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’s response filed on July 10, 2026, has been fully considered.
All previous claim rejections of the Office action dated January 13, 2026, have been withdrawn in view of the amendment.
New rejections have been made to address the amended claims.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 10, and September 9, 2026, was filed after the mailing date of the Non-Final Rejection on January 13, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 19- 25, 27, 28, 31-32, 34, 36, 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Bolis Tube Feeding with Puree Pouches and the Bolink Small Cap (https://www.youtube.com/shorts/2E8FPubjKZQ, published July 29, 2018) (“Bolink” hereunder) in view of Laver et al. (US 10806169 B, published on October 20, 2020) (“Laver” hereunder).
Claim 19 is representative of the present invention and directed to a bag system comprising a nutritional composition, comprising:
a pouch comprising a first side panel comprising a first side edge, a second side edge, a top edge, and a bottom edge,
a second side panel comprising a first side edge, a second side edge, a top edge, and a bottom edge, and a bottom panel,
wherein (i) the first side edge of the first side panel is fused with the first side edge of the second side panel,
(ii) the second side edge of the first side panel is fused with the second side edge of the second side panel,
(iii) the top edge of the first panel is fused with the top edge of the second panel, and
(iv) the bottom edge of the first side panel, the bottom edge of the second side panel,
and the bottom panel are fused together, thereby forming a chamber for containing the nutritional composition;
the nutritional composition, wherein the nutritional composition comprises fatty acids, dietary fibers, carbohydrates, a vitamin and mineral blend, proteins, and a whole food blend; and
a spout located on the pouch, wherein the spout is configured to eject the nutritional composition from the pouch,
wherein the spout is suitable for oral feeding and tube feeding of the nutritional composition.
The Bolink Youtube Short features a commercially purchased puree pouch for oral consumption and an adopter and connector which screws directly onto the spout of the pouch and converts the standard oral spout into a secure tube feeding connection. The store-bought puree pouch meets the limitations of the present pouch.
The video fails to teach the specific contents of the enteral liquid food.
Laver teaches a nutrient composition in liquid form for enteral and/or oral feeding, the composition is entirely plant-based and free of allergens or synthetic ingredients and contains optimal nutrients to users. See abstract. The composition comprises pea protein hydrolysate and fatty acid-containing components. The reference further teaches that organic brown rice syrup solid, a carbohydrate, is used as a sugar substitute. See col. 16, lines 30 – 61. The reference further teaches adding one or more vitamins and mineral blend. See col. 3, lines 21-25.
Given the teachings of enteral administration of pureed food, one of ordinary skill in the art before the effective fling date of the present application would have been obviously motivated to look to prior arts such as Laver for specific enteral feeding formulas. Since Laver’s tube feeding formula is free of common allergens and synthetic ingredients, the skilled artisan would have been obviously motivated to combine the references with a reasonable expectation of successfully producing a pureed food for safely delivering patient’s complete nutritional requirements with reduced risk of adverse reactions. See present claims 19, 21, 23, 24, 27, 28, 31, 32 and 39.
Regarding claim 20, as Laver teaches that the environment where food is handled and sealed is maintained sterile, sterilizing the pouch which store the food would have been obvious.. See col. 21, lines 7 – 13.
Claim 22 recites, “the spout is for filling and dispensing the nutritional composition for feeding”. The term “for filing” is the intended use and future purpose and is a preamble. There is nothing in the reference to indicate that the same spout is not suitable and capable for filling the bag.
Claim 25, Laver does not teach or suggest that the disclosed enteral food requires dilution or alteration for tube feeding, and the nutritional composition is viewed a ready-to-eat formulation.
Claims 27 and 28, Laver teaches that the food is sourced from organic plants, non-GMO, and free of milk, wheat, soy, eggs, peanuts, tree nuts, fish, shellfish, or corn. The disclosed formulations do not mention sesame seed is used in the formulation. See col. 21, lines 13-22.
Regarding claim 31, the Bolink YouTube shorts demonstrates that the puree pouch is squeezable.
Regarding claim 34, Laver teaches adding a vitamin and mineral blend, which can include sodium ascorbate, beta carotene, vitamin A palmitate, thiamine hydrochloride, sodium selenite, vitamin B 12, etc. See col. 3, lines 26 – 38.
Regarding claim 36, Laver teaches that the fatty acid in the enteral formula contains a blend of essential omega-6 and omega-3 fatty acids. See p. 14, line 22 -40.
Regarding claim 37, Laver teaches that the hydrolyzed pea protein used in the formula ”delivers a full amino acid profile” to the patient or user with a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 98%. See col. 5, lines 38 – 53.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Bolink and Laver as applied to claims 19- 25, 27, 28, 31-32, 34, 36, 37 and 39 as above, and further in view of Clegg et al. (US 5057093 A, published on October 15, 1991) (“Clegg” hereunder) and Administration Guidelines – Functional Formularies (December 10, 2021, www.functionalormularies.com, cited in IDS) (“Administration Guidelines” hereunder).
Regarding claim 26, Clegg teaches a universal adopter which enables use with connectors of various sizes of tube. See abstract. Administration Guidelines teaches that nasogastric tubes (NG) have sizes of 8 French Tubes and larger. It would have been obvious to one of ordinary skill in the art to use nasogastric rubes having such conventional sizes for safe enteral administration.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Bolink and Laver as applied to claims 19- 25, 27, 28, 31-32, 34, 36, 37 and 39 as above, and further in view of Kawashima et al. (US 20140087055 A1, published on March 27, 2014) (“Kawashima” hereunder).
Regarding claim 29, although Laver does not specifically disclose the viscosity of the enteral food composition, the composition must have a sufficiently flowable viscosity.
For example, Kawashima teaches that tube-feeding enteral nutrients preferably have 250-1000 cps. See [0096].
Given the teachings of the enteral liquid food in Laver, one of ordinary skill in the art before the effective filing date of the present application to look to prior arts such as Kawashima for suitable viscosity of the disclosed formula to successfully make a flowable food composition suitable for tube-feeding.
Claims 30, 33-35 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Bolink and Laver as applied to claims 19- 25, 27, 28, 31-32, 36, 37 and 39 as above, and further in view of Galperin et al. (SU 1479055 A1, published on May 15, 1989) (“Galperin” hereunder), Tian et al. (CN 110584093 A, published on August 1, 2019) (“Tian” hereunder) and Patentin et al. (DE 102020105009 A1, published on August 26, 2021) (“Patentin” hereunder).
Laver teaches that the enteral formula contains organic hydrolyzed pea protein, high linoleic sunflower oil, flax seed oil, medium chain triglycerides, flours from milled chia and quinoa and phytochemical extracts from fruits, vegetables, herbs and spices. Regarding claim 30, Laver suggests that the disclosed formula contains a targeted selection of nutritional ingredients that can be used as a sole source or supplemental source of nutrition for pediatric patients. See col. 2, lines 44 -49.
Laver fails to teach “blenderized” food as described in claim 30 and the oat/buckwheat flour and fruit/vegetable purees in claim 33.
Galperin teaches an enteral formula for tube feeding, comprising oat flour, sunflower oil, applesauce, cooked and mashed potato, etc., in water. The reference teaches that the nutrient mixture is heated and homogenized, which suggests that blenderized food for enteral formula is old and well known. See translation, abstract; See present claim 30.
Tian teaches an enteral formula for tube feeding, the composition comprising buckwheat flour.
Patentin teaches that chia flour, quinoa flour, oat flour and buckwheat flour are gluten-free and suitable for people with different food allergies and intolerances. See translation, Abstract and Advantage.
It is well settled in patent law that substituting art-recognized functional equivalents for same purposes is prima facie obvious. See MPEP 2144.06. Patentin establishes that the chia and quinoa flours used in Laver and oat/buckwheat flours are all gluten-free grain flours which are suitable for people with gluten allergies and intolerance; Laver, Tian and Galperin establish that the said flours are also all suitable in formulating enteral feeding compositions. It follows that substituting one gluten-free grain flour suitable for enteral tube feeding for the other for the same purpose of making enteral tube feeding formula would have been prima facie obvious before the effective filing date of the present application.
While Laver teaches using prebiotic fibers and phytochemical extracts from fruits and vegetable, Galperin teaches that fruit and vegetable purees such as applesauce and mashed potato are used in an enteral formula. The latter teaches that the goal of the invention is to provide a mixture of natural products with balanced electrolytes suitable for intraintestinal administration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Laver and substitute the phytochemical extracts from fruits and vegetable with pureed fruits and vegetable as motivated by Galperin, as the latter teaches that natural products in pureed form can be suitable for tube feeding.
Regarding claim 38, Laver discloses a formula comprising i) purified water in the maximum about of 68.5 wt %; ii) organic hydrolyzed pea protein 6-9.2 %; iii) organic high linoleic sunflower oil 2.5 – 3 %; iv) organic flax seed oil 1.1-1.5 %, organic medium chain triglycerides 2.3-2.8 %. The only difference between the composition of the present invention and Laver composition is that the latter contains a higher amount of hydrolyzed pea protein. The lower bound of the prior art range is 6 wt %, whereas the upper bound of the pea protein in the present invention is 4.1 wt %. Since the scope of the nutritional composition in claim 38 is open to include other components not recited in the claims, protein can be supplemented from other ingredients, such as oat flour, which also provides protein. See Galperin, abstract. Thus, in adding oat flour in the Laver formula, one of ordinary skill in the art would have been obviously motivated to reduce the amount of the pea protein in order to maintain the nutrition balance of the modified composition.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 19, 21-25, 27, 28, 31, 32, 34, 36, 37 and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10806169 in view of Bolink.
The reference claim 1 discloses a nutrient composition in liquid form for enteral and/or oral feeding, the composition comprising: pea protein hydrolysate, phytochemical extracts, fatty acid-containing components, one or more organic ingredients, and one or more prebiotic fibers. The reference claim 8 further teaches that the composition further comprises one or more vitamin and mineral blend.
Although the claims do not disclose a bag system containing the said nutrient composition, a bag systems comprising a chamber or pouch for containing a liquid food and a port or spout for filling and/or attaching a tube for dispensing the food are well known. The Bolink Youtube Short features a commercially purchased puree pouch for oral consumption and an adopter and connector which screws directly onto the spout of the pouch and converts the standard oral spout into a secure tube feeding connection. The store-bought puree pouch meets the limitations of the present pouch.
Given the teaching of the liquid nutrient composition for oral and enteral feeding, one of ordinary skill in the art would have been obviously motivated to look to prior arts such as Bolink for teachings on using a conveniently available bag system suitable for both routes of feeding methods. Since Bolink teaches that using the adopter can easily convert the oral feeding spout to tube feeding dispenser, the skilled artisan would have been motivated to use such adopter with a conventional puree pouch to store the oral/enteral food and dispense the food for the patient as needed. See present claims 19, 21, 23, 24, 31, 32 and 39.
Claim 22 recites, “the spout is for filling and dispensing the nutritional composition for feeding”. The term “for filing” is the intended use and future purpose and is a preamble.
Regarding the present claim 25, the ‘169 claims do not teach or suggest that the disclosed enteral food requires dilution or alteration for tube feeding, and the nutritional composition is viewed a ready-to-eat formulation.
Regarding the present claims 27 and 28, the disclosed formulations in the ‘169 claims are free of milk, wheat, soy, eggs, peanuts, tree nuts, fish, shellfish, corn or sesame; the claims indicated that organic ingredients are used, which suggest that the ingredients in the enteral formula are free of pesticides, herbicides, etc.
Regarding claim 34, the reference claims 8-10 teaches adding a vitamin and mineral blend, which can include sodium ascorbate, beta carotene, vitamin A palmitate, thiamine hydrochloride, sodium selenite, vitamin B 12, etc.
Regarding claim 36, the term “fatty acid” in reference claim 1 is defined to include a blend of essential omega-6 and omega-3 fatty acids. See p. 14, line 22 -40.
Regarding claim 37, the term “ hydrolyzed pea protein” in reference claims is defined to provide “a full amino acid profile” to the patient or user with a Protein Digestibility Corrected Amino Acid Score (PDCAAS) of 98%. See col. 5, lines 38 – 53.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. and Bolink as applied to claims 19, 21-25, 27, 28, 31, 32, 34, 36, 37 and 39 as above, and further in view of Takada (WO 2004108545 A1, published on Dec 16, 2004).
Although Bolink does not specifically teach sterilized bags, such would have been obvious as Takada teaches various sterilization techniques are performed during preparing feeding bags. See translation, p. 11, first full paragraph.
Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10806169 and Bolink as applied to claims 19, 21-25, 27, 28, 31, 32, 34, 36, 37 and 39 as above, and further in view of Clegg and Administration Guidelines.
Regarding claim 26, Clegg teaches a universal adopter which enables use with connectors of various sizes of tube. See abstract. Administration Guidelines teaches that nasogastric tubes (NG) have sizes of 8 French Tubes and larger. It would have been obvious to one of ordinary skill in the art to use nasogastric rubes having such conventional sizes for safe enteral administration.
Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10806169 and Bolink as applied to claims 19, 21-25, 27, 28, 31, 32, 34, 36, 37 and 39 as above, and further in view of Kawashima.
Regarding claim 29, although the patented claims do not disclose the specific viscosity of the composition, it would have been obvious to one of ordinary skill in the art that the enteral formula must have a viscosity suitable for tube feeding.
For example, Kawashima teaches that tube-feeding enteral nutrients preferably have 250-1000 cps. See [0096].
Given the teachings of the enteral liquid food in the ‘169 claims, one of ordinary skill in the art before the effective filing date of the present application to look to prior arts such as Kawashima for suitable viscosity of the disclosed formula to successfully make a flowable food composition suitable for tube-feeding.
Claims 30, 33-35 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10806169 and Bolink as applied to claims 19, 21-25, 27, 28, 31, 32, 34, 36, 37 and 39 as above, and further in view of Galperin, Tian and Patentin.
The reference claims 1 and 13 teach that the enteral formula contains organic hydrolyzed pea protein, high linoleic sunflower oil, flax seed oil, medium chain triglycerides, flours from milled chia and quinoa and phytochemical extracts from fruits, vegetables, herbs and spices. Regarding claim 30, the disclosed enteric formula suggests that such balanced nutrition profile can be used as a sole source or supplemental source of nutrition for patients.
The ‘169 claims fail to teach “blenderized” food as described in claim 30 and the oat/buckwheat flour and fruit/vegetable purees in claim 33.
Galperin teaches an enteral formula for tube feeding, comprising oat flour, sunflower oil, applesauce, cooked and mashed potato, etc., in water. The reference teaches that the nutrient mixture is heated and homogenized, which suggests that blenderized food for enteral formula is old and well known. See translation, abstract; See present claim 30.
Tian teaches an enteral formula for tube feeding, the composition comprising buckwheat flour.
Patentin teaches that chia flour, quinoa flour, oat flour and buckwheat flour are gluten-free and suitable for people with different food allergies and intolerances. See translation, Abstract and Advantage.
It is well settled in patent law that substituting art-recognized functional equivalents for same purposes is prima facie obvious. See MPEP 2144.06. Patentin establishes that the chia and quinoa flours used in the ‘169 claims and oat/buckwheat flours are all gluten-free grain flours which are suitable for people with gluten allergies and intolerance; the ‘169 claims, Tian and Galperin establish that the said flours are also all suitable in formulating enteral feeding compositions. It follows that substituting one gluten-free grain flour suitable for enteral tube feeding for the other for the same purpose of making enteral tube feeding formula would have been prima facie obvious before the effective filing date of the present application.
While the ‘169 claims teach using prebiotic fibers and phytochemical extracts from fruits and vegetable, Galperin teaches that fruit and vegetable purees such as applesauce and mashed potato are used in an enteral formula. The latter teaches that the goal of the invention is to provide a mixture of natural products with balanced electrolytes suitable for intraintestinal administration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of the ‘169 claims and substitute the phytochemical extracts from fruits and vegetable with pureed fruits and vegetable as motivated by Galperin, as the latter teaches that natural products in pureed form can be suitable for tube feeding.
Regarding claim 38, the reference claims 1-10 discloses a formula comprising i) purified water in the maximum about of 68 – 69.55 wt %; ii) organic hydrolyzed pea protein 6-9.2 %; iii) organic high linoleic sunflower oil 2.5 – 3.5 %; iv) organic flax seed oil 1.1-1.5 %, organic medium chain triglycerides 2.3-2.8 %. The only difference between the composition of the present invention and the patented formulation is that the latter contains a higher amount of hydrolyzed pea protein: The lower bound of the prior art range is 6 wt %, whereas the upper bound of the pea protein in the present invention is 4.1 wt %. Since the scope of the nutritional composition in claim 38 is open to include other components not recited in the claims, protein can be supplemented from other ingredients, such as oat flour, which also provides protein. See Galperin, abstract. Thus, in adding oat flour in the ‘169 formula, one of ordinary skill in the art would have been obviously motivated to reduce the amount of the pea protein in order to maintain the nutrition balance of the modified composition.
Response to Arguments
Applicant’s arguments filed on July 10, 2026, have been considered but are moot in view of the new grounds of rejections.
Conclusion
No claims are allowed.
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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/GINA C JUSTICE/ Primary Examiner, Art Unit 1617
