DETAILED CORRESPONDENCE
Application Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Support for the amendments are within the instant application specification.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/6/2026 has been entered.
Applicant’s amendment to the claims filed on 7/6/2026 in response to the Final Rejection mailed on 4/3/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 30-31, 34, 52-58 are pending.
Claims 1-29, 32-33, 35-51 are canceled.
Applicant’s remarks filed on 7/6/2026 in response to the Final Rejection mailed on 4/3/2026 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Withdrawn Rejections
The rejection of claims 30-31, 34 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of Applicant’s amendment of claim 30 to remove the recitation ‘having a sucrose content of less than 5% by weight, as measured after the wet diffusion extraction step.’
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 (WO 2015182530 A1, Date Published: 12/03/2015; cited on PTO-892 filed 12/19/2023) {herein Kazunori} is withdrawn in view of Applicant’s recitation of ‘…the prebiotic phytonutrient fiber material and the Bacillus coagulans spores are administered together as a synbiotic composition…’ in new claim 53 and newly added claim 57.
Maintained 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.
The rejection of claims 30-31, 34, 52-58 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 is maintained. The rejection has been modified in view of Applicant’s amendment of claim 30 to recite ‘does not significantly degrade bioactive molecules; enhance water retention properties’ and the recitation of ‘about’ in new claim 56.
Regarding claim 30 (claims 31, 34, 52-58 dependent therefrom) the phrases "…does not significantly degrade bioactive molecules…” and “…enhance water retention properties…" renders the claim indefinite. The recitation ‘significantly’ is a subjective term, therefore one cannot expressly identify the metes and bounds of the term ‘significantly.’ While the term ‘enhances’ needs a comparative to fully understand the scope of the invention. Appropriate correction is suggested.
Claim 53 (claim 57 dependent therefrom) recites the limitation " the dried prebiotic whole plant phytonutrient fiber material" in line 4. There is insufficient antecedent basis for this limitation in the claim as there is no prior recitation of ‘whole plant phytonutrient’ within the instant application claim 30, upon which claim 53 depends. Appropriate correction is suggested.
The term “about” in claim 56 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim and specification The term “about” in claim 56 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, one is unable to ascertain the limitations of ‘wherein the pectin is present as about 10% of cell walls of the prebiotic phytonutrient fiber material.’ Appropriate correction is suggested.
Claim Interpretation
Claims 30-31, 34, 52-58 have embedded within them, a product by process limitation. Therefore, Claims 30-31, 34, 52-58 are interpreted as a method for the prophylaxis or treatment of the effects, symptoms or inflammatory states of inflammatory bowel disease in a subject using a prebiotic phytonutrient fiber material extracted from sugarcane which is a sucrose-reduced fiber and at least one probiotic bacterial strain, wherein said probiotic bacterial strain is spore- forming, heat stable and acid stable, wherein said probiotic bacterial strain is Bacillus coagulans.
BIOGEN MA INC., v. EMD SERONO, INC., PFIZER INC., No. 19-1133 (Fed. Cir. 2020)
There is no logical reason why the nesting of a product-by-process limitation within a method of treatment claim should change how novelty of that limitation is evaluated……….The nesting of the product-by-process limitation within a method of treatment claim does not change the proper construction of the product-by-process limitation itself.
New 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.
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 30-31, 34, 52-58 are newly rejected 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 Pandey et al (2015, J Food Sci Technol, Examiner cited) {herein Pander} as evidence by Marques et al (2018, frontiers in plant science, Examiner cited) {herein Marques}. The new rejection is necessitated by the recitation of ‘…the prebiotic phytonutrient fiber material and the Bacillus coagulans spores are administered together as a synbiotic composition…’ in new claim 53 and newly added claim 57.
Claims 30-31, 34, 52-58 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, 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 drying process performed using a vortex dryer, 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. As indicated above, how the prebiotic being a sucrose reduced sugarcane fiber is achieved is a product by process limitation - In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), states, "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See also MPEP 2113
With respect to claims 30, 54-56, 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). It is well-known in that art that sugar cane fiber is inherently a lignocellulosic biomass made of a structural combination of cellulose, hemicellulose, and lignin (lignose), which natively include pectin, xylan, and arabinoxylan polymers, as recited in the instant application claim 55. The evidentiary reference of Marques is cited to demonstrate that the cell walls of sugar cane contain 10% pectin (page 2, column 1, para 3), as recited in the instant application claim 56. 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 retaining 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). It is preferred that the drying step be a rapid vortex (para 0046)., 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,’ and also teaches methods of ultimately reducing the sucrose content of the phytonutrient fiber material which will result in bioactive molecules which are not degraded, then said sugar cane fiber would inherently have a sucrose content of less than 5% by weight, as measured after the wet diffusion extraction step, resulting in little biomolecule degradation. Since the Office does not have the facilities for examining and comparing Applicants’ sucrose content with the sucrose content of the prior art, the burden is on the Applicant to show a novel or unobvious difference between the claimed method and the method of the prior art (i.e., that the sucrose content of the prior art does not possess the same activity of the claimed sucrose content). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594. 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). Ball does not teach a method wherein the synbiotic composition is a pressed pellet comprising 0.5-5.0 g of the synbiotic composition (claim 57).
With respect to claims 30, 34, Pandey 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 7582, column 1, para 4). Bacillus coagulans is a lactic acid bacteria (page 7582, column 2, para 2). 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.
With respect to claims 52, 58, Pandey teaches probiotic strains such as Bacillus coagulans are useful for reducing IL-6 is patients with Crohn’s Disease (page 7581, column 2, para 3). It is well-known in the art that TNF- α is similar to IL-6, which is taught by Pandey, as both are major pro-inflammatory cytokines. As such, it would be obvious to one of ordinary skill in the art that administering a composition consisting of Bacillus coagulans would inherently reduce TNF- α within the proximal colon and/or distal colon, as recited in the instant application claim 58. Therefore, since the art 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, it is the Examiners position that said method would inherently reduce one or more pro- inflammatory cytokines and TNF-α in the colon. Since the Office does not have the facilities for examining and comparing Applicants’ cytokines with the cytokines of the prior art, the burden is on the Applicant to show a novel or unobvious difference between the claimed method and the method of the prior art (i.e., that the cytokines of the prior art do not possess the same activity of the claimed cytokines). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
With respect to claim 53, Pandey teaches a method wherein synbiotics such as probiotic strains: Bifidobacterium, Lactobacilli, S. boulardii, B. coagulans are combined with prebiotics plant fibers such as FOS, GOS, XOS, inulin, fructans as the probiotics are favorable to the gut microflora and when ingested, exert a positive influence on host’s health or physiology (page 7577, column 2, para 2).
With respect to claim 57, Ball teaches a method wherein sugarcane composition can be in the form of dried pellets (para 0063 and 0064). Although the references of Ball in view of Pandey do not explicitly teach the limitations of claim 57 (wherein the synbiotic composition is a pressed pellet comprising 0.5-5.0 g of the synbiotic composition), 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 synbiotic composition of the pellet depending on the particular application. It would be routine for one to arrive at the synbiotic composition for the application they intend on using the pellet. Therefore, the above invention would have been prima facie obvious.
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 Pandey of 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 7582, column 1, para 4).
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 Pandey because Pandey provides the motivation for Ball to use Bacillus coagulans in combination with prebiotic phytonutrient fiber material extracted from sugar cane fibers because said combination facilitates smooth functions of the intestinal environment and improve the viability of the probiotics (abstract). Additionally, Bacillus coagulans in combination with prebiotic phytonutrient fiber material extracted from sugar cane fibers facilitate smooth functions of the intestinal environment (Pandey: abstract), which is the objective of Ball (Ball: abstract), is favorable to the gut microflora and when ingested, exert a positive influence on host’s health or physiology (Pandey: page 7577, column 2, para 2).
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 Pandey would have a reasonable expectation of success to combine both a prebiotic phytonutrient fiber material extracted from sugarcane and a probiotic such as Bacillus coagulans because one of ordinary skill in the art would expect them both to result in a prophylaxis or treatment for inflammatory bowel disease as Pandey teaches dietary fiber and B. coagulans improve bowel movement and promote proper defecation to prevent repeated diarrhea and constipation seen in IBS (abstract, page 7580, column 2, para 4-5). 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, Pandey 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 7582, column 1, para 4). 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: Applicant's arguments filed 7/6/2226 have been fully considered but they are not persuasive. Beginning on p. 4 of Applicants’ remarks, Applicants in summary contends that
Ball is deficient because it does not disclose or suggest a synbiotic composition comprising the dried whole-plant sugarcane phytonutrient fiber combined with dry Bacillus coagulans spores after the low-heat drying process. Ball also does not disclose administration of Bacillus coagulans, does not disclose dry Bacillus coagulans spores, and does not disclose reduction of colonic pro-inflammatory cytokines or TNF-a.
These arguments are found to be not persuasive. Examiner contends that Applicant’s instant application claim 30 is a product by process limitation nested within a method of treatment claim. Therefore, as long as Ball in view of Pandey teaches a prebiotic phytonutrient fiber material extracted from sugar cane, wherein the prebiotic phytonutrient fiber material is a sucrose-reduced sugarcane fiber, having some sort of minimal damage/degradation to the bioactive materials (Ball) combined with administering the probiotic Bacillus coagulans (Pandey), which are administered for treatment of IBS – then the limitations of claim 30 have been met. BIOGEN MA INC., v. EMD SERONO, INC., PFIZER INC., No. 19-1133 (Fed. Cir. 2020) “There is no logical reason why the nesting of a product-by-process limitation within a method of treatment claim should change how novelty of that limitation is evaluated……….The nesting of the product-by-process limitation within a method of treatment claim does not change the proper construction of the product-by-process limitation itself.”Furthermore, Examiner contends that Pandey provides the motivation for Ball to use Bacillus coagulans in combination with prebiotic phytonutrient fiber material extracted from sugar cane fibers because said combination facilitates smooth functions of the intestinal environment and improve the viability of the probiotics (Pandey: abstract), which is the objective of Ball (Ball: abstract).
Applicant contends that Ball reports general digestive-health outcomes and symptom relief in individuals with digestive dysfunction, but Ball does not evaluate IBD inflammatory-state markers, Disease Activity Index, colon shortening, colon weight/body-weight ratio, or colonic cytokine levels.
These arguments are found to be not persuasive. Examiner contends that Applicant does not claim IBD inflammatory-state markers, Disease Activity Index, colon shortening, colon weight/body-weight ratio. Examiner contends that Applicant’s recitation of the reduction of TNF- α within the instant application claim 58 is addressed by Pandey, who teaches probiotic strains such as Bacillus coagulans are useful for reducing IL-6 is patients with Crohn’s Disease (page 7581, column 2, para 3). Since it is well-known that the claimed TNF- α is similar to IL-6 taught by Pandey as both are major pro-inflammatory cytokines, it would be obvious to one of ordinary skill in the art that administering a composition consisting of Bacillus coagulans would have similar effects in reducing TNF- α in the proximal colon and/or distal colon (colonic cytokine levels).
Conclusions
Status of Claims
Claims 30-31, 34, 52-58 are pending.
Claims 1-29, 32-33, 35-51 are canceled.
Claims 30-31, 34, 52-58 are rejected.
No claims are in condition for allowance.
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.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
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