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 .
Status of Claims
Claims 73-92 are pending in this application. Claims 73-79 and 90-92 are under examination. Claims 80-89 are withdrawn. Any objections or rejections not repeated below have been withdrawn.
Information Disclosure Statement
The information disclosure statement filed 12/02/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The non-patent literature publication Zhou, Love Life, from Jiaotong University press has been placed in the application file, but the information referred to therein has not been considered.
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 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.
Claim 73-74, 79 and 90-92 are rejected under 35 U.S.C. 103 as being unpatentable over Demichele et al. WO 2019018493.
Regarding claims 73 and 74, Demichele teaches an ulcerative colitis (UC) dietary composition (a nutritional composition for modulating or reducing inflammation in an individual in need; Abstract, [0005]), as required by claim 73.
It is noted the limitation “low” content is defined by the specification in the last paragraph on pg. 17 and at the top of pg. 18 as any value being zero, or otherwise smaller than 0.5% and otherwise smaller than about 7.5%. Therefore, “low content” will be defined as any value less than 7.5%.
It is noted the limitation “high” content is defined by the specification in the first full paragraph on pg. 18 as any value greater than 10%. Therefore, “high content” will be defined as any value greater than 10%.
Demichele teaches the composition comprises (a) low content of at least one ingredient selected from the group consisting of heme animal-based protein (protein source from animal meat; [0089]). Demichele discloses the total concentration of protein is in the composition ranging from about 0.25% to about 55% [0087-0088], which overlaps the amount considered to be “low content” of 0-7.5%, as required by claim 73, and overlaps wherein the low content is smaller than 2.5%, as required by claim 74. 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). It is noted that while Demichele recognizes animal meat as a protein source it does not require animal meat to be the protein source [0089]. Thus, Demichele discloses a low content of heme animal-based protein, or in other words 0% heme animal-based protein (animal meat; [0089]), which is within the claimed range of 0-7.5%, as required by claim 73, and smaller than 2.5%, as required by claim 74.
Demichele discloses the composition comprises (b) high content of at least one ingredient selected from the group consisting of fiber (carbohydrate including dietary fibers [0096-0098]), as required by claims 73 and 74. Demichele teaches the fiber (carbohydrate including dietary fibers) is present in an amount from about 5-65% [0097-0098], which overlaps the amount considered to be “high content” of greater than 10%, as required by claims 73 and 74. See MPEP 2144.05(I).
Regarding claim 79, Demichele teaches wherein said formula (a) a ready-to-use medical food, as a stand-alone food stuff, sufficient to provide all dietary and nutritional requirements for an individual (composition with sufficient kinds and amounts of nutrients to provide a sole source of nutrition for use in individuals afflicted with specific diseases or conditions; [0053]).
Regarding claim 90, Demichele teaches the composition, wherein the composition is edible (the nutritional composition is suitable for oral consumption by a human; [0031]).
Demichele teaches the composition comprises a fat component, non-limiting examples of suitable fats include canola oil and MCT oil or any combination thereof [0093]. Demichele does not disclose the specific ranges of canola oil and medium-chain triglyceride (MCT) oil that contribute to the total fat within the composition. However, it would be obvious to a person of ordinary skill in the art to incorporate any amount including the ranges of canola oil and MCT oil as claimed since Demichele discloses that any combination of canola oil and MCT oil can be in the composition [0093].
Further, applicant's attention is directed to In re Levin, 84 USPQ 232 p. 234
This court has taken the position that new recipes or formulas for cooking food
which involve the addition or elimination of common ingredients, or for treating them in
ways which differ from the former practice, do not amount to invention merely because it
is not disclosed that, in the constantly developing art of preparing food, no one else
ever did the particular thing upon which the applicant asserts his right to a patent. In all
such cases, there is nothing patentable unless the applicant by a proper showing further
establishes a coaction or cooperative relationship between the selected ingredients
which produces a new, unexpected, and useful function. In re Benjamin D. White, 17
C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A.
(Patents) 1144, 156 F.2d 189, 70 USPQ 221
Additionally, in Example 2, Table 6 of Demichele, the vegan ready-to-feed product contains two oils, canola oil at about 75% of the total fat and the second oil at about 25% of the total fat [0127]. It would have been obvious to a person of ordinary skill in the art to have applied a similar ratio to another ready-to-feed embodiment envisaged by Demichele to have two oils, canola oil at 75% and MCT oil at 25% since this is a ratio already used by Demichele for canola oil and Demichele has disclosed a possible combination of canola oil and MCT oil [0093], [0127]. The envisaged values for canola oil and MCT oil are within the claimed range.
Regarding claim 91, Demichele teaches the composition comprises carbohydrates and can be present in an amount of about 5%. Demichele also teaches the composition can have combination of carbohydrates where a portion of the carbohydrates comes from pectin [0097-0098]. Thus, the amount of pectin in the composition would be less than 5% or about less than 5 grams per 100 ml of the composition. This overlaps the amount of pectin ranging from about 0.5 to about 2 grams per 100 ml. See MPEP 2144.05(I).
Demichele is silent as to the type of pectin within the composition. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Demichele to use any type of pectin, including apple pectin. See MPEP 2144.08.
Demichele discloses the composition is edible (the composition is a nutritional composition suitable for oral consumption by a human; [0031]).
Regarding claim 92, Demichele teaches the composition comprises whey protein from about 0.25%-55%, or about 0.25 grams to 55 grams per 100 ml of the composition [0087-0089]. This encompasses the claimed amount of 2 grams whey protein per 100 ml of composition. See MPEP 2144.05(I).
Demichele teaches the composition includes a combination of carbohydrates including sucrose, maltodextrin, and pectin, where the total combination can be present in an amount from about 5% to about 65%, or about 5 grams to 65 grams per 100 ml of composition [0096-0097]. Therefore, it would have been obvious to a person of ordinary skill in the art to envisage the claimed amount and combination of carbohydrates where 11 grams per 100 ml of composition comes from sucrose and maltodextrin, and 1 gram per 100 ml of composition comes from pectin, since this would give a total amount of carbohydrates of about 12%, or 12 grams per 100 ml of composition, which is an amount within the disclosed range and with disclosed ingredients of Demichele.
Demichele is silent as to the type of pectin within the composition. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Demichele to use any type of pectin, including apple pectin. See MPEP 2144.08.
Demichele teaches fat in the composition can range from 0-30%, or 0 grams to about 30 grams per 100 ml of composition [0091]. This encompasses the claimed amount of 4.5 grams fat per 100 ml of composition. See MPEP 2144.05(I).
Demichele discloses the composition is edible (the composition is a nutritional composition suitable for oral consumption by a human; [0031]).
Claims 75-78 are rejected under 35 U.S.C. 103 as being unpatentable over Demichele et al. WO 2019018493 in view of Langford et al. US 20090238893.
Regarding claim 75, Demichele teaches an ulcerative colitis (UC) dietary composition (a nutritional composition for modulating or reducing inflammation in an individual in need; Abstract, [0005]).
It is noted the same definitions outlined above in claim 73 for “low content,” any value less than 7.5%, and “high content,” any value greater than 10%, also apply here to claim 75.
Demichele teaches the composition does not specifically teach the addition of (a) a low content of sulfur and taurine within the composition. It is noted that other ingredients added into the composition, e.g. protein that contains sulfur or taurine, may be added to the composition [0086-0089]. Therefore, sulfur and taurine are being view as being in the composition either at 0% or having only a low content within the composition. This is within the low content range of less than 7.5%.
Demichele teaches the composition comprises low content of heme animal-based protein (protein source from animal meat; [0089]). Demichele discloses the total concentration of protein is in the composition ranging from about 0.25% to about 55% [0087-0088], which overlaps the amount considered to be “low content” of less than 7.5%. See MPEP 2144.05(I). It is noted that while Demichele recognizes animal meat as a protein source it does not require animal meat to be the protein source [0089]. Thus, Demichele discloses a low content of heme animal-based protein, or in other words 0% heme animal-based protein (animal meat; [0089]), which is within the claimed range of 0-7.5%, as required by claim 73, and smaller than 2.5%, as required by claim 74.
Demichele does not specifically teach animal-saturated fat within the composition as a type of fat that can be used [0093]. Therefore, the composition is considered to contain 0% animal-saturated fat, which is considered as being low content animal-saturated fat.
Regarding the recitation “food-stabilizers,” it is noted that food-stabilizers are being construed as an ingredient used to maintain or improve consistency, texture, and overall quality, such as xanthan gum.
Demichele teaches low content of food-stabilizers, where the food-stabilizers xanthan gum is added to the composition as part of a combination of carbohydrates and can be in an amount of about 5% or less, which is considered low content [0097-0098]. It is noted that while Demichele recognizes food-stabilizers, such as xanthan gum, as a carbohydrate source, it does not require xanthan gum to be the carbohydrate source [0098]. Thus, Demichele discloses a low content of food-stabilizers, or in other words 0% food stabilizers (xanthan gum; [0098]), which is within the claimed range of 0-7.5%.
Demichele teaches low content of maltodextrin, where the maltodextrin is added to the composition as part of a combination of carbohydrates and can be in an amount of about 5%, which is considered low content [0097-0098]. It is noted that while Demichele recognizes maltodextrin as a carbohydrate source, it does not require maltodextrin to be the carbohydrate source [0098]. Thus, Demichele discloses a low content of maltodextrin, or in other words 0% maltodextrin [0098], which is within the claimed range of 0-7.5%.
Demichele teaches low content of emulsifiers (emulsifying agents), where the emulsifier is an optional ingredient that may or may not be present in the composition and may be present at 0%, which is considered low content [0100].
Demichele discloses the composition comprises (b) a high content of fiber (carbohydrate including dietary fibers [0096-0098]). Demichele teaches the carbohydrate is present in an amount from about 5-65% [0097-0098], which overlaps the amount considered to be “high content” of greater than 10%. See MPEP 2144.05(I).
Demichele does not specifically note the presence of tryptophan within the composition. However, Demichele teaches the composition comprises protein and additional protein sources which are derived from any known or otherwise suitable sources [0089].
Langford teaches a nutritional formulation for the treatment of inflammatory conditions of the gastrointestinal tract (Abstract, [0001]), wherein the formula comprises a protein source [0013]. Langford teaches the protein source can be a mixture of whole proteins such as whey protein, soy protein and free amino acids, where the free amino acids include tryptophan [0028-0031]. It is noted that Langford does not limit the of amount free amino acids in the nutritional formulation compared to the amount of whole protein and even allows for all of the protein source to be wholly comprised of free amino acids [0027], [0030-0031]. Additionally, Langford also does not limit how much of a single free amino acid may be present in the formulation as long as the required amino acids are present ([0031], claims 9-10). Langford discloses the formulation comprises 12-18% by weight of the protein source [0036]. Thus, it can be envisaged that the tryptophan free amino acid source can be present in the formulation by at least greater than 10% to about 17% by weight and still have the addition of the other required amino acids. This is within the amount considered to be “high content” of greater than 10%. See MPEP 2144.05(I). Langford teaches that a formulation with tryptophan [0030-0031] can treat inflammatory conditions of the gastrointestinal tract [0001].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Demichele by incorporating the teachings of Langford by having tryptophan within the claimed range because this can help treat inflammatory conditions of the gastrointestinal tract, as taught by Langford [0001].
Demichele discloses (c) a total protein component (at least one additional source of protein; [0086]).
Regarding claim 76, Demichele teaches at least a portion of said fiber is pectin (the composition can have a combination of carbohydrates where a portion of the carbohydrates comes from pectin; [0097-0098]).
Demichele is silent as to the type of pectin within the composition. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Demichele to use any type of pectin, including apple pectin. See MPEP 2144.08.
Demichele teaches at least a portion of the total protein component is selected from whey protein, soy protein or mixtures thereof [0089].
Regarding claim 77, the limitation “wherein the total protein component is present in an amount formulated to provide a daily protein intake below 1 gr per kg of body weight for a patient consuming the composition” is directed toward the intended use of the composition and doesn’t further limit the claim. Thus, by meeting the protein limitation in claim 75, the limitation in claim 77 is met.
Regarding claim 78, Demichele teaches an additional protein not from animal origin (additional proteins from cereal (e.g., rice, corn), vegetable (e.g., soy, pea), such as soy protein; [0089]).
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive.
Applicant states, on pgs. 10-11 of their remarks, that Demichele fails to teach or suggest the claimed multi-faceted composition and that the rejection impermissibly relied on hindsight reconstruction. Applicant contends the invention is not merely a recipe but a carefully balanced, multi-faceted therapeutic composition designed to address the complex pathophysiology of Ulcerative Colitis (UC). Applicant asserts that Demichele is narrowly focused on a single active ingredient of rice protein hydrolysate and the rejection pieces together the claimed invention by selectively picking and choosing disparate elements from Demichele’s extensive and non-preferential list of ingredients. Applicant gives the example of Demichele’s protein range of 0.25% to 55% and how this renders a “low content” of protein obvious. Applicant states Demichele provides no motivation to select a protein level at the extreme low end of this range, but the instant specification gives rationale for a low protein diet. Applicant contends Demichele gives lists of possible ingredients but offers no teaching or motivation to combine them as outline in the claims. The Office disagrees for the following reasons.
As shown by the rejection above, the claimed invention is obvious over Demichele which teaches or suggests every limitation of the claimed invention as outlined in claim 73. The composition of Demichele is formulated to reduce inflammation and prevent and/or treat inflammatory conditions and diseases. It is noted that ulcerative colitis is a chronic inflammatory condition. The ingredients and ingredient amounts listed in different embodiments of Demichele, are done so with the goal to reduce inflammation in an individual. Regarding the amount of protein specifically, Demichele does teach protein within the claimed range and recognizes that the protein may be as low as 0.25% [0087]. Thus, showing that protein at this amount will help reduce inflammation. It is noted 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).
Additionally, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a low-protein diet is required to prevent the suppression of beneficial Faecalibacterium prausnitzii, prevent an increase in harmful sulfur-reducing bacteria, and reduce goblet cell damage) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues, on pg. 11, that Demichele teaches away from key aspects of the claimed invention. Applicant asserts Demichele explicitly teaches the inclusion of food stabilizers like pectin and xanthan gum and carbohydrates like maltodextrin as potentially significant components. Applicant contends these ingredients in the invention must be kept at a low content to be effective in treating UC. Applicant states that a person of ordinary skill reading Demichele would be taught to include these ingredients and not to strictly limit them. The Office disagrees for the following reasons.
As shown in claim 92 and the rejection above, the invention does teach these ingredients and Demichele also does teach these ingredients. Demichele teaches the composition includes a combination of carbohydrates including sucrose, maltodextrin, and pectin, where the total combination can be present in an amount from about 5% to about 65%, or about 5 grams to 65 grams per 100 ml of composition [0096-0097]. Therefore, it would have been obvious to a person of ordinary skill in the art to envisage the claimed amount and combination of carbohydrates where 11 grams per 100 ml of composition comes from sucrose and maltodextrin, and 1 gram per 100 ml of composition comes from pectin, since this would give a total amount of carbohydrates of about 12%, or 12 grams per 100 ml of composition, which is an amount within the disclosed range and with disclosed ingredients of Demichele. Thus, Demichele does teach keeping these ingredients at a low amount.
Moreover, a prior art reference that "teaches away" from the claimed invention is a significant factor to be considered in determining obviousness; however, "the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) MPEP 2145(X)(D)(1).
Applicant teaches, on pg. 12, that the present specification provides clinical evidence of unexpected results, which provide powerful objective evidence of non-obviousness. Applicant states that the claimed dietary approach induced a 73% response rate and 40% remission rate at week 6 in a pilot trail of pediatric UC patients. Applicant notes that an ongoing trial of adults showed 40% clinical remission at 8 weeks. Applicant contends Demichele provides no clinical data for UC, relying solely on in-vitro cell culture and mouse models of general inflammation. Applicant asserts the objective evidence of non-obviousness strongly rebuts the prima facie case of obviousness. The Office disagrees for the following reasons.
On pgs. 23-24 of the applicant’s specification, it discusses the pilot trial and ongoing trial of a formula used as a supplement to the diet for treatment of UC. It is noted that this “formula” mentioned on pg. 24, is being construed as the formula presented in Table 1 on pg. 26 of the specification. However, Applicant has not shown any evidence that the unexpected results occur over the entirety of the claimed ranges. Claim 73 has a broad range of the high content ingredient, only requiring any value greater than 10% of at least one ingredient from the group consisting of fiber and tryptophan. Claim 73 also only requires a low content of between 0-7.5% of a list of other ingredients, that may or may not be in the formula since they can be present at 0%. The formula shown on pg. 26 only shows one data point for the high content ingredient of fiber and does not even include tryptophan at a high content, or at least data is not given to show that tryptophan from the whey protein is at a high content. Applicant also only gives one data point for any low content ingredients present. Since applicant only shows evidence of one formulation that shows only one data point, Applicant does not provide an adequate basis for concluding that similar results would be obtained within the scope of the generic broad ranges claimed in claim 73. Thus, the results obtained by the formulation in Table 1 are not commensurate in scope with the claimed invention. See MPEP 716.02(d).
Applicant argues, on pgs. 12-13, that claim 75 has been amended to recite a very specific and deliberate combination of low content ingredients, while also having a high content of fiber and a high content of tryptophan. Applicant states that Demichele provides no motivation to create a composition with this precise profile and the combination with Banaszek fails to cure this deficiency. Applicant argues that there is no motivation to formulate a composition with a high content of tryptophan for the purpose of treating UC and that neither Demichele nor Banaszek contemplate formulating a diet with intentionally high levels of tryptophan for this specific therapeutic purpose.
Applicant’s arguments with respect to claim(s) 75-78 and the high content of tryptophan have been considered but are moot because the new ground of rejection does not rely on any teaching or matter specifically challenged in the argument.
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.
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759