloliquefaciens and since the selection of B. amyloliquefaciens would have been within the abilities and desire of one of ordinary skill in the art based on availability, cost, or personal preference.
Regarding Claim 31: Mygind discloses as discussed above in claim 30. Mygind discloses B. subtilis also discloses that some strains of B. subtilis used in the invention may be reclassified as B. amyloliquefaciens [0181].
However, Mygind does not definitively disclose B. amyloliquefaciens strain 723.
Guilhabert-Goya discloses B. subtilis and B. amyloliquefaciens as having high inhibitory activity concerning bacteria and fungi [abstract; 0009;]. Guilhabert-Goya discloses using the fermentation products of B. subtilis and B. amyloliquefaciens for improving the quality of foods, prolonging shelf life and improving food safety [0018; 0021; 0023]. Guilhabert-Goya discloses proving the product in liquid or powdered forms [0082; 0086]. Guilhabert-Goya discloses providing the product in foods [0081].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the food product of Mygind to include the B. amyloliquefaciens of Guilhabert-Goya with or to substitute the B. amyloliquefaciens of Guilhabert-Goya for the B. subtilis in Mygind since they are both disclosed in Guilhabert-Goya as having a beneficial effect in protecting foods which is also the aim of Mygind, since Mygind discloses that some B. subtilis strains may in fact be reclassified B. amyloliquefaciens and since the selection of B. amyloliquefaciens would have been within the abilities and desire of one of ordinary skill in the art based on availability, cost, or personal preference.
The prior art reference above discloses the use of B. amyloliquefaciens for the purpose of inhibiting pathogenic microorganisms by adding B. amyloliquefaciens to food. The B. amyloliquefaciens appears to be identical to the presently claimed strain and is considered to anticipate the claimed microorganism since B. amyloliquefaciens s taught to inhibit the growth of the same claimed food-borne pathogenic microorganisms. Alternatively, even if the claimed microorganisms are not identical to the prior art strains, the difference between the strains is considered to be so slight that the prior art microorganisms are likely to inherently possess the same characteristics of the claimed microorganisms particularly in view of the similar characteristics which they have been disclosed to share. The claimed strain would have been obvious to one of ordinary skill in the art, and therefore the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
Further, despite Applicants’ recitation of B. amyloliquefaciens strain 723 for the isolated strains claimed, this does not provide a patentable distinction over those strains disclosed by Guilhabert-Goya as also having protective ability, absent any clear and convincing evidence otherwise. 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 shifts 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 Guilhabert-Goya; 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 food preserving properties and utilize such strains within the known methods of Guilhabert-Goya.
Although Guilhabert-Goya does not disclose the specific strain as presently claimed, it would have been obvious to one of ordinary skill in the art to use B. amyloliquefaciens strains capable of providing some sort of protective effect in food. Absent any evidence to contrary and based on the teachings of the cited reference, there would have been a reasonable expectation of success in using B. amyloliquefaciens for protective effect in food.
Regarding Claim 33: Mygind as modified discloses as discussed above in claim 28. Mygind discloses that the food products can be culinary items [0441], bakery items [0433], meats [0433; 0472], dairy items [0433], fish [0470], beverages (fermented milk) [0433], confections [0433], pet food [0351], fruits [0433], and vegetables [0434].
Regarding Claim 34: Mygind as modified discloses as discussed above in claim 28. Mygind discloses including the fermentate/anti-contamination composition at about 0.1% to about 5% [0517].
Regarding Claim 35: Mygind as modified discloses as discussed above in claim 28. Mygind discloses that the anti-contaminant agent/fermentate may contain additional ingredients such as food grade organic acids [0398]. However, the fermentate of Mygind does not disclose that an organic acid is produced as part of the fermentation product such that the organic acid is at a level that inhibits the growth of microorganisms and therefore renders the claim obvious. Further since Mygind suggests the inclusion of an organic acid this also renders obvious the fact that a sufficient amount or organic acid is not produced by the B. amyloliquefaciens.
Regarding Claim 36: Mygind discloses as discussed above in claim 28. Mygind discloses that the composition has antifungal and antibacterial properties [abstract; 0062; 0063; claim 114].
Regarding Claim 37: Mygind as modified discloses as discussed above in claim 28. Mygind discloses that the substrate can be non-fat dry milk, vegetables, starch, grains, fruit, sugar, cultured dextrose [0094].
Regarding Claim 38: Mygind as modified discloses as discussed above in claim 28. Mygind discloses that the fermentate/anti-contamination fermentation product is in liquid form and where it is concentrated via centrifugation of the media [0080; 0262; 0546; 0620].
Regarding Claim 39: Mygind as modified discloses as discussed above in claim 28. Mygind discloses that the fermentate/anti-contamination fermentation product is a dry powder form [0080; 0546; 0548].
Regarding Claim 40: Mygind as modified discloses as discussed above in claim 28. Mygind discloses a significant reduction in Salmonella when the Bacillus subtilis fermentate was applied at 1% [0303; 0658] which anticipates the claim limitation wherein the fermentate has the ability to inhibit
the growth of a contaminating microorganism up to 100% when diluted to less than 5% (w/v).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Mygind et al. (US 2015/0045288) in view of Guilhabert-Goya et al. (WO 2014085576) as applied to claim 28 above and as evidenced by Food Info.net “What is the pH of Foods?” 2021.
Regarding Claim 32: Mygind discloses as discussed above in claim 28. Mygind also discloses that the food products can be eggs, cream, butter, canned foods, bakery items like cake [0433, 0438], meats [0433; 0472], chicken [0473; 0485]; turkey [0473; 0485]; beef [0485]; dairy items [0433], fish [0470], beverages (fermented milk) [0433], confections [0433], pet food [0351], and vegetables [0434]. Mygind does not explicitly disclose the pH of the food items. However, Food Info teaches that the pH of these food products, including meats and eggs, exceed a pH of 5.5 [pg. 4; pg. 5] and therefore at least the meat and eggs of Mygind would have met the claim limitation as the pH levels are inherent in the foods. Mygind also discloses the strains at a pH of 5 to 9 or 6 to 10 [0087; 0088].
Response to Arguments
The claim objection to claims 35 and 36 have been withdrawn due to the amendments to the claims.
The 112(a) rejection of claim 31 has been withdrawn due to the declaration filed.
The 102(a)(1) rejections of claims 28, 29, 33, 34, 36, 37, 38, 39, and 40 by Mygind et al. (US 20150045288) have been withdrawn due to the amendment to claim 28.
The 102(a)(1) rejection of claim 32 by Mygind et al. (US 2015/0045288) as evidenced by Food Info.net “What is the pH of Foods?” 2021 has been withdrawn due to the amendment to claim 28.
Regarding the 103 rejections under Mygind in view of Guilhabert-Goya, the Applicants assert that Guilhabert-Goya discloses a vast genus of Bacillus strains and that it does not disclose them for direct use in food. The Applicants also assert that the claimed strain is able to achieve 100% inhibition.
The Examiner disagrees that a vast genus is disclosed in Guilhabert-Goya. The Examiner notes that Guilhabert-Goya discloses B. subtilis and B. amyloliquefaciens and specifically claims them in claim 14. The Examiner notes that Applicants arguments are not commensurate with the scope of the claims because the claims do not require 100% inhibition.
Regarding the rejection of claim 35, the Applicants assert that the teachings of Guilhabert-Goya constitute a teaching away of the instant invention because the food systems of the instant invention are not compatible with acidification because it is either undesirable or ineffective.
The Examiner disagrees because Mygind discloses Bacillus sp. in food and at the claimed pH levels. Further Guilhabert-Goya does disclose using B. amyloliquefaciens as a species for controlling fungi in food or feed and therefore discloses food systems and specifically discloses dairy product, breads, meats, processed foods and packaged foods and fruits and vegetables [0018; 0021; 0023;0031; 0081].
A prior art reference that "teaches away" from the claimed invention is a significant factor to be considered in determining obviousness; however, "the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, "the prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Conclusion
16. 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.
17. 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
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