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 .
Applicant’s response filed 11/6/2026 has been received and entered into the case. All arguments and amendments have been considered.
Claims 27, 28, 31-83 are pending.
Claims 35-75 are withdrawn.
Claims 27, 28, 31-34, 76-83 have been considered on the merits herein.
The following rejections have been withdrawn in light of applicants claim amendments; Claim(s) 27, 28, 29, 33, 34 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaneuchi et al. (Appl. and Env. Microb., 1988, IDS), Claim(s) 27, 28, 33, 34 rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by JPS60105489 (IDS), and Claim(s) 27- 34 rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by JP6209371B2 (IDS).
Claim Rejections - 35 USC § 112
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 77, 78, 82 and 83 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.
Claim 77, 78, 82 and 83 recites the limitation "the culture medium or raw material milk" in claims 27 and 33. There is insufficient antecedent basis for this limitation in the claim. Claim 27 does not recite a culture medium or raw material milk. While claim 33 recites a medium, it does not recite a “culture medium or raw material milk”.
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.
Claim(s) 27, 28, 33, 34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP2016214241 (IDS).
Regarding claims 27, 28, 33, 34, JP241 teaches performing lactic acid fermentation in the presence of organic acids selected from fumaric acid and malic acid. (p. 2, whole pg., p. 3, 3rd and 4th parag.). The reference teaches that the organic acid is added in amounts ranging from 0.001-0.07% by weight based on the total fermentation milk raw material (p. 3, 3rd-5th parag.).
Regarding claim 27, the lactic acid bacteria is L. delbrueckii subsp. bulgaricus (p. 8, 2nd parag., Ex. 2, p. 12, Ex. 3).
The claimed method requires a single step of performing lactic acid fermentation in the presence of at least one organic acid selected from malic acid and fumaric acid.
A "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. The only method step is performing lactic acid fermentation in the presence of malic or fumaric acid, and thus the “wherein EPS is produced by the method” and “wherein a succinic acid is produced” of claim 28 is an intended result of the fermentation step, 1614, 1620 (Fed. Cir. 2003)) as well as a function of the fermentation with the organic acid. The method of JP241 is drawn to the same method as claimed, i.e. fermentation of L. delbrueckii subsp bulgaricus with an organic acid. Thus, it is the Examiners position that these results are inherent to the fermentation step taught by JP241. One would necessarily expect to achieve the same results when practicing the method of JP241, which is the same as applicants claimed method.
Thus, the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
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 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, 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.
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.
Claim(s) 27, 28, 31-34, 76-83 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP6209371B2 (IDS) in view of JPS60105489 (IDS), Jung et al. (1994, IDS), JP2016214241 (IDS).
The claimed method requires a single step of performing lactic acid fermentation in the presence of at least one organic acid selected from malic acid and fumaric acid.
Regarding claims 27, 28, 33, 34, JP371 teaches a method for producing an extracellular polysaccharide (EPS) comprising performing lactic acid fermentation with an EPS producing strain, L. delbrueckii subsp. bulgaricus, specifically strain OLL1073R-1. JP371 teaches that malic acid may be added to the lactic acid EPS producing culture medium (p. 9, last 2 parag.-p. 10, 1st parag.).
Regarding claims 31, 32, 80, 81, JP371 teaches that L. delbrueckii subsp. bulgaricus , specifically strain OLL1073R-1, is a lactic acid bacteria used in fermented milk production which produces EPS (p. 2, 2nd parag.).
Regarding claim 76, 79, the reference is drawn to only using L. delbrueckii subsp. bulgaricus, OLL1073R-1, in the fermentation method to produce EPS.
The reference teaches that improving the number/increasing growth of the lactic acid bacteria in the fermentation also increases EPS production.
While the reference exemplifies formate used in the fermentation medium in amounts ranging from 0.4 to 10 mM (p. 3, last parag., p. 5, 1st parag.) to increase lactic acid bacteria growth and therefore EPS production, the reference suggests that organic acids including malic acid may be added to the EPS production medium (p. 6 2nd to last parag., p. 7, 1st parag.). Thus, regarding claims 78 and 83, JP371 teaches adding amounts of a growth promoter within applicants claimed range, and thus, a posita has good reason to pursue known options within his or her technical grasp when adding growth promoters to the medium. See below for teachings related to malic and fumaric acid.
JP489 teaches a method comprising performing lactic acid fermentation in the presence of malic acid, wherein the presence of malic acid increases growth of the lactic acid bacteria in the starter medium (p. 1, 5th and 6th parag., p.3, last 3 parag.-p. 4, 1st parag., 2nd parag., p. 5, 6th parag.).
Regarding claims 77, 82, JP489 teaches adding malic acid in amounts ranging from 0.05 to 0.5M, i.e. 50 mM, to the culture medium (p. 3, 3rd parag.).
Jung teaches that the addition of 1% wt. fumaric acid to fermentation medium of L. delbrueckii subsp. bulgaricus increases bacterial growth and malic acid is produced from the fumaric acid addition (p. 470, test sample section, Table 1, p. 471, 1st and 2nd parag., p. 474, Summary section).
JP241 teaches performing lactic acid fermentation in the presence of organic acids selected from fumaric acid and malic acid. (p. 2, whole pg., p. 3, 3rd and 4th parag.). The reference teaches that the organic acid is added in amounts ranging from 0.001-0.07% by weight based on the total fermentation milk raw material (p. 3, 3rd-5th parag.).
Regarding claim 27, the lactic acid bacteria is L. delbrueckii subsp. bulgaricus (p. 8, 2nd parag., Ex. 2, p. 12, Ex. 3).
Therefore, before the effective filing date of the claimed invention, it was known in the art that the lactic acid bacterium L. delbrueckii subsp. bulgaricus produces EPS during fermentation. Additionally, organic acids added to the fermentation medium including malic and fumaric acid were known to increase the growth rate of lactic acid bacterium and thus, increasing EPS production. While JP371 teaches using formate to increase lactic acid growth, organic acids malic and fumaric acids were disclosed by the prior art references to successfully increase L. delbrueckii subsp. bulgaricus growth during the fermentation process. Thus, a posita would have had a reasonable expectation of successfully substituting the formate of JP371 with malic or fumaric acid (of JP489, Jung, and JP421) in a fermentation method and medium for producing EPS because the art collectively teaches that not only is the claimed strain an EPS producing strain, but adding growth promoters to the fermentation medium increases the lactic acid bacteria growth thereby increasing EPS production. Therefore, the results of the substitution would have been predictable at the time of the claimed invention and one would have had a reasonable expectation of successfully producing EPS in culture with the claimed strains and organic acids as growth promoters.
A "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. The only method step is performing lactic acid fermentation in the presence of malic or fumaric acid, and thus the “wherein EPS is produced by the method” and “wherein a succinic acid is produced” of claim 28 is an intended result of the fermentation step, 1614, 1620 (Fed. Cir. 2003)) as well as a function of the fermentation with the organic acid. The method of the prior art are drawn to the same method as claimed, i.e. fermentation of L. bulgaricus with an organic acid. Thus, it is the Examiners position that these results are inherent to the fermentation step taught by the art. One would necessarily expect to achieve the same results when practicing the prior art method of performing lactic acid bacterial fermentation is the presence of an organic acid selected from malic or fumaric acid to a fermentation, which is the same as applicants claimed method.
Response to Arguments
Applicant's arguments filed 11/6/2025 have been fully considered but they are not persuasive. Regarding the JP241 reference, applicants argue that the reference is silent regarding the limitation that EPS is produced by the method.
As seen above in the maintained 102 rejection over JP241, the claimed method requires a single step of performing lactic acid fermentation in the presence of at least one organic acid selected from malic acid and fumaric acid.
A "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d. The only method step is performing lactic acid fermentation in the presence of malic or fumaric acid, and thus the “wherein EPS is produced by the method” and “wherein a succinic acid is produced” of claim 28 is an intended result of the fermentation step, 1614, 1620 (Fed. Cir. 2003)) as well as a function of the fermentation with the organic acid. The method of JP241 is drawn to the same method as claimed, i.e. fermentation of L. delbrueckii subsp bulgaricus with an organic acid. Thus, it is the Examiners position that these results are inherent to the fermentation step taught by JP241. One would necessarily expect to achieve the same results when practicing the method of JP241, which is the same as applicants claimed method.
MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-08.2012]
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 and 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.5.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
lll. A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR
ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS
SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C.103 and for anticipation under 35. U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103 rejection is appropriate for these types of claims as well as for composition claims.
Applicants’ arguments directed to performing the fermentation with only L. bulgaricus has been considered; however new claims drawn to this limitation are addressed in the new 103 rejection herein. JP241 is not applied over those claims.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIFFANY M GOUGH/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651