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 does not have support for the amendment ‘…having a sucrose content of less than 5% by weight…’ (claim 30). See new 112a rejection.
Applicant’s amendment to the claims filed on 1/13/2026 in response to the Non-Final Rejection mailed on 9/16/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 30-31, 34, 38-50 are pending.
Claims 38-50 are withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-29, 32-33, 35-37, 51 are canceled.
Claims 30-31, 34 are now under examination.
Applicant’s remarks filed on 1/13/2026 in response to the Non-Final Rejection mailed on 9/16/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Withdrawn Rejections
Claims 30-31, 34 are newly rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of Applicant’s amendment of claim 30 to recite ‘having a sucrose content of less than 5% by weight’ and ‘drying is performed at a temperature not exceeding 70 C, for a duration of 10 to 30 seconds.’
New Claim Rejections - 35 USC § 112
Claims 30-31, 34 are newly rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The new rejection is necessitated by Applicant’s amendment of claim 30 to recite ‘having a sucrose content of less than 5% by weight’ and ‘“wherein the process does not significantly degrade bioactive molecule 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Lines 5-6 of claim 30 recites ‘having a sucrose content of less than 5% by weight’ which is not properly described in the application filed. Applicant does not state the sucrose content within the instant application. It is suggested that Applicant provide the support for the recitation ‘having a sucrose content of less than 5% by weight.’
Line 12 of claim 30 recites ‘wherein the process does not significantly degrade bioactive molecules’ which is not properly described in the application filed. Applicant does not properly state the degradation of bioactive molecules within the instant application. It is suggested that Applicant provide support for the recitation ‘wherein the process does not significantly degrade bioactive molecule.’
RESPONSE TO REMARKS: This argument is found to be moot in view of the new rejection. Examiner contends that the recitation ‘having a sucrose content of less than 5% by weight’ within claim 30 of the instant application is new matter as it has not been properly disclosed in the instant application.
Maintained 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 rejection of claims 30-31, 34 under 35 U.S.C. 103 as being unpatentable over Ball et al. (US 2016/0067299 A1, Publication Date: March 10. 2016; cited on PTO-892 dated 9/16/2025) {herein Ball} in view of Kazunori et al. (WO 2015182530 A1, Date Published: 12/03/2015; cited on PTO-892 filed 12/19/2023) {herein Kazunori} is maintained. The rejection has been modified in view of Applicant’s amendment of claim 30 to recite ‘…having a sucrose content of less than 5% by weight…’ and ‘…wherein the drying is performed at a temperature not exceeding 70 C, for a duration of 10 to 30 seconds, sufficient to reduce the wet weight from 40-80% to less than 10%, and wherein the process does not significantly degrade bioactive molecules…’
As amended, claims 30-31, 34 are drawn to ‘a method for the prophylaxis or treatment of the effects, symptoms or inflammatory states of inflammatory bowel disease in a subject, the method comprising administering to the subject (a) a prebiotic phytonutrient fiber material extracted from sugarcane, wherein the prebiotic phytonutrient fiber material is a sucrose-reduced sugarcane fiber, having a sucrose content of less than 5% by weight, as measured after the wet diffusion extraction step prepared by a process comprising: subjecting sugarcane to at least one wet diffusion step to extract one or more sugars to produce a residual fiber material, wherein the nutrient content of the residual fiber material is maintained during the extraction; and subjecting the residual fiber material to a rapid, low-heat drying process wherein the drying is performed at a temperature not exceeding 70 C, for a duration of 10 to 30 seconds, sufficient to reduce the wet weight from 40-80% to less than 10%, and wherein the process does not significantly degrade bioactive molecules in the residual fiber material and to enhance water retention properties of said residual fiber material; and (b) at least one probiotic bacterial strain, wherein said probiotic bacterial strain is spore- forming, heat stable and acid stable, and is Bacillus coagulans.’
With respect to claim 30, Ball teaches a method wherein dietary fiber material extracted from sugarcane in the manufacture of a food product that is formulated to ameliorate the effects of intestinal tract disorders such as Irritable Bowel Syndrome (IBS) (abstract). The sugar cane fiber is prepared via a process including the steps of: subjecting the sugar cane material to at least one wet diffusion step to separate sugars from a residual fiber material; and subjecting the residual fiber material to a rapid, low-heat drying process thereby to retain the biologically active molecules in the fiber, and to enhance the water retention properties of said residual fiber product (para 0031). The wet extraction step (Examiner interpreted drying step) is carried out at a temperature in the range of 25C to 70C (para 109). Although the references of Ball does not explicitly teach the limitation of drying for a duration of 10 to 30 seconds as in claim 30. MPEP 2144.05 states"[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 IIA)." One of ordinary skill would desire to optimize the drying temperature of the sugar cane fiber depending on the particular application. It would be routine for one to arrive at the time for drying for the application they intend on using the sugar cane fiber. Therefore, the above invention would have been prima facie obvious.
Furthermore, absent evidence otherwise, it is the Examiner’s position that since Ball teaches the structure of ‘a method for the prophylaxis or treatment of the effects, symptoms or inflammatory states of inflammatory bowel disease in a subject,’ then said sugar cane fiber would necessarily have a sucrose content of less than 5% by weight, as measured after the wet diffusion extraction step. Additionally, it is the Examiner’s position that since Ball teaches the structure of a method of drying the sugar cane at low heat (25C to 70C), it is the Examiner’s position that the sugar cane taught by Ball would necessarily have a reduced weight from 40%-80% to less than 10%, wherein the process does not significantly degrade bioactive molecules.
With respect to claim 31, Ball teaches a method wherein the fiber is pressed into a pellet (paragraph 0060 and 0069). Ball also teaches a method wherein the fiber is mixed with a flavored drink (paragraph 0063 and 0086). In addition, Ball teaches a method wherein the supplement is prepared in a solid flavored meal such as a biscuit or a bar (paragraph 0065).
However, Ball does not teach the method of claim 30, (b) at least one probiotic bacterial strain is added to the sugarcane fiber material, wherein said probiotic bacterial strain is spore-forming, heat stable and acid stable, and is Bacillus coagulans (claim 30) and the method of claim 34, further comprising the step of administering to the subject at least one postbiotic (claim 34).
With respect to claim 30, Kazunori teaches a method wherein Bacillus coagulans, a probiotic spore forming bacterial strain, and dietary fiber are administered to patients with irritable bowel syndrome to improve their intestinal health (abstract; page 2, para 1; page 10, para 3 and 5).
With respect to claim 34, Kazunori also teaches a method wherein the lactic acid produced by Bacillus coagulans and dietary fiber stabilize the intestine of subjects with IBS by allowing the irritable intestine to stabilize (page 7, para 4). It is known by those of ordinary skill in the art that lactic acid from Bacillus coagulans is a postbiotic as lactic acid is a metabolic byproduct produced by B. coagulans. As such, Examiner is interpreting the lactic acid taught by Kazunori to be a postbiotic.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Ball et al. of a method wherein dietary fiber material extracted from sugarcane in the manufacture of a food product that is formulated to ameliorate the effects of intestinal tract disorders such as Irritable Bowel Syndrome (IBS) (abstract). Or combine the teachings of Kazunori which teaches a method wherein Bacillus coagulans cells a probiotic that is highly resistant to gastric acid and has the ability to reach the intestine to improve the intestinal environment (page 2, paragraph 1) is added to the sugar cane fiber material.
One of ordinary skill in the art would be motivated to either use the teachings of Ball et al. by itself or combine the teachings of Kazunori because Kazunori provides the motivation for Ball to use Bacillus coagulans as a probiotic since it is highly resistant to gastric acid and has the ability to reach the intestine (page 2, paragraph 1). One of ordinary skill in the art knowing the benefit of the treatment or prophylaxis of the effects, symptoms or inflammatory states of inflammatory bowel disease in a subject based on the teachings of Ball and Kazunori would have a reasonable expectation of success to combine both a prebiotic phytonutrient fiber material extracted from sugarcane and a probiotic because one of ordinary skill in the art would expect them both to result in a prophylaxis or treatment for inflammatory bowel disease as Kazunori teaches dietary fiber and B. coagulans, improve bowel movement and promote proper defecation to prevent repeated diarrhea and constipation seen in IBS by promoting the appropriate amount of lactic acid production by B. coagulans within the intestine (Kazunori; abstract and page 7, para 1-3). Furthermore, MPEP 2144.06.I states “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).”
One of skill in the art would have a reasonable expectation of success to make and use the claimed method of the prophylaxis or treatment of the effects, symptoms or inflammatory states of inflammatory bowel disease in a subject because Ball teaches a method wherein dietary fiber material extracted from sugarcane in the manufacture of a food product that is formulated to ameliorate the effects of intestinal tract disorders such as Irritable Bowel Syndrome (IBS) (abstract). Whereas, Kazunori teaches a method wherein Bacillus coagulans is a probiotic that is highly resistant to gastric acid and has the ability to reach the intestine to improve intestinal health (page 2, paragraph 1). Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Beginning on p. 6 of Applicant’s remarks, Applicant in summary contends that IBS taught by Ball is different than IBD of the instant application. Therefore, Ball does not teach the treatment of IBD using sugar cane fiber. Applicant contends that Ball is directed to dietary fiber supplementation for individuals with coeliac disease and IBS. It does not mention IBD, Crohn's disease, or ulcerative colitis, nor does it address the unique risks and dietary requirements of IBD patients.
This argument is found to be not persuasive. Examiner reminds Applicant that the claims are drawn to ‘a method for the prophylaxis or treatment of the effects, “symptoms” or inflammatory states of inflammatory bowel disease in a subject.’ It is well-known by those of ordinary skill in the art that the symptoms of IBD include, but are not limited to diarrhea, abdominal pain, weight-loss, etc. Examiner contends that Ball teaches a method wherein sugar cane fiber is used to treat symptoms such as, but not limited to: diarrhea (para 0007), stomach cramps (para 0010), abdominal pain (para 0013) and weight loss (para 0018) which are the same symptoms of IBD. As such, absent evidence otherwise, it is the Examiner’s position that it would be obvious to one of ordinary skill in the art that the sugar cane fiber taught by Ball would necessarily be utilized for the prophylaxis or treatment of the symptoms of IBD as Ball teaches said symptoms are treated by the utilization of sugar cane fiber (para 0030 and para 0034).
Applicant contends that the rationale for using sugarcane-derived fiber by Ball, et al. is based on the need for a hypoallergenic, gluten-free, and gut-friendly fiber source for individuals who cannot tolerate conventional fibers due to functional or allergic sensitivities-not due to active mucosal inflammation or structural disease.
This argument is found to be not persuasive. Examiner contends that Applicant did not claim sugarcane derived fiber for the treatment or prophylaxis of active mucosal inflammation or structural disease. Examiner contends that Applicant is claiming a method for the prophylaxis or treatment of the effects, symptoms or inflammatory states of inflammatory bowel disease in a subject, which is sufficiently broad and includes symptoms such as: bloating, diarrhea, weightless, etc, of which as taught by Ball.
Applicant contends that literature demonstrates that fiber supplementation is not universally beneficial for IBD, and may in fact be harmful in certain cases. The skilled person would not have had a reasonable expectation of success in applying Ball, et al.'s teaching regarding IBS to IBD, given the distinct pathophysiology, risks, and dietary management requirements of these conditions. The cited references collectively rebut the Examiner's position and support the patentability of the claimed invention.
This argument is found to be not persuasive. Examiner contends that Applicant has not sufficiently demonstrated that the sugar cane fiber taught by Ball would adversely impact a subject with IBD. The cited references in ‘Applicant Arguments/Response’ do not provide evidence that the ‘sugar cane fiber’ taught by Ball would have an adverse effect on subjects with IBD. Examiner contends that Ball teaches there are a number of advantages to using sugar cane fiber (para 0032). Firstly, no adverse allergic effects have ever been recorded with this source (para 0032). Also, this fiber source has been shown to improve gut lining health over and above other sources of fiber (para 0032). It contains benefits of both soluble and insoluble fiber and has a ratio of fibers that more accurately represents natural foods than other products (para 0032). It is also high in other micronutrients such as iron and has the ability to protect antioxidants (para 0032).
Conclusion
Status of Claims
Claims 30-31, 34, 38-50 are pending.
Claims 38-50 are withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-29, 32-33, 35-37, 51 are canceled.
Claims 30-31, 34 are pending.
Claims 30-31, 34 are rejected.
No claims are in condition for allowance.
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 ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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