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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/03/2026 has been entered.
Status of Claims
Claims 73-74 and 79-92 are pending in this application. Claims 73-74, 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 Claims 80-89 are withdrawn. Any objections or rejections not repeated below have been withdrawn.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 § 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.
Claims 91-92 are rejected 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.
Claim 91 recites, “comprising apple pectin.” Claim 73, from which claim 91 depends, recites, “An ulcerative colitis (UC) dietary composition comprising… (b) fiber comprising pectin.” It is unclear if the “apple pectin” recited in claim 91 is in addition to the “pectin” recited in claim 73, or if the pectin of claim 73 is being further limited to “apple pectin” in claim 91 and is the same pectin recited in claim 73. For the purpose of examination, the “apple pectin” of claim 91 will be considered the same pectin recited in claim 73, where the pectin is being further limited to “apple pectin.”
Claim 92 recites, “comprising… 1 gram apple pectin.” Claim 73, from which claim 92 depends, recites, “An ulcerative colitis (UC) dietary composition comprising… (b) fiber comprising pectin.” It is unclear if the “apple pectin” recited in claim 92 is in addition to the “pectin” recited in claim 73, or if the pectin of claim 73 is being further limited to “apple pectin” in claim 92 and is the same pectin recited in claim 73. For the purpose of examination, the “apple pectin” of claim 92 will be considered the same pectin recited in claim 73, where the pectin is being further limited to “apple pectin.”
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 between 0-7.5% unless otherwise defined by the claim.
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 smaller than 2.5%, as required by claim 73, or smaller than about 0.5%, as required by claim 74.
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 low content range of smaller than 2.5%, as required by claim 73, or smaller than about 0.5%, as required by claim 74. See MPEP 2144.05(I).
Alternatively, 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 smaller than 2.5%, as required by claim 73, or smaller than about 0.5%, 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 and within the low content range of smaller than 2.5%, as required by claim 73, or within the range of smaller than about 0.5%, as required by claim 74.
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 may be added to the composition as part of a combination of carbohydrates [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 claim 73 range of smaller than 2.5%, and within the claim 74 range of smaller than about 0.5%.
Demichele recognizes maltodextrin as a carbohydrate source but does not require maltodextrin to be the carbohydrate source [0098]. Demichele discloses a low content of maltodextrin, where the maltodextrin may be added to the composition as part of a combination of carbohydrates [0097-0098]. Thus, it would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Demichele to include none or a small amount of maltodextrin within the claim 73 or claim 74 “low content” range, because it is an optional ingredient, that may or may not be present in the composition as part of a combination of carbohydrates [0097-0098].
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% [0100], which is considered low content and within the claim 73 range of smaller than 2.5%, and within the claim 74 range of smaller than about 0.5%.
Demichele discloses the composition comprises (b) fiber (carbohydrate including dietary fibers), where 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]), as required by claim 73.
Demichele teaches (c) a protein component (at least one additional source of protein; [0086]) selected from the group consisting of whey protein, soy protein or mixtures thereof [0089], as required by claim 73.
Regarding limitation (d) “wherein the total amount of protein provides a daily protein intake below about 1 gram per kg of body weight,” this limitation is directed toward the intended use of the composition and doesn’t further limit the claim. Thus, by meeting the protein limitation above for claim 73, this additional limitation in claim 73 is met.
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, which 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 have provided these components of pectin, sucrose and maltodextrin in amounts as claimed as the claimed amounts fall within ranges taught by the prior art [0096-0097]. 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 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]).
Response to Arguments
Applicant's arguments filed 08/03/2026 have been fully considered but they are not persuasive.
Applicant argues, on pg. 8 of their remarks, that Demichele is not directed to an ulcerative colitis (UC) dietary composition. Applicant contends that the protein source for the claimed invention is selected from whey, goat-milk-whey, or soy protein at a low amount, while Demichele uses rice protein hydrolysate as their preferred protein. Applicant selects whey or soy protein because this protein is rich in tryptophan and elevated tryptophan supports mucus production and mucosal healing in UC. Applicant argues that Demichele does not teach restricting protein overall while also selecting a protein source that is comparatively rich in tryptophan. Applicant states that Demichele does not teach or suggest a UC composition that (i) uses a protein component selected from whey, soy, or goat-milk whey protein to the exclusion of rice protein hydrolysate, (ii) provides that protein at a low amount, (iii) simultaneously restricts low content ingredients, (iv) supplies fiber comprising pectin. 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).
In response to applicant's argument that the reference fails to show certain features of the invention, it is noted that the feature upon which applicant relies (i.e., excluding rice protein hydrolysate) is not recited in the rejected claim(s). Applicant also argues that Demichele does not teach selecting a protein source that is comparatively rich in tryptophan while protein overall is restricted. However, as shown by the above rejection, Demichele does teach the claimed protein source of whey protein, soy protein or mixtures thereof within the claimed amount [0087-0089], which the applicant views as being rich in tryptophan. Demichele also teaches low content ingredients and supplies fiber comprising pectin (the composition can have a combination of carbohydrates where a portion of the carbohydrates comes from pectin; [0097-0098]), see above rejection for claim 73. Thus, as shown by the rejection above, the composition recited in claim 73 is rendered obvious by Demichele.
Applicant argues, on pg. 9, that Demichele requires a rice protein hydrolysate of a defined degree of hydrolysis and peptide-size distribution as the operative active ingredient, while the inclusion of other proteins are only recited in addition to the rice protein hydrolysate. Applicant contends that amended claim 73 part (c) excludes rice protein hydrolysate and that Demichele teaches away from the claimed protein component. Applicant continues, stating that a person of ordinary skill would have been motivated in a different direction from the claimed invention to include a rice protein hydrolysate as the operative anti-inflammatory active, to include a low-DE maltodextrin, and to select fats from an undifferentiated list of oils. The Office disagrees for the following reasons.
Claim 73 part (c) does require that the composition comprises a protein where the protein is selected from the group consisting of whey protein, soy protein, goat-milk whey protein, and a mixture thereof. However, the composition does not exclude rice protein hydrolysate. Rice protein can still be in the composition, as the composition does not exclude other proteins but only requires that a protein from the group listed in part (c) also be present as an ingredient in the composition.
Demichele does not teach away from the claimed composition and does not fail to disclose the composition. As discussed above, while Demichele does require rice protein hydrolysate, it also includes the claimed proteins. Regarding maltodextrin and the selection of fats, Demichele recognizes maltodextrin as a carbohydrate source but does not require maltodextrin to be the carbohydrate source [0098]. Demichele discloses a low content of maltodextrin, where the maltodextrin may be added to the composition as part of a combination of carbohydrates [0097-0098]. Thus, it would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Demichele to include none or a small amount of maltodextrin within the claim 73 or claim 74 “low content” range, because it is an optional ingredient, that may or may not be present in the composition as part of a combination of carbohydrates [0097-0098]. 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]. Thus, Demichele does not teach away from the claimed invention but rather a person of ordinary skill in the art would have been motivated to produce a composition that is substantially identical to the claimed composition.
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 argues, on pgs. 9-10, that Demichele does not address ulcerative colitis, Faecalibacterium prausnitzii, or the restriction of sulfur and taurine, and therefore supplies no motivation for the claimed UC-specific low-content profile. Additionally, applicant contends that claim 73 part (d) is a substantive, limiting feature, not a mere statement of intended use. Applicant explains that the specification establishes that maintaining protein at this low level is a functional requirement of the invention. Applicant states that because limitation (d) gives meaning and purpose to, and constrains the claimed composition, it is entitled to patentable weight. However, the Office disagrees for the following reasons.
The required ingredients have been identified in the rejection, satisfying the claimed limitations. Even though Demichele does not specifically recite that ulcerative colitis is being treated or outline the specific amount of composition that should be consumed per day based on a person’s body weight, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Thus, if the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that Demichele does not address ulcerative colitis, Faecalibacterium prausnitzii, or the restriction of sulfur and taurine, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Additionally, regarding recitation (d), the claims are directed towards a composition and not a method of using a composition. Thus, this limitation is still considered as being directed toward the intended use of the composition and doesn’t further limit the claim. Therefore, by meeting the protein limitation above for claim 73, limitation (d) in claim 73 is met.
Applicant argues, on pg. 10, that Demichele Example 2 uses canola oil and a second oil, but the second oil in the example is not MCT oil. Applicant contends that Demichele does not teach or suggest canola oil in combination with MCT oil within the claimed ranges. Demichele only lists MCT oil within an undifferentiated list of approximately fifteen fats. However, the Office disagrees for the following reasons.
While Demichele does disclose multiple oils that can be used in the composition, as stated in MPEP 2123, “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).” Thus, it is reasonable for a person of ordinary skill to have selected canola oil in combination with MCT oil, since it is taught in the prior art.
Additionally, as stated in the rejection 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
Applicant’s arguments with respect to Langford, on pgs. 10-11, have been considered but are moot. The Langford reference was used in the rejection for claims 75-78, which claims have since been cancelled.
Applicant states, on pg. 11, that the composition of claim 92 reads on the formulation of Table 1, which formulation was used in the Applicant’s clinical studies. Applicant states that the clinical trial found a 73% clinical response when using the composition and a 40% remission rate at week 6 in a pediatric ulcerative colitis pilot, and 40% clinical remission at week 8 in adults refractory to medication. Applicant contends that because this claim is tied to the tested composition, the unexpected clinical results are commensurate in scope with the claims. However, the Office disagrees for the following reasons.
The formulation on pg. 26 in Table 1 of the instant specification is viewed as being commensurate in scope with claim 92. However, this does not necessarily establish that the claimed composition has unexpected results when compared to Demichele. MPEP 716.02 states, “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).”
To show whether the properties of the claimed composition differ to such an extent that the difference is really unexpected, a comparison with the closest prior art is needed. MPEP 716.02(e) explains an affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). "A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960). The applicant has not compared the closest prior art, specifically the composition of Demichele, to the claimed product. Thus, the above rejection does establish a prima facie case of obviousness for amended claim 73 and for dependent claims 74, 79 and 90-92.
Conclusion
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
