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 .
DETAILED ACTION
This Office Action is in response to Applicants’ Amendment and Remarks filed on 2/13/2026 in which claims 1-5, 7, 8 and 11-17 are cancelled, claims 6 is amended and claims 18-22 are newly added.
Claims 6, 9, 10 and 18-22 are pending in the instant application and are examined on the merits herein.
Priority
The application claims benefit to provisional application US 63/326567 filed on 4/1/2022.
Withdrawn Rejections
All rejection(s) of record for claim(s) 1-5, 7, 8 and 11-17 is/are hereby withdrawn due to the cancellation of said claim(s) rendering said rejection(s) moot.
Applicant’s amendment, filed on 2/13/2026, with respect to the rejection of claim 6 under 35 U.S.C. 102(a)(1) as being anticipated by Cong et al. (CN 103665175A, 2014 and claim 6 under 35 U.S.C. 102(a)(1) as being anticipated by Sang et al. (KR 20040017891, 2004), has been fully considered and is persuasive. The cited references do not disclose a levan with all the claimed properties. The rejections are hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) or modified rejections necessitated by Applicants' amendment, filed on 2/13/2026, wherein instant independent claims 6 is amended to alter the breadth and scope of the claim and claims 18-22 are newly added. Therefore, new grounds of rejection have been made or rejections from the previous Office Action have been modified.
Modified Rejections
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 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 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.
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.
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.
Claims 6, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Cong et al. (CN 103665175A, 2014, reference of record), in view of Tanaka et al. (J. Biochem., 1980, reference of record).
Cong discloses a method for treating obesity by administering an oral pharmaceutical composition comprising a levan with molecular weight of 2.5-8 kDa and an excipient. (Abstract, Claims)
Cong does not teach a levan having the claimed branching percentage or terminal fructose:glucose ratio.
Tanaka 1980 discloses levans having the following properties: (Figure 5)
Levan
Molecular weight (kDa)
% [2,1] glycosidic linkage branching
Fructose:glucose terminus ratio
a
7.53
2.22
3:1
b
15.8
3.41
7:1
c
23.8
3.03
11:1
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that one could substitute the levan of Cong with the levan Tanaka 1980, thereby arriving at the instant invention. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). The levans in Cong and Tanaka 1980 have similar molecular weights and there is nothing in Cong requiring the levan disclosed therein. Thus one of ordinary skill would expect the levan of either Cong or Tanaka 1980 to be functionally equivalent in a method of treating obesity.
It would have been further prima facie obvious that the terminal fructose:glucose ratios of Tanaka 1980 overlap those of the claims. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the rejection over Cong/Tanaka 1980, has been fully considered but is not persuasive.
Applicant argues that Tanaka 1980 does not disclose the information as asserted by the Office because Figure 5 of Tanaka 1980 does not contain the data as tabulated in the Office action. Applicants’ argument is not persuasive because while the tabulated data is not expressly disclosed by Tanaka 1980, it can be derived from the graphics in Figure 5, where each open circle represents a fructose, each filled circle represents a glucose, each open circle is connected by a 2-6 linkage and each arrow represent a 1-2 linkage. For instance, taking into consideration Figure 5a, there are 45 fructose and 1 glucose, with forty-four 2-6 linkages and a single 1-2 linkage. This yields a 1-2 linkage percentage of 1/45 x 100=2.22% and a 2-6 linkage percentage of 97.8%. In Figure 5a, there are 3 terminal fructose and one terminal glucose, giving a terminal unit ratio of fructose:glucose of 3:1. Moreover, given the molecular weight of glucosyl and fructosyl, at 163 Da and taking into account the terminal hydroxyl groups, the molecular weight of the levan in Figure 5a is 7.53 kDa. The values of the structures in Figure 5b and 5c, are computed similarly. The range of values derived from Tanaka 1980 overlaps that of the instant claims.
Applicant further argues that the specification presents evidence of unexpected results showing that the administration of levan with molecular weight and linkage pattern, as claimed, yields surprising anti-obesity treatment. Applicants argument is not persuasive because the anti-obesity data only compares treatment with low molecular weight levan to treatment without levan. There are no experiments comparing the effectiveness against obesity for administering levans across a range of molecular weights. The conclusion drawn from the data is that the presence of levan is critical but no conclusion can be made regarding a levan with a “low” molecular weight being more or less effective than a levan having any other molecular weight. The presence of levan in an anti-obesity treatment is taught by the prior art. Thus, the data presented in the specification are not unexpected.
The rejection is still deemed proper and is maintained.
Claims 6, 9, 10 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sang et al. (KR 20040017891, 2004, reference of record), in view of Mays (US 4,879,228; 1989, reference of record), in view of Tanaka et al. (J. Biochem, 1979, reference of record), in view of Tanaka et al. (J. Biochem., 1980, reference of record).
Sang discloses a method for treating obesity by administering a medicinal beverage composition comprising a levan. (Abstract; p. 12, 2nd¶; Embodiment 7) Sang references Mays et al. (US 4879228, 1989) for method of preparing levan. (p. 11, 2nd ¶) Sang also discloses that obesity is closely correlated with hypertension. (p. 2, 2nd¶)
Sang is silent on properties of levan including molecular weight, percentage branching, etc.
Mays discloses method of preparing levan where the molecular weight may be tailored based on controlling parameters and references Tanaka 1979 for guidance.
Tanaka 1979 discloses that levan may be enzymatically synthesized under conditions where the resulting levan may range from degree of polymerization 120-1200.
Tanaka 1980 discloses levans having the following properties: (Figure 5)
Levan
Molecular weight (kDa)
% [2,1] glycosidic linkage branching
Fructose:glucose terminus ratio
a
7.92
2.27
3:1
b
15.8
3.41
7:1
c
23.8
3.03
11:1
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that one would look to analogous art for guidance on levan properties suitable in a method of treating obesity with levan because Sang is silent on such properties, but Sang directs one to consider Mays. Within Mays one learns that levan molecular weight may be tailored based on synthesis conditions, where Mays directs one to consider Tanaka 1979. Tanaka 1979 teaches that the molecular weight of levan can vary across orders of magnitude, based on synthesis conditions. Thus it would have been obvious that the molecular weight of levan would be optimized in the method of Sang using routine experimentation based on guidance in Mays and Tanaka 1979. In considering Tanaka 1979, one would also reasonably look to Tanaka 1980 for additional guidance because Tanaka 1979 and Tanaka 1980 report work by the same authors regarding levan synthesis and characterization. Within Tanaka 1980 is guidance on levan having molecular weight, percentage branching and terminal fructose:glucose ratio that anticipates or renders obvious the claimed limitations. Given the blaze marks in Sang, Mays and Tanaka 1979, it would be obvious to look to Tanaka 1980 for a fully characterized levan that would reasonably be suitable for use in a method of treating obesity such as disclosed in Sang, thereby arriving at the instant invention. Moreover, it would have been obvious to expand the method of Sang to treat hypertension as well as obesity because Sang discloses that obesity and hypertension are closely correlated.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the rejection over Sang/Mays/Tanaka 1979/Tanaka 1980, has been fully considered but is not persuasive.
Applicant argues that Tanaka 1980 does not disclose the information as asserted by the Office because Figure 5 of Tanaka 1980 does not contain the data as tabulated in the Office action. Applicants’ argument is not persuasive because while the tabulated data is not expressly disclosed by Tanaka 1980, it can be derived from the graphics in Figure 5, where each open circle represents a fructose, each filled circle represents a glucose, each open circle is connected by a 2-6 linkage and each arrow represent a 1-2 linkage. For instance, taking into consideration Figure 5a, there are 45 fructose and 1 glucose, with forty-four 2-6 linkages and a single 1-2 linkage. This yields a 1-2 linkage percentage of 1/45 x 100=2.22% and a 2-6 linkage percentage of 97.8%. In Figure 5a, there are 3 terminal fructose and one terminal glucose, giving a terminal unit ratio of fructose:glucose of 3:1. Moreover, given the molecular weight of glucosyl and fructosyl, at 163 Da and taking into account the terminal hydroxyl groups, the molecular weight of the levan in Figure 5a is 7.53 kDa. The values of the structures in Figure 5b and 5c, are computed similarly. The range of values derived from Tanaka 1980 overlaps that of the instant claims.
Applicant further argues that the specification presents evidence of unexpected results showing that the administration of levan with molecular weight and linkage pattern, as claimed, yields surprising anti-obesity treatment. Applicants argument is not persuasive because the anti-obesity data only compares treatment with low molecular weight levan to treatment without levan. There are no experiments comparing the effectiveness against obesity for administering levans across a range of molecular weights. The conclusion drawn from the data is that the presence of levan is critical but no conclusion can be made regarding a levan with a “low” molecular weight being more or less effective than a levan having any other molecular weight. The presence of levan in an anti-obesity treatment is taught by the prior art. Thus, the data presented in the specification are not unexpected.
The rejection is still deemed proper and is maintained.
New Rejections
Claim Rejections - 35 USC § 112 – Written Description
The following is a quotation of 35 U.S.C. 112(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.
Claims 18 and 22 are rejected under 35 U.S.C. 112(a), 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 18 and 22 recites that the levan is produced by a Bactrocera oleae levansucrase. Applicant asserts that ¶0142 of the specification contains support for this limitation. However, ¶0142 of the specification only has support for levansucrase produced from Bacillus amyloliquefaciens, Capnocytophaga ochracea or Gluconobacter oxydans. Support for a levansucrase produced from Bactrocera oleae does not exist in ¶0142 or anywhere else in the specification. Thus, this limitation constitutes new matter.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new and/or modified 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 extension fee 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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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