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 .
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.
Claim 33 is 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 33 recites “dietary fibers from . . .pea protein and the carbohydrates comprise . . . pea protein”. Such limitation is confusing because an isolated protein would not be normally considered a source of dietary fibers or carbohydrates. Consistent with the well-established axiom in patent law that a patentee or applicant is free to be his or her own lexicographer, a patentee or applicant may use terms in a manner contrary to or inconsistent with one or more of their ordinary meanings if the written description clearly redefines the terms. See 2173.05 (a), III. In this case, the specification provides no special definition of the terms “dietary fibers” and “carbohydrates” that would assign the terms meaning other than that understood by a person of ordinary skill in the art. Because the terms “dietary fiber” and “carbohydrates” are used inconsistently with their ordinary meaning in the art, a person of ordinary skill in the art would not be able to determine the metes and bounds of the scope of the terms.
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.
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.
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 19-23, 25, 27, 28, 31, 32, 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Takada et al. (WO 2004108545 A1, published on December 16, 2004) (“Takada” 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 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 bag system is suitable for oral feeding and tube feeding of the nutritional composition.
Takada teaches a bag for containing enteral nutrient, enteral liquid food or the like. See abstract. The bag is formed by sealing the circumferential part of a plurality of film pieces facing each other; meeting the requirements of the present claim 19, (i)-(iii). See original document, Fig. 1. The bag also has the bottom part 9 arranged between the bottom edges of the two film pieces which forms the bottom panel, which forms a chamber and meets the requirement of the present claim 19, (iv).
The Takada bag also comprises a spout member 5 attached to the packaging bag which is configure to eject and discharge the nutritional composition from the pouch. See Fig. 3. The reference teaches that the spout is for connecting a tube or the like to charge the contents to the outside, which indicates its use for tube feeding. See also Claims 21, 23 and 24.
The present claim 19 recites that the bag system is “suitable for oral feeding” which is a preamble and denotes an intended future use and purpose. See MPEP 2111. 02. Although Takada does not specifically mention using the spout for oral feeding, the spout member 5 of the bag system is suitable and capable of such use, as the spout is designed to eject and discharge the content.
Takada 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 comprising: 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 vitamin and mineral blend. See col. 3, lines 21-25.
Given the teachings of the Takada bag system for packaging enteral liquid 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 bag system for safely delivering patient’s complete nutritional requirements with reduced risk of adverse reactions.
Regarding claim 20, Takada teaches that various sterilization techniques are performed in preparing the bag system. See translation, p. 11, first full paragraph.
Regarding claims 21, 23 and 24, as discussed above, Takada teaches that the spout member 5 is used for connecting a tube or the like to discharge the contents to the outside.
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. Although Takada teaches that another spout member 4 is present in the packaging bag and the spout member 5 is used for dispensing, there is nothing in the reference to indicate that the same spout is not suitable and capable for filling the bag. Thus, the Takada bag also meets the present limitation. Furthermore, Takada in fact teaches that conventional bags for enteral feeding having only one spout is old and well known. See p. 2, bridging paragraph.
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, Takada teaches that the bag is made of resin films such as polyethylene or polypropylene resin, and the material constituting the liner may have a suitable cushioning property and flexibility, which suggests that the bag is squeezable. See translation, p.7, bridging paragraph.
Regarding claim 32, the spout member 5 has a cap for opening and closing the spout. See Takada, Fig. 3.
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.
Claims 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Takada and Laver as applied to claims 19-23, 25, 27, 28, 31, 32, 36 and 37as 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).
Takada teaches that the port member 5 is used to connect “a tube or the like to the spout to discharge the contents to the outside.” Using catheter to connect a bag holding liquid nutritional product and nasogastric feeding tube is old and well known. See Clegg, abstract. Connecting such device to the discharge port of the Takada bag system for tube feeding would have been an obvious use of the prior art enteral bag system. See present claim 24.
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 Takada and Laver as applied to claims 19-23, 25, 27, 28, 31, 32, 36 and 37 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 Takada and Laver as applied to claims 19-23, 25, 27, 28, 31, 32, 36 and 37 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 19-23, 25, 27, 28, 31, 32, 36 and 37 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 Takada.
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, enteral 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. For example, Takada teaches a bag for containing enteral nutrient, enteral liquid food or the like. See abstract. The bag is formed by sealing the circumferential part of a plurality of film pieces facing each other; meeting the requirements of the present claim 19, (i)-(iii). See original document, Fig. 1. The bag also has the bottom part 9 arranged between the bottom edges of the two film pieces which forms the bottom panel, which forms a chamber and meets the requirement of the present claim 19, (iv).
The Takada bag also comprises a spout member 5 attached to the packaging bag which is configure to eject and discharge the nutritional composition from the pouch. See Fig. 3. The reference teaches that the spout is for connecting a tube or the like to charge the contents to the outside, which indicates its use for tube feeding. See also
The present claim 19 recites that the bag system is “suitable for oral feeding” which is a preamble and denotes an intended future use and purpose. See MPEP 2111. 02. Although Takada does not specifically mention using the spout for oral feeding, the spout member 5 of the bag system is suitable and capable of such use, as the spout is designed to eject and discharge the content.
Given the teaching of the liquid nutrient composition for enteral feeding, one of ordinary skill in the art would have been obviously motivated to look to prior arts such as Takada for specific teachings on bag systems suitable for packaging and dispensing the food. Since the Takada bag system is specifically designed for handling enteral formulas, the skilled artisan would have had a reasonable expectation of successfully combining the references and making a bag system in which the patented enteral formula is safely stored and properly dispensed to patients in need thereof.
Regarding claim 20, Takada teaches that various sterilization techniques are performed in preparing the bag system. See translation, p. 11, first full paragraph.
Regarding claims 21, 23 and 24, as discussed above, Takada teaches that the spout member 5 is used for connecting a tube or the like to charge the contents to the outside..
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. Although Takada teaches that another spout member 4 is present in the packaging bag and the spout member 5 is used for dispensing, there is nothing in the reference to indicate that the same spout is not suitable and capable for filling the bag. Thus, the Takada bag also meets the present limitation. Furthermore, Takada in fact teaches that conventional bags for enteral feeding having only one spout is old and well known. See p. 2, bridging paragraph.
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 31, Takada teaches that the bag is made of resin films such as polyethylene or polypropylene resin, and the material constituting the liner may have a suitable cushioning property and flexibility, which suggests that the bag is squeezable. See translation, p.7, bridging paragraph.
Regarding claim 32, the spout 5 has have a cap for opening and closing the spout. See Takada, Fig. 3.
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, 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.
Claims 24 and 26 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 Takada as applied to claims 19-23, 25, 27, 28, 31, 32, 36 and 37 as above, and further in view of Clegg and Administration Guidelines.
Takada teaches that the port member 5 is used to connect “a tube or the like to the spout to discharge the contents to the outside.” Using catheter to connect a bag holding liquid nutritional product and nasogastric feeding tube is old and well known. See Clegg, abstract. Connecting such device to the discharge port of the Takada bag system for tube feeding would have been an obvious use of the prior art enteral bag system. See present claim 24.
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 in view of Takada as applied to claims 19-23, 25, 27, 28, 31, 32, 36 and 37 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 in view of Takada as applied to claims 19-23, 25, 27, 28, 31, 32, 36 and 37 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.
Conclusion
No claims are allowed.
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/GINA C JUSTICE/ Primary Examiner, Art Unit 1617