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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/25/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/26/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawal of Rejections
The response and amendments filed on 11/25/2025 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, or maintaining, if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s Response to Arguments section.
Briefly, the previous drawing objections have been withdrawn necessitated by Applicant’s submission of new drawings.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 30 is objected to because of the following informalities: “ug” should be “µg”. Appropriate correction is required. This is an objection, not a rejection, because it appears this is a typographical error.
Claim Rejections – 35 USC § 112(b), Indefiniteness
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.
Claims 1, 16-17, 19, 21-22, 24, 27, 30, 33, 36, 38-42, 45, 50, and 54-55 are rejected under 35 U.S.C. 112(b) 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.
Claims 1, 17, 19, and 24 recite “SCFAs”; however, abbreviations must be completely spelled out upon first recitation. The instant specification does not define what SCFAs are; however, for the purposes of applying prior art, the Examiner has interpreted SCFAs to mean short chain fatty acids.
Claim 50 recites “(sodium salt)” in parentheses; however, it is unclear if this is part of the claimed invention, or a preferred embodiment. For the purposes of applying prior art, the Examiner has interpreted this to be a preferred embodiment and not part of the claimed invention.
Claims 16, 21-22, 27, 30, 33, 36, 38-42, 45, and 54-55 are included in this rejection of depending on rejected independent claim 1 and failing to rectify the noted deficiency.
Claim Rejections - 35 USC § 101, Ineligible Subject Matter
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 16-17, 19, 21, 40-42, 45, and 54-55 are rejected under 35 U.S.C. 101 because they are drawn to ineligible subject matter (based on the 2019 Revised Patent Subject Matter Eligibility Guidance).
Broadest reasonable interpretation (BRI) of independent claim 1: the broadest scope of claim 1 is drawn to a composition comprising bromelain, SCFAs, amino acids, and vitamin D or alfacalcidol.
STEP 1: Is the claim directed to a process, machine, manufacture, or composition of matter?
YES, the claims are directed to a composition of matter.
STEP 2A: PRONG ONE: Does the claim recite an abstract idea, law of nature, or a natural phenomenon?
YES, the claims are considered to be “product of nature” exceptions (i.e., a mixture of naturally occurring products). The courts have held that “products of nature” fall under the law of nature and/or natural phenomena exceptions.
PRONG TWO: Does the claim recite additional elements that integrate the judicial exception into a practical application?
NO, the additional elements or combination of elements in the claims does not impose a meaningful limit on the judicial exception. Note that the markedly different characteristics analysis is used to determine if a nature-based product is a “product of nature” exception. Thus, the markedly different characteristic analysis is part of step 2A, i.e., it helps answer the question of whether a claim is directed to an exception, which is further explained below.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
NO, the claimed invention is directed to a law of nature and/or natural phenomenon (i.e., product of nature) without significantly more. Note that the claims must be interpreted under the broadest reasonable interpretation (BRI) standard when evaluating for marked difference. Under BRI, the claims broadly read on bromelain, SCFAs, amino acids, and vitamin D or alfacalcidol.
Bromelain is obtained from the fruit and step of pineapple and is a naturally occurring “mixture of different thiol endopeptidases and other components like phosphatase, glucosidase, peroxidase, cellulase, escharase, and several protease inhibitors” (see, e.g., Pavan, abstract; Properties and Therapeutic Application of Bromelain: A Review; 2012 – newly cited). SCFAs are naturally produced end products of fermentation of dietary fibers by anaerobic intestinal microbiota (see, e.g., Besten, previously cited). Amino acids are naturally occurring and can be produced within the human body or obtained from natural food sources (see, e.g., Gorska-Warsewicz, abstract & introduction; Food Products as Sources of Protein and Amino acids – The Case of Poland; 2018 – newly cited). Vitamin D can be obtained naturally from food, such as salmon, tuna, and mackerel, liver, egg yolk, and some dairy products, as well as from sunlight (see, e.g., Parkview Health; The 3 sources of Vitamin D; 2016).
Moreover, the claims reciting the different oral dosage forms are included in this rejection because these dosage forms are considered containers for the judicial exceptions. Merely placing the judicial exceptions into a generic container, such as an oral dosage form, does not add meaningful limitation and does not result in a markedly different characteristic for the product (see, e.g., MPEP 2106.04(c)).
There is no indication that the claimed composition has any markedly different characteristic (e.g., structure, function, phenotype, etc.) that is different than what is found in nature. Applicant does not provide evidence showing that the bromelain, SCFAs, amino acids, and vitamin D interact to produce a different structure or characteristic than what is found in nature. Therefore, it appears that the Applicant is merely claiming a naturally occurring product. Moreover, note that MPEP 2106.04(b) also states: “Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or invention. Instead the key to the eligibility of all non-naturally occurring products is whether they possess a markedly different characteristic from any naturally occurring counterpart.”
Therefore, the claims are interpreted under the BRI standard, wherein the claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements.
Therefore, the claims, as a whole, are considered products of nature which are directed to judicially recognized exceptions without amounting to significantly more from what occurs in nature and thus, are not eligible under 35 U.S.C. 101.
Claim Rejections – 35 USC § 103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 16-17, 19, 21-22, 24, 27, 30, 33, 36, and 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Rabovsky (US 2016/0193306; Date of Publication: July 7, 2016 – previously cited) in view of Simon (WO 2017/184766; Date of Publication: October, 26, 2017 – previously cited) and Besten (The Role of Short-Chain Fatty Acids in the Interplay between Diet, Gut Microbiota, and Host Energy Metabolism, 2013 – previously cited).
Rabovsky’s general disclosure relates to dietary supplements for animal or human consumption that features a “multi-supplement composition comprising (a) a probiotic supplement; (b) a multivitamin and mineral supplement; (c) an antioxidant supplement; and (d) an anti-inflammatory supplement” (see, e.g., Rabovsky, [0003], [0007]). Moreover, Rabovsky discloses that the compositions can be used to reduce pain and inflammatory conditions (see, e.g., Rabovsky, [0109], [0114]-[0115], [0121], [0152]).
Regarding claims 1, 16-17, and 21 pertaining to a composition, Rabovsky teaches supplement formulations comprising bromelain (see, e.g., Rabovsky, [0023]-[0026]), fatty acids (see, e.g., Rabovsky, [0273]), natural amino acids selected from the group consisting of “L-alanine, L-arginine, L-asparagine, L-aspartic acid, L-cysteine, L-glutamic acid, L-glutamine, L-glycine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, L-valine” (see, e.g., Rabovsky, [0173]), and vitamin D3 (see, e.g., Rabovsky, [0040]).
Regarding claim 30 pertaining to the dose of vitamin D, Rabovsky teaches the effective amount of vitamin D within a formulation is 2,000 IU, which is equivalent to 50 µg of vitamin D (see, e.g., Rabovsky, [0245]).
Regarding claim 33 pertaining to the dose of the composition, Rabovsky teaches a supplement formulation that comprise 1.25 g of a composition (see, e.g., Rabovsky, [0298]) and that the it is in oral dosage form (see, e.g., Rabovsky, [0212]).
Regarding claim 36 pertaining to the dose of vitamin D, Rabovsky teaches the effective amount of vitamin D within a formulation is 2,000 IU, which is equivalent to 50 µg of vitamin D (see, e.g., Rabovsky, [0245]). Rabovsky teaches that the vitamin D used is vitamin D3 (see, e.g., Rabovsky, [0040]).
Regarding claim 54 pertaining to a composition, Rabovsky teaches that the vitamin D used is vitamin D3 (see, e.g., Rabovsky, [0040]).
Regarding claim 55 pertaining to an oral dosage form, Rabovsky teaches that the supplement formulations can be formulated for oral administration (see, e.g., Rabovsky, [0212]).
However, Rabovsky does not teach wherein the composition is comprised of one or more SCFAs or esters thereof (claims 1(b) and 16); or wherein the one or more SCFA or ester thereof is sodium butyrate, calcium butyrate, sodium propionate or sodium acetate (claim 19); or wherein the composition consists of sodium butyrate (claim 21); or wherein the composition is a unit dosage form that comprises about 50-2500 mg of bromelain (claim 22); or wherein the composition is a unit dosage form that comprises about 45-1800 mg SCFA (claim 24); or wherein the composition is unit dosage form that comprises about 67.5-2700 mg L-threonine, L-tryptophan, L-glutamine, L-arginine or L-methionine or any combination thereof (claim 27); that the oral dosage form comprises 50-2500 mg bromelain, 45-1800 mg sodium butyrate, and 67.5-2700 mg L-threonine (claim 36).
Simon’s general disclosure relates to “compositions (for example, nutritional compositions or therapeutic compositions) that comprise a probiotic component, colostrum, a protein component, and a detoxification component” (see, e.g., Simon, abstract). Furthermore, Simon teaches the composition can be used for “restoring and preserving the integrity of tissue barriers”, including the gastrointestinal tract (see, e.g., Simon, [0002]). Moreover, Simon discloses “methods of preventing or treating a disturbance in the integrity of a tissue barrier and/or a mucosal membrane adjacent to or on a tissue of an individual and preventing or treating resulting diseases or conditions by administering such compositions to the individual” (see, e.g., Simon, abstract). Furthermore, Simon teaches that the composition comprises sodium butyrate, bromelain, SCFAs, and amino acids (see, e.g., Simon, [0055], [0061], table 5, and table 9).
Regarding claims 1(b), 16, 19, and 21 pertaining to SCFAs or esters, Simon teaches a composition that consists of sodium butyrate (see, e.g., Simon, [0061]).
Regarding claims 22 and 36 pertaining to the dose of bromelain, Simon teaches that the composition comprises bromelain at a dose of 50-450 mg (see, e.g., Simon, pg. 18, table 9).
Regarding claims 24 and 36 pertaining to the dose of SCFAs, Simon teaches that the composition comprises sodium butyrate at a dose of 25-300 mg (see, e.g., Simon, pg. 16, table 5).
Regarding claims 27 and 36 pertaining to the dose of L-threonine, Simon teaches that the composition comprises threonine at a dose of 630 mg (see, e.g., Simon, pg. 19, [0055]).
Besten’s general disclosure relates to “the role of SCFAs in host energy metabolism, starting from the production by the gut microbiota to the uptake by the host and ending with the effects on host metabolism” (see, e.g., Besten, pg. 2325, abstract). Moreover, Besten discloses “In clinical studies SCFA administration positively influenced the treatment of ulcerative colitis, Crohn’s disease, and antibiotic-associated diarrhea” (see, e.g., Besten, pg. 2326, Introduction.
Regarding claims 1(b) and 16 pertaining to SCFAs, Besten teaches SCFAs are an important end product of fermentation of dietary fibers by anaerobic intestinal microbiota (see, e.g., Besten, pg. 2325, abstract) and “might play a key role in the prevention and treatment of the metabolic syndrome, bowel disorders, and certain types of cancer” (see, e.g., Besten, pg. 2326, introduction).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select or substitute fatty acids, as taught by Rabovsky, for SCFAs, such as sodium butyrate, as taught by Simon and Besten. One would have been motivated to do so because Besten teaches that SCFAs plays an important end product of fermentation of dietary fibers by anaerobic intestinal microbiota (see, e.g., Besten, pg. 2325, abstract) and suggests that it “might play a key role in the prevention and treatment of the metabolic syndrome, bowel disorders, and certain types of cancer” (see, e.g., Besten, pg. 2326, introduction) which is one of the objectives of Rabovsky directed to the prevention and treatment of metabolic syndrome (see, e.g., Rabovsky, [0390]). Moreover, Rabovsky and Besten both teach that compositions comprising bromelain, SCFAs, amino acids, and vitamin D improve overall health and play important roles within the GI tract (see, e.g., Rabovsky, [0006] & Besten, pg. 2326, introduction). Furthermore, Simon teaches compositions comprising omega-3 polyunsaturated fatty acids in order to treat GI conditions (see, e.g., Simon, [0061]). One would have expected success since Rabovsky, Simon, and Besten teach that the supplemental formulations can be used to reduce the risk of a variety of diseases (see, e.g., Rabovsky, [0114] & Besten, pg. 2326, introduction & Simon, [0061]), and Rabovsky and Simon both teach compositions comprising bromelain for treatment of gastrointestinal diseases.
It would have been secondly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Rabovsky’s composition, wherein the doses of bromelain, SCFAs, and L-threonine are 50-450 mg, 25-300 mg, and 630 mg, respectively, as taught by Simon. One would have been motivated to do so because Rabovsky and Simon teach the same composition components (i.e., bromelain, SCFAs, amino acids, and vitamin D) within various supplement formulations, that can be administered orally, and which play important roles within the GI tract (see, e.g., Besten, pg. 2326, introduction). Moreover, Simon teaches that these composition components may help with tissue disturbance and symptomatic relief of symptoms related to GI disease and disorders (see, e.g., Simon, abstract, [0003]). Therefore, since Simon teaches the same composition as Rabovsky, and Rabovsky and Simon have the same motivation of treating GI disorders, it would have been obvious to apply the dosages taught by Simon to Rabovsky’s composition. One would have expected success because Rabovsky and Simon teach the same composition components for treating GI disorders.
Regarding claim 1 pertaining to the recitation of “for improving a parameter associated with a gastrointestinal disorder”, this is considered intended use and does not limit the structure of claim 1 (see, e.g., MPEP 2111.02). Therefore, claim 1 is presumed satisfied by the structurally complete invention recited within the body of independent claim 1.
Regarding claim 1 pertaining to the recitation of “where the composition reduces IL-8 secretion”, this would be inherent. The combined prior art of Rabovsky, Simon, and Besten teaches the same composition comprising bromelain, one or more SCFAs, one or more amino acids, and vitamin D, which would inherently lead to the same effect of reducing IL-8 secretion since the inherent properties exhibited by the composition would be present (see, e.g., MPEP 2112.02).
Regarding claims 22, 24, 27, 30, and 36’s concentration limitations, those working in the biological and/or pharmaceutical arts would understand that the adjustments of particular conventional working conditions (e.g., concentration or amount of a compound) is deemed a matter of judicious selection and routine optimization, which is in the purview of the skilled artisan (see, e.g., MPEP 2144.05). For example, Rabovsky teaches compositions comprising bromelain (see, e.g., Rabovsky, [0023]-[0026]), fatty acids (see, e.g., Rabovsky, [0273]), natural amino acids selected from the group consisting of “L-alanine, L-arginine, L-asparagine, L-aspartic acid, L-cysteine, L-glutamic acid, L-glutamine, L-glycine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, L-valine” (see, e.g., Rabovsky, [0173]), and vitamin D3 (see, e.g., Rabovsky, [0040]). Moreover, Rabovsky states “when the administration forms are compatible as is known to those skilled in the art, the various ingredients in the Supplement Formulations A-N can be combined in different tablets, capsules, powder, softgel, etc. arrangements than those listed herein” (see, e.g., Rabovsky, [0082]). Furthermore, Simon teaches compositions comprising bromelain, SCFAs, L-threonine, and vitamin D (see, e.g., Simon, [0055], [0061], [0087]). Additionally, Simon states “Those skilled in the art will recognize that several embodiments are possible within the scope and spirit of this invention” (see, e.g., Simon, [0218]) and “t will be apparent to those skilled in the art that certain changes and modifications may be practiced without departing from the invention” (see, e.g., Simon, [0337]). This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning these concentrations, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variables which can be met as a matter of routine optimization.
Claims 38-42 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Rabovsky, Simon, and Besten as applied to claims 1, 16-17, 19, 21-22, 24, 27, 30, 33, 36, and 54-55 above, and further in view of Talaei (Overcoming Therapeutic Obstacles in Inflammatory Bowel Diseases: A Comprehensive Review on Novel Drug Delivery Strategies, 2013 – previously cited) and Friend (Drug Delivery to the Small Intestine, 2004 – previously cited).
The combined teachings of Rabovsky, Simon, and Besten, herein referred to as modified-Rabovsky-Simon-Besten, are discussed above as it pertains to a composition comprising bromelain, SCFAs, amino acids, and vitamin D.
Regarding claims 40-42 and 45 pertaining to the oral dosage form comprising bromelain, L-threonine, sodium butyrate, and vitamin D, modified-Rabovsky-Simon-Besten teaches a composition comprising bromelain, L-threonine, sodium butyrate, and vitamin D (see, e.g., Rabovsky, [0023]-[0026], [0040], [0173], [0273]) & Simon, [0061]).
However, modified-Rabovsky-Simon-Besten does not teach wherein the oral dosage form comprises two different types of pills, tablets, minitabs, capsules, granules, particles or microparticles, wherein each different type is formulated to release its contents to a different part of the gastrointestinal tract (claim 38), or wherein the different parts of the gastrointestinal tract are the duodenum and the colon (claim 39), or wherein the oral dosage form is comprised of two different types of pills, tablets, minitabs, capsules, granules, particles or microparticles that are Type A and Type B pills, tablets, minitabs, capsules, granules particles or microparticles, wherein the Type A and the Type B pills, tablets, minitabs, capsules, granules, particles or microparticles each comprise at least one component, or at least two components, of the composition (claim 40), or wherein the oral dosage form is comprised of Type A and Type B pills, tablets, minitabs, capsules, granules, particles or microparticles wherein the Type A and Type B pills, tablets, minitabs, capsules, granules, particles or microparticles each comprise at least one different component of the composition than each other, or at least two different components of the composition from each other (claim 41), or wherein the Type A pills, tablets, minitabs, capsules, granules, particles or microparticles comprise of bromelain (claim 42), or wherein the Type B pill, tablet, minitab, capsule, granule, particle or microparticle comprises L-threonine, sodium butyrate and Vitamin D (claim 45).
Talaei’s general disclosure relates to therapeutic approaches and novel drug delivery systems for the treatment of irritable bowel disease (see, e.g., Talaei, abstract). Additionally, Talaei teaches drug delivery approaches for specific targeting to the colon (see, e.g., Talaei, pg. 714, section 3). Moreover, Talaei discloses “Therapeutic side effects and efficacy considerations necessitate the development of more effective systems which lower the required drug doses, reduce systemic adverse effects and deliver the drug specifically to the desired site of action in colon. The large surface area in large intestine is suitable for drug absorption but the primary approaches to treatment depend on the gastrointestinal (GI) condition and its movements. Hereafter, there are novel GI-independent targeted drug delivery systems or therapeutic approaches, including micro- and nanoparticles that have been developed for IBD treatment and have the potential to overcome some of the current drawbacks of conventional IBD therapy” (see, e.g., Talaei, abstract).
Regarding claims 38-39 pertaining to oral dosage forms formulated to release its contents to the colon, Talaei teaches a tablet (see, e.g., Talaei, pg. 716, section 3.2) that contains “a combination of enteric coating and delayed-release elements makes it possible to achieve the targeted release of a drug in the ileum or colon” (see, e.g., Talaei, pg. 715, section 3.1.2).
Regarding claims 40-42 and 45 pertaining to the oral dosage forms comprising at least one or two components of the composition, Talaei teaches a tablet (see, e.g., Talaei, pg. 716, section 3.2).
Friend’s general disclosure relates to drug delivery systems for oral delivery of drugs to the small intestine (see, e.g., Friend, abstract). Additionally, Friend teaches that targeting of oral drugs to the small intestine allows for maximal absorption comparted to other regions of the GI tract (see, e.g., Friend, pg. 371, introduction).
Regarding claims 38-39 pertaining to oral dosage forms formulated to release its contents into the small intestine, Friend teaches “most oral dosage forms (tablets, capsules, liquids, and so on) are normally formulated to release or deliver the active agent (drug) in the small intestine (see, e.g., Friend, pg. 371, introduction). Moreover, Friend teaches the use of nanoparticles that are capable of adhering to the walls of the small intestine for improved oral delivery and bioavailability; thereby, allowing for “selective delivery to the small intestine” (see, e.g., Friend, pg. 373, “Technology).
Regarding claims 40-42 and 45 pertaining to the oral dosage forms comprising at least one or two components of the composition, Friend teaches particles, such as nanoparticles (see, e.g., Friend, pg. 373, “Technology).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce modified-Rabovsky-Simon-Besten’s composition within a tablet, as taught by Talaei, or within the nanoparticles, as taught by Friend. One would have been motivated to do so because incorporation of bromelain in the enterically-coated delayed-release tablet, as taught by Talaei, would allow for specific targeting of bromelain to the colon. Furthermore, incorporation of L-threonine, sodium butyrate, and vitamin D into the particles, as taught by Friend, would allow for specific targeting of these components to the small intestine. Additionally, Talaei and Friend teach that targeted delivery of therapeutics can be used to treat disorders within the GI tract, such as irritable bowel disease (see, e.g., Talaei, abstract). Moreover, modified-Rabovsky-Simon-Besten teach that compositions comprising bromelain, SCFAs, amino acids, and vitamin D improve overall health and play important roles within the GI tract (see, e.g., Rabovsky, [0006] & Besten, pg. 2326, introduction), and that the supplemental formulations can be used to reduce the risk of a variety of diseases (see, e.g., Rabovsky, [0114] & Besten, pg. 2326, introduction). Therefore, based on the teachings of modified-Rabovsky-Besten, Talaei, and Friend, it would have been obvious to produce a composition comprising bromelain, SCFAs, amino acids, and vitamin D, wherein the composition is produced into a tablet or nanoparticles, because this would allow for targeted release of the composition components into different areas of the GI tract in order to treat GI diseases/disorders. One would have expected success because modified-Rabovsky-Simon-Besten, Talaei, and Friend all teach the treatment of GI diseases/disorders.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Rabovsky, Simon, Besten, Talaei, and Friend as applied to claims 1, 16-17, 19, 21-22, 24, 27, 30, 33, 36, 38-42, 45, and 54-55 above, and further in view of Brien (Bromelain as a Treatment for Osteoarthritis: A Review of Clinical Studies, 2004 – previously cited), Pedrani (US 2018/0133166; Date of Publication: May 17, 2018 previously cited), Spector (US 2018/0214399; Date of Publication: August 2, 2018 – previously cited), Girsh (US 2009/0274660; Date of Publication: November 5, 2009 – previously cited), and Holstein (US 2016/0235822; Date of Publication: August 18, 2016 – cited in the IDS filed 10/12/2022 – previously cited).
The combined teachings of Rabovsky, Simon, Besten, Talaei, and Friend, herein referred to as modified-Rabovsky-Simon-Besten-Talaei-Friend, are discussed above as it pertains to a composition comprising bromelain, SCFAs, amino acids, and vitamin D, and targeted administration of the composition to either the duodenum or colon.
Regarding claim 50 pertaining to the unit dosage form, modified-Rabovsky-Simon-Besten-Talaei-Friend teach a tablet (see, e.g., Talaei, pg. 716, section 3.2) that contains “a combination of enteric coating and delayed-release elements makes it possible to achieve the targeted release of a drug in the ileum or colon” (see, e.g., Talaei, pg. 715, section 3.1.2), and the use of nanoparticles that are capable of adhering to the walls of the small intestine for improved oral delivery and bioavailability; thereby, allowing for “selective delivery to the small intestine” (see, e.g., Friend, pg. 373, “Technology). Therefore, modified-Rabovsky-Simon-Besten-Talaei-Friend teach a enterically-coated pill and a particle capable of targeting the colon and small intestine (i.e., duodenum), respectively.
However, modified-Rabovsky-Simon-Besten-Talaei-Friend does not teach wherein the unit dosage form comprises 1440 mg of bromelain and 288 mg menthol target to the small intestine, and 1200 mg butyric acid (sodium salt), 1800 mg of L-threonine and 0.025mg of Vitamin D3 targeted to the colon (claim 50).
Brien’s general disclosure relates to the use of bromelain as an anti-inflammatory and analgesic for the treatment of osteoarthritis (see, e.g., Brien, abstract). Additionally, Brien teaches the efficacy and optimum dosage for bromelain (see, e.g., Brien, abstract). Moreover, Brien discloses “Bromelain is a food supplement that may provide an alternative treatment to NSAIDs for patients with osteoarthritis. Bromelain is a crude, aqueous extract obtained from both the stem and fruit of the pineapple plant, which contains a number of proteolytic enzymes (10,11) and has shown potentially beneficial effects due to its anti-inflammatory and analgesic properties. Currently, bromelain is used for acute inflammation and sports injuries” (see, e.g., Brien, “Bromelain, pg. 251).
Regarding claims 50 pertaining to the amount of bromelain, Brien teaches “bromelain has been used in the daily dosage range of 200–2000 mg” (see, e.g., Brien, pg. 256, “Dosage in Human Studies”).
Pedrani’s general disclosure relates to “modified-release compositions containing menthol” (see, e.g., Pedrani, [0001]) or the treatment of intestinal disorders or inflammatory, immunological, and/or systemic origin (see, e.g., Pedrani, [0003]). Moreover, Pedrani discloses “presents a marked spasmolytic effect attributable to the following action mechanisms: inhibition of the Ca2+ channels present on the smooth muscle cells, which are involved in the contraction mechanism; colonic activation of the TRPM8 (Transient Receptor Potential Channel) receptors which induce a lasting relaxation effect on the colon muscles (known as cold receptors); inhibition of the TRPA1 receptors, which induce proximal and distal contraction of the colon” (see, e.g., Pedrani, [0005]-[0007]).
Regarding claim 50 pertaining to the amount of menthol, Pedrani teaches a composition comprising of “10 and 1200 mg of menthol, preferably 50-200 mg of menthol” (see, e.g., Pedrani, [0022]).
Spector’s general disclosure relates to “compositions and methods that include short chain fatty acids (SCFAs) related to therapeutic compounds” (see, e.g., Spector, abstract) for the treatment and prevention of diseases and disorders, such as “autoimmune-mediated gastrointestinal diseases” (see, e.g., Spector, [0065]). Moreover, Spector discloses “SCFAs are important regulators of inflammation by controlling migration of immune cells toward inflammatory sites as well as modulating their activation state. Importantly, SCFAs influence the balance between pro- and anti-inflammatory cells and serve as a means of communication between microbiota and the immune system. The principle mechanisms through which SCFAs exert anti-inflammatory effects are suppression of TNFα and NF-κB activation, the inhibition of IFN-γ production, and upregulation of the peroxisome proliferator-activated receptor γ (PPARγ, a nuclear hormone receptor capable to inhibit NF-κB dependent transcriptional activation” (see, e.g., Spector, [0004]).
Regarding claim 50 pertaining to the amount of butyric acid and sodium butyrate, Spector teaches that the daily dose of butyric acid is 900 or 1800 mg butyric acid (see, e.g., Spector, [0363]). Furthermore, Spector teaches a salt of butyric acid may be sodium butyrate (see, e.g., Spector, [0106]).
Grish’s general disclosure relates to a therapeutic composition with anti-inflammatory and immune modulatory effects (see, e.g., Grish, [0011]) for the treatment of diseases, such as Crohn’s Disease (see, e.g., Grish, [0013]).
Regarding claim 50 pertaining to the amount of L-threonine, Girsh teaches the amount of L-threonine within the composition is “about 0.5 to about 12.5 grams” (see, e.g., Girsh, [0371]).
Holstein’s general disclosure relates to “formulations, kits and methods useful for treating, preventing, supporting, controlling, restoring, and/or maintaining blood sugar levels in individuals with type II diabetes or at risk of developing the same” (see, e.g., Holstein, abstract). Furthermore, Holstein teaches a composition that comprises bromelain, SCFAs, amino acids, and vitamins (see, e.g., Holstein, [0016], [0018]).
Regarding claim 50 pertaining to the amount of vitamin D, Holstein teaches 1000 IU of vitamin D (see, e.g., Holstein, pg. 24, Table C), which is equivalent to 0.025 mg of vitamin D.
It would have been obvious to combine the various supplement formulation components, taught by modified-Rabovsky-Simon-Besten-Talaei-Friend, with the amounts of each component within an oral dosage form, as taught by Brien, Pedrani, Spector, Girsh, and Holstein. One would have been motivated to do so to produce an oral dosage form, with specific amounts of each component, as taught by modified-Rabovsky-Simon-Besten-Talaei-Friend, for targeted delivery to the colon or duodenum for the treatment of GI diseases and disorders, as taught by as taught by Brien, Pedrani, Spector, Girsh, and Holstein. Moreover, modified-Rabovsky-Simon-Besten-Talaei-Friend teach a tablet (see, e.g., Talaei, pg. 716, section 3.2) that contains “a combination of enteric coating and delayed-release elements makes it possible to achieve the targeted release of a drug in the ileum or colon” (see, e.g., Talaei, pg. 715, section 3.1.2), and the use of nanoparticles that are capable of adhering to the walls of the small intestine for improved oral delivery and bioavailability; thereby, allowing for “selective delivery to the small intestine” (see, e.g., Friend, pg. 373, “Technology). Additionally, Brien, Pedrani, Spector, Girsh, and Holstein each teach the dosages of the composition components for treatment of various diseases or disorders. Therefore, since modified-Rabovsky-Besten-Talaei-Friend and Brien, Pedrani, Spector, Girsh, and Holstein all teach the same composition components for targeted delivery to the GI tract, it would have been obvious to apply these targeted compositions for treatment of various GI diseases/disorders. One would have expected success since modified-Rabovsky-Simon-Besten-Talaei-Friend and Brien, Pedrani, Spector, Girsh, and Holstein all teach compositions and treatments for inflammatory diseases.
Regarding claim 50’s concentration limitations, those working in the biological and/or pharmaceutical arts would understand that the adjustments of particular conventional working conditions (e.g., concentration or amount of a compound) is deemed a matter of judicious selection and routine optimization, which is in the purview of the skilled artisan (see, e.g., MPEP 2144.05). For example, Brien teaches that bromelain has anti-inflammatory properties (see, e.g., Brien, “Bromelain, pg. 251). And that daily dosage range of bromelain is 200–2000 mg (see, e.g., Brien, pg. 256, “Dosage in Human Studies”). Pedrani teaches that menthol relaxes colon muscles and can be used in compositions for treatment of intestinal disorders or inflammatory, immunological, and/or systemic origin (see, e.g., Pedrani, [0003]-[0007]). Furthermore, Pedrani teaches compositions comprising “10 and 1200 mg of menthol, preferably 50-200 mg of menthol” (see, e.g., Pedrani, [0022]). Spector teaches compositions comprising SCFAs for the treatment of inflammatory diseases, such as gastrointestinal diseases (see, e.g., Spector, abstract & [0065]), wherein butyric acid, a SCFA, is used in a composition at an amount of 900 or 1800 mg (see, e.g., Spector, [0363]). Moreover, Spector states “it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention” (see, e.g., [0444]). Girsh teaches “Formulations of the composition can be readily made by those of ordinary skill in the art using standard techniques” (see, e.g., Girsh, [0385] and “One skilled in the art can readily determine an effective amount of the composition to be administered to a patient” (see, e.g., Girsh, [0391]). Holstein teaches compositions comprising bromelain, SCFAs, amino acids, and vitamins (see, e.g., Holstein, [0016], [0018]) and states “While various embodiments of the invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention” (see, e.g., Holstein, [0050]). This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning these concentrations, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variables which can be met as a matter of routine optimization.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Rabovsky (US2016/0193306; Date of Publication: July 7, 2016 – previously cited) in view of Talaei (Overcoming Therapeutic Obstacles in Inflammatory Bowel Diseases: A Comprehensive Review on Novel Drug Delivery Strategies, 2013 – previously cited), Friend (Drug Delivery to the Small Intestine, 2004 – previously cited), Brien (Bromelain as a Treatment for Osteoarthritis: A Review of Clinical Studies, 2004 – previously cited), Pedrani (US2018/0133166; Date of Publication: May 17, 2018 previously cited), Spector (US2018/0214399; Date of Publication: August 2, 2018 – previously cited), Girsh (US2009/0274660; Date of Publication: November 5, 2009 – previously cited), and Holstein (US2016/0235822; Date of Publication: August 18, 2016 – cited in the IDS filed 10/12/2022 – previously cited).
Rabovsky’s general disclosure is discussed above.
Regarding claim 51 pertaining to the dosage compositions, Rabovsky teaches supplement formulations comprising bromelain (see, e.g., Rabovsky, [0023]-[0026]), fatty acids (see, e.g., Rabovsky, [0273]), natural amino acids selected from the group consisting of “L-alanine, L-arginine, L-asparagine, L-aspartic acid, L-cysteine, L-glutamic acid, L-glutamine, L-glycine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, L-valine” (see, e.g., Rabovsky, [0173]), and vitamin D3 (see, e.g., Rabovsky, [0040]).
However, Rabovsky does not teach: Type A and Type B pills, tablets, minitabs, granules, capsules, particles or microparticles, wherein the Type A pills, tablets, minitabs, granules, capsules, particles or microparticles consist essentially of 720 mg of bromelain and are formulated for release of the bromelain to the small intestine of a subject, and the Type A pills, tablets, minitabs, granules, capsules, particles or microparticles optionally comprise 144 mg menthol, and the Type B pills, tablets, minitabs, granules, capsules, particles or microparticles consist essentially of 600 mg sodium butyrate, 900 mg L-threonine, L-tryptophan, L-glutamine, L-arginine or L-methionine or any combination thereof, and 0.0125 mg Vitamin D and are formulated for release of the sodium butyrate, L-threonine, L-tryptophan, L-glutamine, L-arginine or L-methionine or any combination thereof, and Vitamin D to the lower intestine of a subject (claim 51).
Talaei’s general disclosure is discussed above.
Regarding claim 51 pertaining to oral dosage forms formulated to release its contents to the small intestine, Talaei teaches a tablet (see, e.g., Talaei, pg. 716, section 3.2) that contains “a combination of enteric coating and delayed-release elements makes it possible to achieve the targeted release of a drug in the ileum or colon” (see, e.g., Talaei, pg. 715, section 3.1.2).
Friend’s general disclosure is discussed above.
Regarding claim 51 pertaining to oral dosage forms formulated to release its contents into the lower intestine, Friend teaches “most oral dosage forms (tablets, capsules, liquids, and so on) are normally formulated to release or deliver the active agent (drug) in the small intestine (see, e.g., Friend, pg. 371, introduction). Moreover, Friend teaches the use of nanoparticles that are capable of adhering to the walls of the small intestine for improved oral delivery and bioavailability; thereby, allowing for “selective delivery to the small intestine” (see, e.g., Friend, pg. 373, “Technology).
Brien’s general disclosure is discussed above.
Regarding claim 51 pertaining to the amount of bromelain, Brien teaches “bromelain has been used in the daily dosage range of 200–2000 mg” (see, e.g., Brien, pg. 256, “Dosage in Human Studies”).
Spector’s general disclosure is discussed above.
Regarding claim 51 pertaining to the amount of butyric acid and sodium butyrate, Spector teaches that the daily dose of butyric acid is 900 or 1800 mg butyric acid (see, e.g., Spector, [0363]). Furthermore, Spector teaches a salt of butyric acid may be sodium butyrate (see, e.g., Spector, [0106]).
Grish’s general disclosure is discussed above.
Regarding claim 51 pertaining to the amount of L-threonine, Girsh teaches the amount of L-threonine within the composition is “about 0.5 to about 12.5 grams” (see, e.g., Girsh, [0371]).
Holstein’s general disclosure is discussed above.
Regarding claim 51 pertaining to the amount of vitamin D, Holstein teaches 1000 IU of vitamin D (see, e.g., Holstein, pg. 24, Table C), which is equivalent to 0.025 mg of vitamin D.
It would have been obvious to combine the various supplement formulation components, taught by modified-Rabovsky-Simon-Besten-Talaei-Friend, with the amounts of each component within an oral dosage form, as taught by Brien, Pedrani, Spector, Girsh, and Holstein. One would have been motivated to do so to produce an oral dosage form, with specific amounts of each component, as taught by modified-Rabovsky-Simon-Besten-Talaei-Friend, for targeted delivery to the colon or duodenum for the treatment of GI diseases and disorders, as taught by as taught by Brien, Pedrani, Spector, Girsh, and Holstein. Moreover, modified-Rabovsky-Simon-Besten-Talaei-Friend teach a tablet (see, e.g., Talaei, pg. 716, section 3.2) that contains “a combination of enteric coating and delayed-release elements makes it possible to achieve the targeted release of a drug in the ileum or colon” (see, e.g., Talaei, pg. 715, section 3.1.2), and the use of nanoparticles that are capable of adhering to the walls of the small intestine for improved oral delivery and bioavailability; thereby, allowing for “selective delivery to the small intestine” (see, e.g., Friend, pg. 373, “Technology). Additionally, Brien, Pedrani, Spector, Girsh, and Holstein each teach the dosages of the composition components for treatment of various diseases or disorders. Therefore, since modified-Rabovsky-Besten-Talaei-Friend and Brien, Pedrani, Spector, Girsh, and Holstein all teach the same composition components for targeted delivery to the GI tract, it would have been obvious to apply these targeted compositions for treatment of various GI diseases/disorders. One would have expected success since modified-Rabovsky-Simon-Besten-Talaei-Friend and Brien, Pedrani, Spector, Girsh, and Holstein all teach compositions and treatments for inflammatory diseases.
Regarding claim 51’s concentration limitations, as discussed above, those working in the biological and/or pharmaceutical arts would understand that the adjustments of particular conventional working conditions (e.g., concentration or amount of a compound) is deemed a matter of judicious selection and routine optimization, which is in the purview of the skilled artisan (see, e.g., MPEP 2144.05). For example, Brien teaches that bromelain has anti-inflammatory properties (see, e.g., Brien, “Bromelain, pg. 251). And that daily dosage range of bromelain is 200–2000 mg (see, e.g., Brien, pg. 256, “Dosage in Human Studies”). Pedrani teaches that menthol relaxes colon muscles and can be used in compositions for treatment of intestinal disorders or inflammatory, immunological, and/or systemic origin (see, e.g., Pedrani, [0003]-[0007]). Furthermore, Pedrani teaches compositions comprising “10 and 1200 mg of menthol, preferably 50-200 mg of menthol” (see, e.g., Pedrani, [0022]). Spector teaches compositions comprising SCFAs for the treatment of inflammatory diseases, such as gastrointestinal diseases (see, e.g., Spector, abstract & [0065]), wherein butyric acid, a SCFA, is used in a composition at an amount of 900 or 1800 mg (see, e.g., Spector, [0363]). Moreover, Spector states “it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention” (see, e.g., [0444]). Girsh teaches “Formulations of the composition can be readily made by those of ordinary skill in the art using standard techniques” (see, e.g., Girsh, [0385] and “One skilled in the art can readily determine an effective amount of the composition to be administered to a patient” (see, e.g., Girsh, [0391]). Holstein teaches compositions comprising bromelain, SCFAs, amino acids, and vitamins (see, e.g., Holstein, [0016], [0018]) and states “While various embodiments of the invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention” (see, e.g., Holstein, [0050]). This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning these concentrations, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variables which can be met as a matter of routine optimization.
Examiner’s Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments pertaining to the teachings of Rabovsky and Besten (remarks, pages 9-15), these arguments are not persuasive for multiple reasons:
First, pertaining to Applicant’s argument pertaining to none of the art teaching a reduction in IL-8 secretion, this is not persuasive because, as discussed above, the combined prior art of Rabovsky, Simon, and Besten teaches the same composition comprising bromelain, one or more SCFAs, one or more amino acids, and vitamin D, which would inherently lead to the same effect of reducing IL-8 secretion since the inherent properties exhibited by the composition would be present (see, e.g., MPEP 2112.02).
Secondly, pertaining to Applicant’s argument regarding Rabovsky being silent on gastrointestinal health, this argument is not persuasive because Applicant’s preamble reciting “A gastrointestinal reprogramming composition for improving a parameter associate with a gastrointestinal disorder” is considered intended use and does not limit the structure of independent claim 1 (see, e.g., MPEP 2111.02). Therefore, claim 1 is presumed satisfied by the structurally complete invention recited within the body of independent claim 1. The broadest reasonable interpretation (BRI) of independent claim 1 is a composition comprising bromelain, one or more SCFA, one or more amino acid, and vitamin D or alfacalcidiol. Therefore, based on the BRI of claim 1, the combined prior art of Rabovsky, Simon, and Besten teaches the instantly claimed invention, which would inherently have gastrointestinal reprogramming capabilities and improve a parameter associated with a gastrointestinal disorder. Therefore, it is not necessary that Rabovsky teach a gastrointestinal composition because this is inherent based on the BRI of independent claim 1.
Thirdly, pertaining to Applicant’s argument regarding the teachings of Besten, this argument is moot because Simon was used in this current office action to teach SCFAs and Besten was cited as motivation to use SCFAs in gastrointestinal compositions. Furthermore, Rabovsky does indeed teach compositions comprising fatty acids (see, e.g., Rabovsky, [0273]); therefore, based on the teachings of Simon and Besten, as discussed above, it would have been obvious to substitute fatty acids for SCFAs because SCFAs play an important end product of fermentation of dietary fibers by anaerobic intestinal microbiota (see, e.g., Besten, pg. 2325, abstract) and suggests that it “might play a key role in the prevention and treatment of the metabolic syndrome, bowel disorders, and certain types of cancer” (see, e.g., Besten, pg. 2326, introduction). Therefore, there is motivation to substitute fatty acids, as taught by Rabovsky, for SCFAs as taught by Simon and Besten.
Fourthly, pertaining to Applicant’s arguments regarding unexpected results, this argument is not persuasive because Applicant’s results are not commensurate in scope with the claimed invention (see, e.g., MPEP 716.02(d)). Applicant is relying on a human colorectal adenocarcinoma cell-line C2BB1 grown in DMEM supplemented with 10% FBS, 4 mM L-glutamine, 100 U/ml penicillin and 100 mg/mL streptomycin (see, e.g., instant Specification, Example 8). Furthermore, Applicant is relying on a specific concentration of Caco-2 cells seeded onto transwells (5x105 cell/well), as well as the addition of IFN (50 ng/ml), LPS (10 µg/ml), and TNF (5 ng/ml). Additionally, within Example 8 of the instant specification, Applicant is relying on the addition of 80 µg/ml of bromelain to the formulation. None of these cell types, growth methods, growth media, media components, or concentrations were claimed; therefore, the results are not commensurate in scope with the claimed invention.
Regarding Applicant’s arguments pertaining to the teachings of Rabovsky, Besten, and Simon (remarks, page 15), this argument is not persuasive because, as discussed above, the Examiner relied on Simon to teach SCFAs. Furthermore, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding Applicant’s argument pertaining to the teachings of Brien (remarks, page 16), this argument is not persuasive because Brien teaches bromelain is a crude, aqueous extract obtained from both the stem and fruit of the pineapple plant, which contains a number of proteolytic enzymes (10,11) and has shown potentially beneficial effects due to its anti-inflammatory and analgesic properties. Currently, bromelain is used for acute inflammation and sports injuries” (see, e.g., Brien, “Bromelain, pg. 251). Furthermore, Applicant is claiming and stating that their composition can reduce IL-8 secretion and IL-8 is a pro-inflammatory cytokine (see, e.g., Art of Record, Meniailo); therefore, since Brien teaches that bromelain is anti-inflammatory, it would be obvious to produce a composition with bromelain in order to reduce inflammation caused by IL-8. Furthermore, as discussed above, the BRI of independent claim 1 is a composition comprising bromelain, one or more SCFA, one or more amino acid, and vitamin D or alfacalcidiol. Applicant’s recitation of a “gastrointestinal reprogramming composition” is considered inherent.
Conclusion
Claims 1, 16-17, 19, 21-22, 24, 27, 30, 33, 36, 38-42, 45, 50-51, and 54-55 are rejected.
No claims are allowed.
Art of Record
Meniailo ME, Malashchenko VV, Shmarov VA, Gazatova ND, Melashchenko OB, Goncharov AG, Seledtsova GV, Seledtsov VI. Interleukin-8 favors pro-inflammatory activity of human monocytes/macrophages. Int Immunopharmacol. 2018 Mar;56:217-221. doi: 10.1016/j.intimp.2018.01.036. Epub 2018 Feb 3. PMID: 29414654.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATALIE IANNUZO/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653