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 reply filed on November 20, 2025 has been fully considered.
The previous claim rejection made under 35 U.S.C. 112 (b) as indicated in the Office action dated May 20, 2025 is withdrawn in view of applicant’s remarks.
The previous claim rejection made under 35 U.S.C. 103 over Rahm et al. (US 20160287644 A1) in view of Lusinski (“11 Surprising uses for Epsom salt in and around your house”, www.simplemost.com) in view of Natural Epsom Salt (Amoray Care, October 2014), Brainard (US 20140044809 A1) and Langford (US 20120076914 A1) has been modified to address the new claim limitation made to claim 1 which requires the high efficacy probiotic comprises at least approximately 30 billion active cultures of a Lactobacillus rhamnosus bacteria strain.
All remaining claim rejections made under 35 USC 103 of the previous Office action have been maintained for reasons of record.
NEW: Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6, 7, 21-23, 25-27, 29-31 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amended claim 1 requires “wherein the high efficacy strain comprises at least approximately 30 billion active cultures of a Lactobacillus rhamnosus bacteria strain”. However, the specification states “[i]n some implementations, rather than a first set of probiotics including a high efficacy strain, the first set of probiotics may include a strain (e.g., strain such as those included in the second set of probiotics) in a magnitude greater than approximately 30 billion cultures per administered dose.” See published application, [0064]. Based on such disclosure, it is viewed that applicant intended that the high efficacy strain comprises at least approximately 30 billion active cultures of a Lactobacillus rhamnosus bacteria strain. The remaining claims are rejected for depending on the base claim which fails to comply with the written description requirement.
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 1, 3, 4, 21, 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Rahm et al. (US 20160287644 A1, published on October 6, 2016) (“Rahm” hereunder) in view of Lusinski (“11 Surprising uses for Epsom salt in and around your house”, www.simplemost.com, February 11, 2016) in view of Natural Epsom Salt (Amoray Care, October 2014), Brainard (US 20140044809 A1, published on February 13, 2014) and Langford (US 20120076914 A1, published on March 29, 2012).
The amended claim 1 is directed to a method of orally administering one or more compositions to improve or maintain gastrointestinal health of an individual, method comprising:
Orally administering one or more cleanse compositions, wherein at least one of the cleanse compositions comprises:
approximately 20 cc to approximately 40 cc of magnesium sulfate;and approximately 4 ounces to approximately 5 ounces of fruit juice, and
wherein the fruit juice comprises blueberry juice;
wherein the one or more cleanse compositions cleanses a bowel of the individual in less than approximately 24 hours as determined by clear fluids leaving a gastrointestinal tract of the individual; and
orally administering one or more renew compositions after administration of the one or more cleanse compositions,
wherein at least one of the renew compositions comprises fiber and probiotic that comprises a high efficacy strain and at least one other bacteria strain,
wherein the high efficacy strain comprises at least approximately 30 billion active cultures of a Lactobacillus rhamnosus bacteria strain,
wherein the other bacteria strain comprises from about 8 billion to about 10 billion active cultures of Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus salivarius, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium longum, or combinations thereof,
wherein administration of the one or more renew compositions after the administration of the one or more cleanse compositions improves or maintains gastrointestinal health of an individual; and
orally administering one or more maintenance compositions after administration of the one or more renew compositions,
wherein at least one of the maintenance compositions comprises: one or more vegetarian-sourced digestive enzymes selected from the group consisting of mylase, protease, lactase, lipase, cellulase, maltase, hemicellulase and combinations thereof.
Rahm teaches a method of administering to a subject a cleansing formulation, a prebiotic formulation, a probiotic formulation and a nutritional formulation to fundamentally change the flora of the gastrointestinal tract to beneficially balance the intestinal flora and associated health benefits. See abstract. The reference teaches using a natural herbal laxative to cleanse the GI tract.
The differences between the Rahm’s method and the present inventions include:
the present invention employs different laxatives: magnesium sulfate and blueberry juice;
the present invention employs a higher amount of a probiotic; and
the present invention employs one or more vegetarian-sourced digestive enzymes.
Different laxatives: magnesium sulfate and blueberry juice;
Lusinski teaches that Epsom salt acts as an all-natural laxative and add lemon juice to suggests adding lemon juice to an Epsom salt solution (1 teaspoon in 4 oz of water) to improve the taste. See instant claim 3.
Natural Epsom salt teaches that magnesium sulfate is a saline laxative and used for relief of occasional constipation as the product “generally produces bowel movement in ½ to 6 hours”. See Uses; instant claims 24 and 25. The reference teaches the daily dose of 10-30 grams for adults and children 12 years and over. See Direction. The reference further teaches to dissolve the dose in 8 ounces of water.
Lusinski and Natural Epsom salt fail to teach blueberry juice.
Brainard teaches a composition for digestive system, comprising blueberry product such as blueberry fiber, blueberry fruit, blueberry extract, and the like. The reference also teaches that a liquid dosage form can contain blueberry fruit in an amount ranging from about 0.1 %w/v to about 10 % w/v. See [0008]. Such form of blueberry product inherently contains blueberry juice. The reference teaches that blueberry products (i.e., fiber, fruit, extract) are beneficially used to impart color or taste in the final product, “as well as assisting in relief of the digestive condition.” See [0034] (emphasis inserted). The reference also teaches that the fiber can contain juice or can be solid remains of the fruit after juice removal by pressing. See [0035]. The reference further teaches that blueberry fruit can be available as powder or in liquefied, frozen or concentrated form. See [0038].
It is well settled in patent law that substituting equivalents know for the same purpose is prima facie obvious. See MPEP 2144.06, II. Rahm, Lusinski and Natural Epsom Salt establish that the herbal formulation in Rahm and the Epsom salt solution are both well known as natural laxative, substituting one for the other for the same purpose would have been prima facie obvious.
Given the teachings in Lusinski to add a fruit juice to improve the taste of the laxative composition comprising magnesium sulfate, one of ordinary skill in the art would have found it obvious to use commonly used flavoring ingredient to do so. Using blueberry juice as motivated by Brainard would have been obvious as this reference teaches that blueberry is used to impart flavor and color in orally administered pharmaceutical compositions and capable of assisting in relief of the digestive conditions. Since Brainard teaches that blueberry fruit can be used as powder or in liquid composition, and Lusinski and Natural Epsom Salt teach that magnesium sulfate is provided as solid and mixed in water before use, one of ordinary skill in the art would have had a reasonable expectation of successfully producing an Epsom salt laxative composition with improved taste by mixing blueberry fruit of either form to make magnesium sulfate dissolved in water containing blueberry juice or blueberry juice which inherently contains water. See instant claims 1 and 3.
Regarding the amount of the magnesium sulfate and blueberry juice, adjusting the amounts for targeted laxative result and taste would have no more than routine experimentations by one of ordinary skill in the art. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, Natural Epsom salt teaches using 10-30 grams (10-30 cc) of Epsom salt for adults and children over 12 years old in 8 ounces of water, while adding a fruit juice for taste. Since a fruit juice can be in any concentration, using a suitable amount of a fruit juice or blueberry juice for the desired taste would have been well within the skill in the art.
Claim 1 further states the method present cleansing method is “for cleansing a bowel in less than approximately 24 hours as determined by clear fluids leaving a gastrointestinal tract of the individual”. Any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation. See, MPEP 2111.02; Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962, 1966 (Fed. Cir. 1989) (The determination of whether preamble recitations are structural limitations can be resolved only on review of the entirety of the application "to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "'extraneous' limitations from the specification.") In this case, the newly added phrase in claim 1 contains no affirmative or positive method step, and amounts to an intended future use of the present method; since no structural limitation is present in the phrase, it is treated as a preamble and not a limitation. Since the Natural Epsom salt teaches that administering the salt product “generally produces bowel movement in ½ to 6 hours”, the cleansing can be produced within 24 hours; the reference further teaches that the administration can be repeated within the same day. Thus, the bowel cleansing method taught and suggested by prior art is capable and suitable to produce the results as recited in the preamble.
Higher amount of Lactobacillus rhamnosus
Claim 1 further requires orally administering one or more renew compositions after administration of the one or more cleanse composition, wherein at least one of the renew compositions comprises fiber and probiotic that comprises a high efficacy strain and at least one other bacteria strain, wherein the high efficacy strain comprises at least about 30 billion active cultures of a Lactobacillus rhamnosus bacteria strain, and wherein the other bacteria strain comprises from about 8 billion to about 10 billion active cultures of Lactobacillus acidophilus; Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus salivarius, Bificobacterium bifandus, bifidobacterium lactis, and bifidobacterium longum.
Rahm teaches administering to the subject a composition comprising probiotics such as Lactobacillus rhamnosus and Bifidobacterium lactis. See [0025, 0037]. The reference teaches that the probiotic formulation is “designed to rebalance the microbiome with beneficial bacteria” to support a healthy weight. The reference teaches that such probiotic formulations can include two or three species of Lactobacillus such as L. plantarum, L. rhamnosus, and L. gasseri. See [0007]. The reference teaches that the probiotics are in the range of 10-30 billion CFUs and formulated to ensure that at least 15 billion live bacteria is delivered through out the digestive tract. See [0007]. Although the reference does not specifically require “at least about 30 billion” active cultures of L. rhamnosus bacteria, increasing the amount of the beneficial bacteria for delivery of a more potent dose would have been prima facie obvious, absent showing of criticality of the range “at least approximately 30 billion active cultures” of a L. rhamnosus bacteria strain.
Rahm further teaches that such probiotic formulation is used to boost the number and diversity of beneficial bacteria in the digestive tract and provided in the amount of 10-25 billion CFUs. The reference further teaches administering to the subject a prebiotic composition and a nutritional composition after the cleansing of the GI track, wherein the prebiotic and nutritional compositions comprise insoluble or soluble fiber, see [0051], and/or maltodextrin (Fiberol-2) which is a dietary fiber. The reference teaches that a prebiotic fiber serves as a supportive substrate for the desired bacteria. See [0054]. The reference teaches that the disclosed method “reduces undesired microorganism in the GI tract. See [0057]. Since these compositions are administered either sequentially or simultaneously, co-administering of these components in a single composition would have been obvious; and since the prebiotic fiber is used as a supportive substrate for the desired bacteria, combining fiber and probiotic in a single composition would have been prima facie obvious.
One or more vegetarian-sourced digestive enzymes:
Claim 1 further requires a method step of “orally administering one or more maintenance compositions after administration of the one or more renew compositions, wherein at least one of the maintenance compositions comprises: “wherein at least one of the maintenance compositions comprise: one or more vegetarian sourced digestive enzymes of amylase, protease, lactase, lipase, cellulose, maltase, hemicelullase, or combinations thereof.”
Although Rham generally teaches to promote the health of the digestive track and stimulate digestive function, the reference fails to teach the enzymes of the present claim. See [0005].
Langford teaches that dietary supplements comprising alpha-amylase is commercially available as a digestive enzyme which facilitates increased nutrient release. See [0020]. The reference teaches an embodiment which contains both probiotic and a digestive enzyme.
Given the teachings and suggestions of Rham to administer formulations to the subject to help the digestive system, it would have been obvious to one of ordinary skill in the art before the effective date of the present application to look to prior art such as Langford for further teachings of beneficial components for digestive functions. Since the reference further teaches that the enzyme facilitates increased nutrient release when administered and could be co-administered with probiotics, the skilled artisan would have had a reasonable expectation of successfully improving digestive health of the subject by combining the teachings of the references.
Regarding claim 4, Brainard suggests using additional fruit extracts such as grape extracts. Since Brainard teaches that reconstituting grape extracts would obviously generate grape juice, using grape extract as suggested by Brainard would meet the present limitation.
Regarding claim 21 and 22, Ockerman teaches that the probiotic composition imparts the benefits of maintaining the balance of microflora in the intestine, thus repeated use of the composition to maximize the effect would have been obvious. For example, Ockerman teaches that patients who were treated with the probiotic compositions comprising Lactobacillus rhamnosus, inulin and dried powder of blueberries.
Claim 21 requires that the “the one or more maintenance compositions are not the same as the one or more renew compositions.” Ockerman teaches that the probiotic composition can further contain vitamins, mineral, amino acids, antioxidants, etc. to delay or prevent the onset of a disease and/or condition associated with oxidative stress. Thus, incorporating at least one of these components according to the teachings or suggestions to make a composition and administering to patients as a part of the health care regime would have been obvious.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Rahm, Lusinski, Natural Epsom Salt, Brainard and Longford as applied to 1, 3, 4, 21, 22 and 25 above, and further in view of Koo et al. ("Pharmacological Effects of Green Tea on the Gastrointestinal System," European Journal of Pharmacology 500:177-184 2004) (“Koo” hereunder) and Higashiguchi et al. (US 20100330197 A1, published on December, 2010) (“Higashiguchi” hereunder).
Rahm fails to teach green tea.
Koo teaches that green tea consumption reduces colorectal cancer risk; provides a protective effect on the gastrointestinal mucosa, reduces the absorption of fat and sugar, etc.
Furthermore, Higashiguchi teaches that green tea is used as a flavoring agent in orally administered pharmaceutical composition. The reference teaches using “a taste component such as sodium chloride, sodium glutamate, fruit juice or the like, and flavors such as pineapple flavor, lemon flavor, orange flavor, coffee flavor, green-tea flavor, milk flavor or the like”. See [0117].
It would have been obvious to one of ordinary skill in the art before the time of filing of the present application to modify the teachings of Rahm and add to the cleansing or probiotic compositions green tea as motivated by Koo and Higashiguchi. The skilled artisan would have been motivated to do so, as Koo teaches that green tea consumption lowers the risk of colorectal cancer and protects the gastrointestinal mucosa and reduces the absorption of fat and sugar, and Higashiguchi teaches that green tea is used as a flavoring agent in pharmaceutical art. Since Lusinski teaches using a flavoring agent such as lemon juice, the skilled artisan would have had a reasonable expectation of successfully producing a laxative composition with green tea flavor and improved health benefits.
Claims 6 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Rahm, Lusinski, Natural Epsom Salt, Brainard and Longford as applied to 1, 3, 4, 21, 22 and 25 above, and further in view of Taniguchi et al. (US 20160008392 A1, published on January 14, 2016) (“Taniguchi” hereunder).
Rahm generally teaches using stevia. See [0026].
Taniguchi further teaches stevia extract is or enzyme treated stevia is a high intensity sweetener used in orally administered pharmaceutical compositions. See [0018].
Regarding claims 6 and 23, it would have been obvious to one of ordinary skill in the art before the time of filing of the present application to modify the teachings of Rahm, Natural Epsom Salt and Lusinski and add to the cleansing or probiotic composition stevia as motivated by Taniguchi. The skilled artisan would have been motivated to do so with a reasonable expectation of successfully improving the taste of the cleansing composition as 1) Lusinski teaches adding a flavoring agent to improve the taste; and 2) Taniguchi teaches that stevia is a well-known high intensity sweetener used to improve tastes of orally administered pharmaceutical compositions.
Claims 7, 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Rahm, Lusinski, Natural Epsom salt, Brainard and Longford as applied to claims 1, 3, 4, 21, 22 and 25 as above, and further in view of Ockerman (US 20140161878 A1, published June 12, 2012).
Although Rahm teaches administering to the subject a prebiotic and a nutritional composition comprising dietary fiber, the reference fails to teach blueberry fiber.
Brainard teaches that blueberry fiber can contain juice or can be solid remains of the fruit after juice removal by pressing, thus using such fiber is obvious. See [0035]. The reference teaches that blueberry products, including the fiber, can assist in relief of the digestive condition, such as reducing acid in the upper GI track. See [0029].
Regarding claim 7, Ockerman discloses a probiotic composition for oral administration, the composition comprising probiotics such as lactobacillus rhamnosus and dried fruit powder of blueberries. See instant claim 7. Such powder inherently contains fiber. Although the reference doesn’t disclose whether such fiber comes are solid remnants of blueberries after juicing, the fiber from same fruit would be inherently the same regardless of how it is obtained.
It would have been obvious to one of ordinary skill in the art before the time of filing of the present application to modify the teachings of Rahm and orally administer to the user a composition comprising probiotic and blueberry fiber as Brainard teaches that blueberry products, including the fiber, can assist in relief of the digestive condition, such as reducing acid in the upper GI track. The skilled artisan would have had a reasonable expectation of successfully administering a stable composition comprising probiotics and blueberry fiber in power form as Ockerman teaches such composition for promoting health and Brainard teaches blueberry powder can reduce acid in the upper GI track.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Rahm, Lusinski, Natural Epsom Salt, Brainard and Longford as applied to 1, 3, 4, 21, 22 and 25 above, and further in view of Fine (US 20060018843 A1, published on January 26, 2006)
Rahm fail to disclose the topical method as defined in present claim 29.
Fine teaches a method for treatment and prevention of oral hygiene, halitosis, gingivitis, and/or periodontitis, the method comprising topically applying an oral composition comprising a variety of one or more probiotic bacteria from the groups Lactobacillus, Bacillus, Escherichia, Enterococcus, Streptococcus, and Bifidobacterium, and/or a species of the yeast genus Saccharomyces in an orally acceptable medium. See [0021]. Such formulations can be oral spray, chewing gum, candy, lozenges, dissolvable pill or strip or powder that may be sprinkled directly into the oral cavity. The reference teaches that the method encourages the growth of probiotic bacteria, which in turn inhibits the growth of more harmful bacteria, such as Bacteroides and other genera in the oral cavity and the distal gastrointestinal tract or raises the pH of the saliva in the mouth, which discourages growth of the bacteria, etc.
It would have been obvious to one of ordinary skill in the art before the time of the effective filing date of the present application to modify the teachings of Rahm and further include a method of topically treating the oral cavity with probiotic as motivated Fine. The skilled artisan would have been motivated do so, as 1) Rahm is directed to multiple treatment method steps to “fundamentally change the flora of the gastrointestinal tract” and alter the microbiome; and 2) Fine teaches a method of topically treating the oral cavity may aid in change of flora in the oral cavity and the distal gastrointestinal tract. Since Rahm and Fine are both directed to methods for gastrointestinal and/or oral health by altering microbiome, the skilled artisan would have had a reasonable expectation of successfully enhancing the Rahm method for treating gastrointestinal health as well as providing an oral hygiene regime.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Rahm, Lusinski, Natural Epsom Salt, Brainard, Longford and Fine as applied to 1, 3, 4, 21, 22, 25 and 29 as above, and further in view of Yudina et al. (US 20160166501 A1, effective filing date July 5, 2013) (“Yudina” hereunder).
Although Fine generally teaches using a species of the probiotic organisms such as Lactobacillus, Streptococcus, etc., the reference fails to disclose the specific species.
Yudina teaches compositions for oral hygiene containing Lactobacillus helveticus, Lactobacillus plantarum, in combination of Streptococcus salivarius K12, which treats or prevents dental caries, halitosis, gingivitis, periodontal disease, etc. See [0020-0021]. Suitable carriers include powder, solutions, etc. See [0028].
Given the teachings of Fine to include Lactobacillus species and Streptococci bacteria useful in the anti-caries dental powder, one of ordinary skill in the art would have been obviously motivated to look to prior art such as Yudina for the specific species of these bacteria. Since Yudina discloses the names of the specific Lactobacillus (e.g., L. plantarum) and non-pathogenic Streptococci bacteria (e.g., S. salivarius K12) that are topically used to treat or prevent dental caries, halitosis, gingivitis, periodontal diseases, etc., the skilled artisan would have had a reasonable expectation of successfully practicing the Fine method with the Yudina composition by combining the teachings of the references.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Rahm, Lusinski, Natural Epsom Salt, Brainard, Longford and Fine as applied to 1, 3, 4, 21, 22, 25 and 29 as above, and further in view of Gobbi (WO2007000648 A1, published on January 4, 2007).
Fine fails to specifically require administering a dental powder or a mouthwash to the mouth of the user prior to administering the oral probiotic composition. However, prior cleaning or washing the area to be topically treated is an obvious step to ensure removal of plaque as well as bad bacteria and the proper contact of the beneficial microorganisms on the targeted area. For example, Gobbi teaches a method of topically applying a pharmaceutical formulation containing colostrum and calcium folinate after cleaning the teeth. See p. 3, lines 10-15. Furthermore, Rahm also teaches that the first cleansing formulation is used “to provide a foundational clean slate” to favorably alter the microbiome, and then a probiotic formulation is administered. See [0005].
Thus, 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 Fine and cleaning the oral cavity prior to topically treating it with the probiotic composition to enhance the method of altering the microbiome in the oral cavity.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Rahm, Lusinski, Natural Epsom Salt, Brainard, and Longford as applied to 1, 3, 4, 21, 22 and 25 as above, and further as evidenced by Sokhey et al. (US 20030082277 A1, published May 1, 2003) (“Sokhey” hereunder).
Although Rahm does not specifically disclose that the probiotics are provided in dry form, Longford teaches a formulation comprising probiotics and enzymes in dry powder form and encapsulated with fish oil. See [0028-0037]. Sokhey teaches that probiotics are naturally in a dormant state when dry and protected from moisture and nutrients when encapsulated in liquid fat. See [0038]. It follows that the probiotic formulation made according to the teachings of Longford is in dormant state and would be revived by rehydration from digestive fluid when consumed.
Response to Arguments
Applicant’s arguments filed on November 20, 2025 regarding the rejections made under 35 U.S.C. 103 have been fully considered but they are not moot in view of the new grounds of rejection as indicated above in part and unpersuasive in part.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. In this case, administering to a subject a multi-step regime for alter and improve gut health is old and well known. Rham teaches a system which includes 1) a cleanse composition, 2) prebiotic (fiber) and probiotic compositions; and 3) a nutritional composition. In view of the cited references, the presently claimed invention is viewed obvious variations and modifications to achieve the same purpose of Rham, which is “to cleanse, nourish, replenish, feed and boost the microbiome” to promote health benefits.
Applicant argues that each rejection is improper and combining the teachings of the references would not have been obvious, without specifically providing reasons. The examiner respectfully points out that each rejection is supported by objective reasons found in the cited references. The examiner respectfully points out that the basis of the obviousness rejection in this case is what one of ordinary skill in the art before the earliest filing date of the present application would have found obvious and motivated to do in view of prior art teachings.
Regarding claim 2, applicant asserts that using green tea would not have been obvious, without providing explanation. As indicated above in the rejection, Koo teaches that green tea consumption lowers the risk of colorectal cancer and protects the gastrointestinal mucosa and reduces the absorption of fat and sugar, and Higashiguchi teaches that green tea is used as a flavoring agent in pharmaceutical art. In view of such health benefits and formulation benefits, adding green tea in the cleansing composition would have been prima facie obvious.
Regarding claims 6 and 23, applicant asserts that Taniguchi fails to teach adding stevia in the specific amounts. It was indicated in the rejection that stevia was used to improve taste, and determining suitable amounts of sweetener to improve taste would have taken no more than ordinary skill in the art.
Regarding claims 7, 26 and 27, applicant argues that Brainard and Ockerman “do not teach” using pomace-derived blueberry fiber or other fruit fibers in a renew composition. The examiner respectfully points out that the basis of the obviousness rejection in this case is what one of ordinary skill in the art before the earliest filing date of the present application would have found obvious and motivated to do in view of prior art teachings. Because of the known benefits of blueberry fibers in digestive condition and known use of dried fruit powder of blueberries with probiotics, adding blueberry fibers in the probiotic composition in Rahm to would have been prima facie obvious.
Similarly, regarding claim 29, the rejection has been made in view of prior art teachings would have motivated one of ordinary skill in the art to combine the teachings of the references. Oral treatment with probiotic is old and well known hygiene routine per Fine, and nothing unobvious or surprising is seen in applying such method
Regarding claims 30 and 31, applicant provides no explanation why the combining the cited references is unobvious.
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