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 .
The amendment filed 10/1/2025 has been entered. Claims 1-3, 5, 7-12, 14-21, 33-35, and 38-40 are pending. Claims 20-21, 33-35, and 38-40 are withdrawn. Prior objections and rejections not included below are withdrawn in view of Applicant’s arguments and amendments.
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, 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 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 1-3, 5, 7-12, and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Harrison (US 8993039).
Regarding Claims 1-3, 5, and 7-9, Harrison teaches a soluble dietary fiber (Column 12, Lines 1-2). Harrison teaches that the fiber contains at least 50% oligomers having a DP of at least 3 (Column 7, Lines 52-62), which encompasses the claimed range of Claims 1, 2, 3, 5, 7, 8, and 9. Note that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 I.
Note that Harrison teaches that the composition may contain greater than 50% of oligosaccharides (that is, fiber), which encompasses the claimed range of at least 97% (Column 2, Line 63).
Harrison teaches a soluble dietary fiber according to Claim 1 but does not discuss the specific linkage pattern of the claim, the ratio of 6-linked to 4-linked residues, or the ratio of alpha to beta anomeric protons.
However, Harrison teaches treatment of dextrose (Column 5, Lines 25-29) at 90-100% solids concentration with a combination of phosphoric and hydrochloric acid, followed by heating at a temperature of at least 140 degC for 0.1-15 minutes (Column 6, Lines 60-65). Harrison teaches that the pH is adjusted to 1-2.5 with the acids (Column 6, Line 43). Note that a temperature of “at least” 140 degC encompasses, e.g. 227 degC.
Given that the instant Specification teaches at [118] that a dextrose feed is combined with phosphoric and hydrochloric acid to a pH of 2.2-2.4, followed by condensation to a solids content of 92-96%, and reacted for 2-3 minutes at a temperature of 227 degC to generate the claimed linkage pattern, the ratio of 6-linked to 4-linked residues, and the ratio of alpha to beta anomeric protons, there is an expectation that the product of Harrison have the property of the linkage pattern as claimed. Note that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." See MPEP 2112.01 I.
Regarding Claim 10, Harrison teaches that the soluble dietary fiber is made from dextrose (Column 5, Line 28). Since Harrison teaches that the soluble dietary fiber is made from a dextrose starting material which is processed into dextrose residues (Column 5 Line 48) and then processed into oligomers (Column 5, Line 56-Column 6, Line 22), the soluble fiber of Harrison is interpreted to have “at least 99 wt% dextrose residues on a dry solid basis”, as claimed.
Regarding Claim 11, Harrison teaches the hydrogenation of oligosaccharides to alcohols as an optional step (Column 2, Line 26 and Column 7, Lines 28-33), thus teaching an embodiment wherein the fiber does not comprise sugar alcohols.
Regarding Claims 12 and 14, Harrison does not discuss the molecular weight or polydispersity of the soluble dietary fiber. However, Harrison teaches that molecular weight fractionation can be performed (Column 9, Line 62-Column 10, Line 12) on the product to remove smaller molecular weight species. Harrison additionally teaches a higher molecular weight is desired (Column 5, Lines 15-17). Where Harrison speaks to the effects of molecular weight (e.g. digestibility, Column 9, Line 3), one of ordinary skill would have been able to have adjusted the molecular weight and PDI to have arrived at ratios as claimed through no more than routine experimentation. Additionally, it would have been obvious to one of ordinary skill to have adjusted the PDI of the soluble dietary fiber, since one of ordinary skill would understand that the properties of a polymer are affected by the molecular weight and the distribution of molecular weights.
Regarding Claim 15, 16, and 17, Harrison teaches a soluble dietary fiber according to Claim 1 but does not discuss the specific linkage pattern of the claim, the ratio of 6-linked to 4-linked residues, or the ratio of alpha to beta anomeric protons.
However, Harrison teaches treatment of dextrose (Column 5, Lines 25-29) at 90-100% solids concentration with a combination of phosphoric and hydrochloric acid, followed by heating at a temperature of at least 140 degC for 0.1-15 minutes (Column 6, Lines 60-65). Harrison teaches that the pH is adjusted to 1-2.5 with the acids (Column 6, Line 43). Note that a temperature of “at least” 140 degC encompasses, e.g. 227 degC.
Given that the instant Specification teaches at [118] that a dextrose feed is combined with phosphoric and hydrochloric acid to a pH of 2.2-2.4, followed by condensation to a solids content of 92-96%, and reacted for 2-3 minutes at a temperature of 227 degC to generate the claimed linkage pattern, the ratio of 6-linked to 4-linked residues, and the ratio of alpha to beta anomeric protons, there is an expectation that the product of Harrison have the property of the linkage pattern as claimed. Note that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." See MPEP 2112.01 I.
Regarding Claims 18 and 19, Harrison teaches a soluble dietary fiber but does not discuss the glass transition or viscosity of the fiber.
However, Harrison teaches treatment of dextrose (Column 5, Lines 25-29) at 90-100% solids concentration with a combination of phosphoric and hydrochloric acid, followed by heating at a temperature of at least 140 degC for 0.1-15 minutes (Column 6, Lines 60-65). Harrison teaches that the pH is adjusted to 1-2.5 with the acids (Column 6, Line 43). Harrison additionally teaches that molecular weight fractionation is performed (Column 9, Line 62-Column 10, Line 12) on the product, and that molecular weight affects features such as digestibility (Column 9, Line 3).
Given that the instant Specification teaches at [118] that a dextrose feed is combined with phosphoric and hydrochloric acid to a pH of 2.2-2.4, followed by condensation to a solids content of 92-96%, and reacted for 2-3 minutes at a temperature of 227 degC to generate the glass transition and viscosity properties, and additionally where Harrison teaches fractionation of the product to separate products of a desired molecular weight, there is an expectation that the product of Harrison have the property of viscosity and glass transition temperature as claimed. Note that one of ordinary skill would understand that viscosity and glass transition are affected by the molecular weight of the product. Additionally note that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." See MPEP 2112.01 I.
Claims 1-3, 5, 7-12, and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gibson (US 2019/0290675 A1).
Regarding Claims 1-3, Gibson teaches a glycan polymer (which is a fiber, Abstract) which is soluble [0390]. Gibson teaches an embodiment wherein greater than 98% of the polymer is, e.g. DP3-10 [0335] and 100% of the composition is the polymer [0422].
Gibson teaches that the polymer comprises a mixture of alpha-and beta-glycosidic bonds [0357], which encompasses the claimed linkage pattern. Gibson additionally teaches that the bonds may be any mixture of glycosidic bonds, including (1,6), (1,4), (1,3), (1,2) [0360], and (2,4) [0363] linkages.
Note that while the instant Specification at [38] states that the linkage pattern “can be important to the properties” of the fiber, Applicant has not demonstrated that the specific linkage pattern is for any particular purpose or solves any stated problem. Gibson teaches that linkage patterns affect, e.g. enzymatic digestion [0291], branching [0352] and solubility [0407] in the polymer. One of ordinary skill would have been able to have adjusted the linkage pattern of the fiber to arrive at the linkage pattern as claimed through no more than routine experimentation, and additionally since Gibson teaches that a myriad of possibilities exist for linkage patterns within a glycan polymer.
Note that additionally since Applicant has not demonstrated that the specific linkage pattern is for any particular purpose or solves any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the method disclosed by the prior art by normal optimization procedures known in the art.
Regarding Claim 5, Gibson teaches that the glycan polymer contains greater than 98% of DP3-10 units [0335], which encompasses less than 2% DP1 and DP2 content.
Regarding Claims 7, 8, and 9, Gibson teaches that the glycan polymer contains greater than 98% of DP3-10 units [0335], which encompasses less than 0.5% DP1 and DP2 content (as in Claim 7), less than 1.0 wt% DP2 (as in Claim 8), and less than 0.50 wt% DP1 (as in Claim 9). Note that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 I.
Regarding Claim 10, Gibson teaches that the polymer is made of 99% glucose subunits, which encompasses dextrose (i.e., D-glucose) subunits [0016-0018 and 0366].
Regarding Claim 11, Gibson teaches embodiments wherein the glycan subunits do not comprise sugar alcohols [0228].
Regarding Claim 12, Gibson teaches that the soluble dietary fiber has a molecular weight in the range of, e.g. 1,500, which lies within the claimed range [0349].
Regarding Claim 14, Gibson teaches that the polymer is fractionated by molecular weight [0166,0325] but does not discuss the polydispersity.
However, it would be obvious to one of ordinary skill to have selected any polydispersity, including one of less than 1.8, since polydispersity is known in the art to affect e.g. solubility of a polymer.
Note that since Applicant has not demonstrated that the specific polydispersity is for any particular purpose or solves any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the method disclosed by the prior art by normal optimization procedures known in the art.
Regarding Claim 15, Gibson teaches that the polymer comprises a mixture of alpha-and beta-glycosidic bonds [0357], which encompasses the claimed linkage pattern. Gibson additionally teaches that the bonds may be any mixture of glycosidic bonds, including (1,6), (1,4), (1,3), (1,2) [0360], and (2,4) [0363] linkages.
Note that while the instant Specification at [38] states that the linkage pattern “can be important to the properties” of the fiber, Applicant has not demonstrated that the specific linkage pattern is for any particular purpose or solves any stated problem. Gibson teaches that linkage patterns affect, e.g. enzymatic digestion [0291], branching [0352] and solubility [0407] in the polymer. One of ordinary skill would have been able to have adjusted the linkage pattern of the fiber to arrive at the linkage pattern as claimed through no more than routine experimentation, and additionally since Gibson teaches that a myriad of possibilities exist for linkage patterns within a glycan polymer.
Note that additionally since Applicant has not demonstrated that the specific linkage pattern is for any particular purpose or solves any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the method disclosed by the prior art by normal optimization procedures known in the art.
Regarding Claim 16, Gibson teaches that the polymer may contain e.g. 100% of glycosidic bonds which are a mixture of (1,4) and (1,6) bonds [0363], which encompasses a ratio of 6-linked and 4-linked glucopyranosyl residues that is at least 2.
Note that while the instant Specification at [38] states that the linkage pattern “can be important to the properties” of the fiber, Applicant has not demonstrated that the specific linkage pattern is for any particular purpose or solves any stated problem. Gibson teaches that linkage patterns affect, e.g. enzymatic digestion [0291], branching [0352] and solubility [0407] in the polymer. One of ordinary skill would have been able to have adjusted the linkage pattern of the fiber to arrive at the linkage pattern as claimed through no more than routine experimentation, and additionally since Gibson teaches that a myriad of possibilities exist for linkage patterns within a glycan polymer [0363].
Regarding Claim 17, Gibson teaches a ratio of alpha:beta glycosidic bonds in a ratio of 0.1-1 to 10:1 [0359], which encompasses the claimed range.
Regarding Claim 18, Gibson does not discuss the glass transition temperature. However, given that Gibson teaches a soluble [0390] glycan polymer (Abstract), which is a soluble dietary fiber, having a fiber content and a DP1 + DP2 content as claimed, there is an expectation that the product of the prior art have the property of glass transition temperature as claimed. Note that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." See MPEP 2112.01 I.
Regarding Claim 19, Gibson does not discuss the viscosity. However, given that Gibson teaches a soluble [0390] glycan polymer (Abstract), which is a soluble dietary fiber, having a fiber content and a DP1 + DP2 content as claimed, there is an expectation that the product of the prior art have the property of glass transition temperature as claimed. Note that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." See MPEP 2112.01 I.
Response to Arguments
Applicant’s arguments filed 10/1/2025 have been fully considered but they are not persuasive.
Applicant argues that Gibson does not disclose the claimed soluble dietary fiber; namely, Gibson fails to disclose the claimed linkage pattern (Page 7, Part A of Remarks).
This argument is not convincing. As discussed above in regards to Claim 1, Gibson teaches that linkage patterns affect, e.g. enzymatic digestion [0291], branching [0352] and solubility [0407] in the polymer. One of ordinary skill would have been able to have adjusted the linkage pattern of the fiber to arrive at the linkage pattern as claimed through no more than routine experimentation, and additionally since Gibson teaches that a myriad of possibilities exist for linkage patterns within a glycan polymer.
Note that additionally since Applicant has not demonstrated that the specific linkage pattern is for any particular purpose or solves any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the method disclosed by the prior art by normal optimization procedures known in the art.
Applicant additionally argues that Harrison teaches 10-70% weight fiber whereas the instant Claim requires greater than 97%, and additionally that Harrison fails to disclose the claimed linkage pattern (Page 7, Part B of Remarks).
This argument is not convincing. First, regarding the limitation of the weight percent of fiber, Harrison teaches that the composition may contain greater than 50% of oligosaccharides (that is, fiber), which encompasses the claimed range of at least 97% (Column 2, Line 63). Second, regarding the linkage pattern, Harrison teaches treatment of dextrose (Column 5, Lines 25-29) at 90-100% solids concentration with a combination of phosphoric and hydrochloric acid, followed by heating at a temperature of at least 140 degC for 0.1-15 minutes (Column 6, Lines 60-65). Harrison teaches that the pH is adjusted to 1-2.5 with the acids (Column 6, Line 43). Note that a temperature of “at least” 140 degC encompasses, e.g. 227 degC.
Given that the instant Specification teaches at [118] that a dextrose feed is combined with phosphoric and hydrochloric acid to a pH of 2.2-2.4, followed by condensation to a solids content of 92-96%, and reacted for 2-3 minutes at a temperature of 227 degC to generate the claimed linkage pattern, the ratio of 6-linked to 4-linked residues, and the ratio of alpha to beta anomeric protons, there is an expectation that the product of Harrison have the property of the linkage pattern as claimed. Note that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." See MPEP 2112.01 I.
Applicant additionally argues (Page 8, Part C of Remarks) that there is nothing in Gibson or Harrison that would suggest to a person having ordinary skill how to provide a soluble dietary fiber with the claimed linkage pattern.
This argument is not convincing. First, Harrison teaches a method for producing oligosaccharides, or fibers, with similar processing parameters as those described in the instant Specification (see above in regards to part B of Remarks). Second, as noted by the Applicant, Gibson teaches various methods for producing glycan polymers, and additionally teaches that the linkage pattern affects enzymatic digestion [0291], branching [0352] and solubility [0407]. Where Gibson speak to the effects imparted by the linkage pattern, one of ordinary skill would have been able to have adjusted the linkage pattern to have arrived at the composition as claimed through no more than routine experimentation.
Applicant additionally argues (Page 9, Part D of Remarks) that a person of ordinary skill would not have any reason to modify the linkage pattern.
This argument is not convincing. Harrison and Gibson both teach that modifying linkage pattern affects the properties of the oligosaccharides, or fibers. One of ordinary skill would have been able to have adjusted linkage pattern(s) to have arrived at the pattern(s) as claimed through no more than routine experimentation.
Applicant additionally argues (Page 12, Part E of Remarks) that the specific claimed linkage pattern is important in determining the properties of the dietary fiber, such as viscosity.
This argument is not convincing. Note that Harrison (Column 7, Lines 1-12 and Column 8, Line 13) and Gibson [0407] both teach that modifying the linkage pattern, and therefore the geometry of the molecule, is known to affect the viscosity. One of ordinary skill would have been able to have adjusted the linkage pattern to arrive at the pattern as claimed (and the alleged advantageous viscosity properties) as claimed through no more than routine experimentation. Additionally, while the instant Specification provides a comparison to commercial fibers (e.g. Page 7), no comparison has been provided against the closest prior art, nor have details been provided regarding the commercial fibers (e.g. linkage pattern or method of synthesis) such that one having ordinary skill could extrapolate to the methods of the prior art.
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 DEBORAH LIU whose telephone number is (571)270-5685. The examiner can normally be reached 12-8 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.L./ Examiner, Art Unit 1791
/Nikki H. Dees/ Supervisory Patent Examiner, Art Unit 1791
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