DETAILED ACTION
Status of the Claims
Claims 1-8 are pending in the instant application and are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant Application is a Continuation Application of U.S. Application No. 18/366,927 filed 08/08/2023, which was a Continuation of 16/673,083 filed 11/04/2019 which was a Continuation of 16/128,349 filed 09/11/2018 which claims priority to U.S. Provisional Application No. 62/696,955 filed 07/12/2018.
The U.S. effective filing date has been determined to be 11/04/2019, the filing date of the parent application 16/673,083. Applicant's claim for a priority date of, 07/12/2018, the subject matter of the instant claims was introduced in the original claims of 16/673,083. Particularly, instant claim 1 recites, in part, that "one or both of a natural or artificial sweetener in an amount of 1 mg to 5 grams per serving, a salt in an amount of 5-200 mg per serving; and a pharmaceutical agent in an amount of 0.001-3,000 mg per serving." which amounts are not described in 16/128,349 or 62/969,955. Additionally, the limitations "powdered isomalto-oligosaccharide (IMO) [ ... ] , powdered honey, [ ... ] , glucose syrup, [ ... ] , coconut sugar, [ ... ] , raw can sugar, [ ... ], turbinado syrup, allulose syrup, [ ... ], powdered inulin, fibrosol, maltodextrin, dextrin, gumarabic, dextrose anhydrous, dextrose monohydrate, dried glucose syrup, sorghum syrup, tagatose syrup [ ... ] , erythritol syrup, mannitol syrup, sorbitol syrup, xylitol syrup, ethylene glycol, glycerol [ ... ], threitol, arabitol [ ... ], ribitol, mannitol, sorbitol, galactitol, fucitol, iditol, and inositol [ ... ] saccharin, acesulfame, aspartame, neotame, and sucralose." (claim 4, lines 3-15) are not described in 16/128,349 or 62/969,955. Additionally, "sugarcane syrup" and "cane sugar syrup" are being interpreted as synonymous where the former is supported in 62/969,955 (p. 6, line 17). The subject matter of claim 5 is not disclosed prior to original claims filed of the parent application 16/673,083.
Information Disclosure Statement
The information disclosure statement submitted on 12/05/2024 was filed before the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(l) and MPEP § 608.01(o). Correction of the following is required: instant claim 1 recites “one or both of a natural or artificial sweetener in an amount of 1 mg to 5 grams per serving, a salt in
an amount of 5-200 mg per serving; and a pharmaceutical agent in an amount of 0.001-30,00 mg per serving” (claim 1, lines 3-6), limitations that do not find antecedent basis in the Specification.
Claim Objections
Claims 2-4 are objected to because of the following informalities: Instant claim 1 recites "soy or sunflower lecithin" and "palm oil" an required elements, and claims 2-4 repeat these elements that are already required, therefore the recitation of these elements in dependent claim are redundant and should be amended/delete. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites amounts of “one or both of a natural or artificial sweetener” “a salt” and “a pharmaceutical agent” in amounts relative to a serving (i.e. “per serving”), however the claim does not define what exactly a serving should be considered and it is therefore unclear what the claimed amount should be considered. Appropriate clarification is required. Claims 2-8 are rejected as inheriting and doing nothing to clarify the above discussed issue with claim 1.
Claim 3 is rejected as being indefinite because the claim recites the transitional phrase “comprises” with alternatives “isomalto-oligosaccharide (IMO) syrup, palm oil, citric acid and/or malic acid and/or tartaric acid and/or fumaric acid, and soy or sunflower lecithin and salt.” MPEP §2111.03(I) makes clear that: “‘Comprising’ is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim” The use of and/or (as emphasized above) renders the claim indefinite because it is unclear what exactly the claimed essential elements are. Appropriate clarification is required.
Claim 4 is rejected as being indefinite because the claim recites: "the saccharide base comprises one or more saccharides from the group of saccharides selected from the group consisting of: tapioca syrup, isomalto oligosaccharide (IMO) syrup, [...], sorghum syrup, tagatose syrup, and the following sugar alcohols: erythritol syrup, mannitol syrup, sorbitol syrup, or xylitol syrup, ethylene glycol, glycerol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, iditol, and inositol combined with any combination of the following: palm oil, coconut oil, citric acid, malic acid, fumaric acid, tartaric acid, soy and/or sunflower lecithin, stevia (leaf) extract, monk fruit extract, saccharin, acesulfame, aspartame, neotame, and sucralose." [emphasis added] where it is not clear (1) if Applicants intend the claim to open-ended (i.e. “comprising”) or a closed grouping of alternatives (i.e. “selected from the group consisting of”)( MPEP §2111.03) and (2) the first grouping of “saccharides” lacks a proper conjunction between the last two elements “sorghum syrup, tagatose syrup” (line 9) but rather Applicants claim creates a run-on group of “sugar alcohols” and another of “inositol combined with any combination of the following:” Therefore, it is unclear what exactly what claim elements are required by claim 4 for the oral mucoadhesive delivery system of claim 1. Appropriate clarification is required.
Claim 4 is further rejected as being indefinite for reciting a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation stevia extract, and the claim also recites stevia leaf extract (lines 13-14) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Appropriate clarification is required.
Claim 6 is rejected as being indefinite because the claim 6 recites "The oral mucoadhesive delivery system of claim 6 [ ... ]."Andis therefore indefinite because the claim is self-dependent. Appropriate clarification is required. For purposes of examination herein claim 6 is being read to depend from claim 1.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over DAVIS (US 2010/0226904 A1; published September, 2010) in view of WAN (WO 2018/027081 A1; published February, 2018) and NIETLING (US 2015/0086686 A1; published March, 2015).
Applicants Claims
Applicant claims an oral mucoadhesive delivery system for a pharmaceutical agent, comprising a saccharide base, soy or sunflower lecithin, palm oil, one or both of a natural or artificial sweetener in an amount of 1 mg to 5 grams per serving, a salt in an amount of 5-200 mg per serving; and a pharmaceutical agent in an amount of 0.001-3,000 mg per serving (instant claim 1). Applicant further claims the pharmaceutical is acetylsalicylic acid (Aspirin)(instant claim 5). Applicant further claims the oral mucoadhesive delivery system is formed into a soft-chew or a gummy (instant claim 6).
Claim interpretation: The instant Specification discloses that: “In some preferred embodiments, the composition is 100% naturally derived (e.g. plant extracts) with a mucoadhesive, saccharide-base comprised of tapioca syrup, palm oil, non-GMO citric acid and/or malic acid and/or fumaric acid, sunflower lecithin, plant-extracted colors and flavors, and sea salt." (instant claims 1-2), and that: “In some embodiments, the natural (or synthetically-derived) saccharide-base is comprised of isomalto-oligosaccharide (IMO) syrup combined with palm oil and/or coconut oil, citric acid and/or malic acid and/or fumaric acid, soy and/or sunflower lecithin, natural and/or artificial flavors, natural and/or artificial colors, and salt.” ([0008]). Therefore, the claim term “a saccharide base” (claim 1, line 2) is being limited to the extent that the disclose elements of the saccharide base are recited in the claim, that is, soy or sunflower lecithin, palm oil, (claim 1) along with tapioca syrup (claim 2) or isomalto-oligosaccharide (IMO) syrup (claim 3). The preamble term “mucoadhesive” is given weight to the extent that the ingredients in the claim would
have had this function upon oral use.
Determination of the scope
and content of the prior art (MPEP 2141.01)
DAVIS discloses organic chewable supplement (title, see whole document), and particularly that: “An organic chewable composition for delivering dietary supplements and pharmaceutical compounds. The chewable composition includes an organic delivery vehicle and an active ingredient. The delivery vehicle may include an organic gummy candy. The active ingredient may include an over the counter drug or a prescription drug to provide a desired effect on the user. The active
ingredient may also include any combination of nutraceuticals, vitamins, minerals, antioxidants, soluble and insoluble fiber, herbs, plants, amino acids, and digestive enzymes.” (abstract).
DAVIS discloses an Example of a Chewable Drug composition ([0104]-[0111]) including:
PNG
media_image1.png
430
752
media_image1.png
Greyscale
The aspirin being 50 mg per serving (0.5% = 50 mg), the organic sugar (natural sweetener) being 30% (or 3,000 mg= 3 g), and including the saccharide tapioca syrup (46% or 4.6 g)(instant claim 1, saccharide base = tapioca syrup; natural sweetener, amount 3 g; pharmaceutical agent= aspirin (acetylsalicylic acid)= 50 mg - instant claims 1 & 5). With respect to the amount of “a salt in an amount of 5-200 mg per serving,” DAVIS teaches that: “About 0.1 % to 10% sodium bisulfate by weight may be added to the gelling compound to reduce the pH of the gelling compound to about 3.5.” ([0105]) which is 10 mg to 10 grams. MPEP §2144.05-1 makes clear that: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” Therefore, each of (1) the range of sweetener (1 mg to 5,000 mg - claimed; 3,000 mg disclosed), (2) the range of the pharmaceutical agent (aspirin, 0.001-3,000 mg claimed; 50 mg disclosed), and (3) the amount of a salt (sodium bisulfate, 5-200 mg claimed; 10-10,000 mg disclosed), are each prima facie obvious based on values that lie inside the claimed ranges. The formulation is a gummy formulation (instant claim 6). The formulation includes citric acid (instant claim 7).
DAVIS teaches that: "In one implementation, a solvent system containing a filming agent may be mixed with the drug particles and blended at slow speed in a planetary mixer. The solvent may be water or ethanol and the filming agent may be ethylcellulose, gelatin, a water-soluble plasticizer (e.g., glycerin, xylitol, or glucose), or any other suitable composition." [emphasis added]([0086])(instant claim 4, sugar alcohol - xylitol, glycerol syn./w glycerin). DAVIS further teaches the inclusion of the supplement inositol ([0049] & [0099])(instant claim 4, sugar alcohol).
DAVIS teaches that: “Depending on the desired finished product or preferences, the gummies may be polished with fractionated coconut oil, [ ... ].” ([0076]), and that: “As the candies are being tumbled, about 1 % fractionated coconut oil by weight and about 1% carnauba wax by weight may be poured into the drum to coat the candies to prevent them from sticking together.” ([0102] & [0117])(instant claim 4, coconut oil).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of DAVIS is that DAVIS does not expressly teach the inclusion of soy or sunflower lecithin and palm oil (instant claim 1).
NIETLING teaches insoluble fiber compositions (title, see whole document) and particularly that: "The present disclosure relates generally to an insoluble fiber composition. In one embodiment the composition is a soft and chewy confectionery with a high dietary fiber content that includes a greater amount of insoluble fiber than soluble fiber." ([0002]). And that: "While the present composition is primarily intended to be a fiber composition, it is contemplated that embodiments of the invention can include supplements such as, but not limited to, vitamins, minerals, herbs, botanicals, plant derived supplements, animal derived supplements, therapeutic compounds, and mixtures thereof." ([0035]).
NIETLING teaches that: "The compositions of the present invention can be formed into any suitable, ingestible form. Non-limiting examples of the form of the compositions include: soft chew[ ... ]." ([0038]). And that: "Soft chew is intended to mean a product which is solid at room temperature and which are soft to chew and which is functionally chewy because the product has some plastic texture during the process of mastication in the mouth." ([0039]). NIETLING teaches that: “Non-limiting examples of suitable blending agent components include […] lecithin […].” ([0028]), and teaches an example including sunflower lecithin (p. 4, col. 2, Table II, last item). Therefore, it would have been prima facie obvious to select sunflower lecithin as suitable for the intended use of an emulsifier in a soft chew/gummy formulation (instant claim 1, sunflower lecithin). NEITLING further teaches and example including: “Tapioca Syrup-42DE”, “Palm Oil”, “Citric Acid” and “Sunflower Lecithins” ([0055], Table II).
WAN teaches that: “The application relates generally to nutraceutical composition in gelled or gummy formula, methods of administration of various gummy or gelled compositions for nutraceuticals, and kits comprising various gummy compositions for nutraceuticals.” (p. 1, §Technical Field, see whole document).
WAN further teaches that: “In one embodiment, the application provides a nutraceutical composition comprising a neuroprotecting composition, an anti-inflammatory composition, a cardiovascular protecting composition, an anti oxidant composition, and a gelling component in a sufficient amount to provide a cohesive gelled product.” (p. 5, last paragraph). And that: “The anti-inflammatory composition includes agent that is capable of reduce or attenuate inflammation. In one embodiment, the anti-inflammatory composition comprises acetylsalicylic acid [...]." (p. 7, §Anti-inflammatory composition, paragraphs 1-2). WAN further teaches the inclusion of Fibers and prebiotics including inulin (p. 14, §Fibers and prebiotics, paragraphs 1-2).
WAN teaches the inclusion of plasticizer including sugar alcohols such as sorbitol, xylitol, mannitol, glactitol, maltitol, erythritol, among others (p. 22, §Plasticizer). WAN teaches the inclusion of Fats and oils such as palm (kernel) oil, among others, and particularly that: “This edible oil component makes up part of the group of ingredients that adjust the taste, texture, and improve the melt and mouth feel of the flavored chewy or gummy confection.” (pp. 22-23, §Fats and oils). WAN teaches the inclusion of emulsifiers such as lecithin, and particularly that: “The emulsifier may assist in holding together the fats and water and other components together in a homogeneous composition. In one embodiment, the emulsifier may assist in the formation of a ‘water and oil’ emulsion that creates the smooth texture of the finished product.” (p. 24, §Emulsifiers)(instant claim 1, palm oil).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce an organic chewable (gummy) composition for delivering dietary supplements and pharmaceutical compounds such as Aspirin, as suggested by DAVIS, and further to include palm oil to adjust the taste, texture, and improve the melt and mouth feel of the flavored chewy or gummy confection, and lecithin to assist in holding together the fats and water and other components together in a homogeneous composition such as in the formation of a "water and oil" emulsion that creates the smooth texture of the finished product, as suggested by WAN, and further to select sunflower lecithin, as suitable for intended use in a soft chew/gummy as suggested by NIETLING.
One skilled in the art would have been motivated to do so because it is generally considered to be prima facie obvious to combine compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a composition that is to be used for an identical purpose. The motivation for combining them flows from their having been used individually in the prior art, and from the being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the combination of conventional components of gummy or soft-chew pharmaceutical agent delivery compositions. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Kerkhoven, 626 F.2d 848, 205 USPQ 1069 (CCPA 1980).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over DAVIS in view of WAN and NIETLING as applied to claims 1-2 and 4-7 above, and further in view of DOHERTY (US 2018/0185397; published July, 2018) and DIXIT (US 2018/0169008; published June, 2018).
Applicants Claims
Applicant claims an oral mucoadhesive delivery system for a pharmaceutical agent, comprising a saccharide base, soy or sunflower lecithin, palm oil, one or both of a natural or artificial sweetener in an amount of 1 mg to 5 grams per serving, a salt in an amount of 5-200 mg per serving; and a pharmaceutical agent in an amount of 0.001-3,000 mg per serving (instant claim 1). And further claims the oral mucoadhesive delivery system comprises isomalto-oligosaccharide (IMO) syrup, palm oil, citric acid, and/or malic acid and/or tartaric acid and/or fumaric acid, and soy or sunflower lecithin, and salt (instant claim 3).
Claim interpretation: The examiner is reading “and salt.” in line 4 of claim 3 to require any amount of sodium chloride (i.e. table salt).
Determination of the scope
and content of the prior art (MPEP 2141.01)
DAVIS teaches/discloses organic chewable composition including a pharmaceutical agent, as discussed above and incorporated herein by reference.
WAN teaches gummy formulation including various ingredients such as aspirin, as discussed above and incorporated herein by reference. WAN further teaches that: “In one embodiment, the chelates are amino acid chelates.” (p. 3, 2nd full paragraph, last line).
NIETLING teaches insoluble fiber compositions, and particularly soft chew formulations of the same, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of DAVIS et al. is that DAVIS et al. do not expressly teach the inclusion of isomalto-oligosaccharide (IMO) syrup or salt (i.e. sodium chloride)(instant claim 3).
DOHERTY teaches isomalto-oligosaccharide prebiotic formulation (title, see whole document), and particularly that: "The present invention relates to specific formulations of functional foods and nutraceuticals comprising probiotics and Isomalto-oligosaccharides in a tasty "gummy" dosage form. Embodiments of the invention provide relief from the unpleasant side effects of high fiber functional foods and nutraceuticals including stomach discomfort, flatulence, stomach rumbling/belching and overall gut feeling." (abstract).
DOHERTY teaches that: “Isomalto-oligosaccharide (‘IMO’) is a naturally occurring, plant-based dietary fiber. It is prebiotic, soluble, and low-glycemic. Fermentation of IMO by colonic bacteria results in production of Short Chain Fatty Acids (SCFA) that metabolize in liver and are thought to confer many physiological benefits to the host including: protection from colonic cancer, stabilize blood glucose levels, decrease cholesterol synthesis, lowering the digestive tracts pH which allows for an increase absorption of dietary minerals and help stimulate the immune function.” ([0002]). And that: “Isomalto-oligosaccharides belong to a group of oligosaccharides classified as functional-health food oligosaccharides and include fructo-oligosaccharides, galactooligosaccharides, xylo-oligosaccharides and gentiooligosaccharides. IMO's have been linked to the increase in general well being when taken orally on a regular daily basis and are called ‘probiotics’.” ([0007]).
DOHERTY teaches that: “Isomalto-oligosaccharides can be obtained in different ways. For example, glucose syrups at high dry solids concentration i.e. 60-80% are treated with glucoamylase resulting in the formation of isomalto-oligosaccharides. Other examples are maltose transfer achieved by addition of pullulanase to liquefied starch, branching of maltose syrups and treatment of sucrose with dextran sucrase. See U.S. Pat. No. 6,025,168.” ([0010]).
DOHERTY teaches that: “The present invention relates to specific formulations and methods related to functional foods and nutraceuticals comprising probiotics and Isomalto-oligosaccharides in a tasty ‘gummy’ dosage form (referred to herein as ‘IMO/PRO Gummies’). Embodiments of the invention provide relief from the unpleasant side effects of high fiber functional foods and nutraceuticals including stomach discomfort, flatulence, stomach rumbling/belching and overall gut feeling." ([0030]).
DOHERTY teaches Example 4 - Gummy Clinical Trial: “The objective of this trial was to assess the measurable physiological effects between two separate gummy fiber formulations. The fiber comparison is an embodiment of the instant invention comprising Isomaltooligosaccharide (IMO) versus Inulin, both of which are soluble fibers.” ([0073]). DOHERTY teaches that: “This study demonstrated that the ingestion of IMO fibre and probiotics according to the invention is associated with less dietary side effects in comparison to Inulin.” ([0095]). And that: “Surprisingly, improvements were also noted for the embodiment of the invention in stomach rumbling/bloating and overall gut feeling.” ([0096]).
DIXIT teaches a soft chew pharmaceutical formulations (see whole document), including salt (e.g. sodium chloride) ([0055]).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce an organic chewable (gummy) composition for delivering dietary supplements and pharmaceutical compounds such as Aspirin, as suggested discussed above, and further to include a fiber component in a soft chew/gummy formulation as suggested by DAVIS (abstract, [0013] & [0019]) such as inulin, as suggested by WAN (p. 14, §Fibers and prebiotics, paragraphs 1-2) and NIETLING (see whole document, and particularly p. 4, Examples - Tables I & II), which would have been substituted and/or combined with IMO per the teachings of DOHERTY as reducing side effects of high fiber functional foods and nutraceuticals including stomach discomfort, flatulence, stomach rumbling/belching and overall gut feeling, and further to include salt (sodium chloride) as suggested by DIXIT as a diluent and for improved taste and/or as a mineral component (see WAN - p. 3, 2nd full paragraph, line 3).
One skilled in the art would have been motivated to do so because it is generally considered to be prima facie obvious to combine compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a composition that is to be used for an identical purpose. The motivation for combining them flows from their having been used individually in the prior art, and from the being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the combination of conventional components of gummy or soft-chew pharmaceutical agent delivery compositions. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Kerkhoven, 626 F.2d 848, 205 USPQ 1069 (CCPA 1980).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over DAVIS in view of WAN and NIETLING as applied to claims 1-2 and 4-7 above, and further in view of HENDERSON (US 7,153,503 B1; published December, 2006).
Applicants Claims
Applicant claims an oral mucoadhesive delivery system for a pharmaceutical agent, comprising a saccharide base, soy or sunflower lecithin, palm oil, one or both of a natural or artificial sweetener in an amount of 1 mg to 5 grams per serving, a salt in an amount of 5-200 mg per serving; and a pharmaceutical agent in an amount of 0.001-3,000 mg per serving (instant claim 1). Applicant further claims the mucoadhesive delivery system also comprising a chelating compound selected from the group of chelating compounds consisting of: succinic acid, ascorbic acid, aspartic acid, threonic acid, lysinic acid, orotic acid, malic acid, tauric acid, citric acid, and gluconic acid (instant claim 7). And further that: the chelating compound is from the group of chelating compounds consisting of: aspartate, amino acid chelate, glycinate, methionine, and cysteine ( claim 8).
Determination of the scope
and content of the prior art (MPEP 2141.01)
DAVIS teaches/discloses organic chewable composition including a pharmaceutical agent, as discussed above and incorporated herein by reference.
WAN teaches gummy formulation including various ingredients such as aspirin, as discussed above and incorporated herein by reference. WAN further teaches that: “In one embodiment, the chelates are amino acid chelates.” (p. 3, 2nd full paragraph, last line).
NIETLING teaches insoluble fiber compositions, and particularly soft chew formulations of the same, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of DAVIS et al. is that DAVIS et al. do not expressly teach the inclusion of a specific amino acid chelate or chelating compound (instant claims 7-8).
HENDERSON teaches a comprehensive dietary supplement of bioavailable minerals, vitamins, among others, including minerals as amino acid chelates (see whole document, particularly the abstract).
HENDERSON further teaches that: “studies have found that minerals that are chelated or complexed by amino acids, or combinations of amino acids and vitamin acid ligands, ( e.g. glycinates, arginates, and nicotinate glycinates) are bioavailable forms that render the minerals more readily absorbed by virtue of the fact that transport across the intestinal mucosa and into the portal circulation is accomplished by an amino acid transport mechanism and not by traditional mineral acid transport mechanisms. Once in the blood, the amino acid chelates do not bind directly to serum proteins, but are transported directly to target tissues in the chelated form. Thereafter, the mineral is released intracellularly from the chelate. Importantly, this direct transport results in greatly improved bioavailability of the minerals to the end organs and/or cells and works independent of either mineral saturated or reduced concentrations of serum proteins. Additionally, unlike most conventional mineral salts that are commercially available, amino acid chelates do not cause changes in bowel habits after oral administration. This is in contrast to notable examples of conventional iron salts such as iron sulfate, which may cause constipation, and magnesium citrate which commonly causes loose stools or diarrhea.” ( col. 5, lines 23-44)(instant claims 7-8).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce an organic chewable (gummy) composition for delivering dietary supplements and pharmaceutical compounds such as Aspirin, as suggested discussed above, and further to include minerals chelated or complexed by amino acids (e.g. glycinates) for improved bioavailability, as suggested by HENDERSON, as studies have found that minerals that are chelated or complexed by amino acids, or combinations of amino acids and vitamin acid ligands, (e.g. glycinates, arginates, and nicotinate glycinates) are bioavailable forms that render the minerals more readily absorbed.
One skilled in the art would have been motivated to do so because it is generally considered to be prima facie obvious to combine compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a composition that is to be used for an identical purpose. The motivation for combining them flows from their having been used individually in the prior art, and from the being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the combination of conventional components of gummy or soft-chew pharmaceutical agent delivery compositions. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Kerkhoven, 626 F.2d 848, 205 USPQ 1069 (CCPA 1980).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application Nos. 18/969,591 (claims 1-16, hereafter ‘591); 18/976,609 (claims 1-18, hereafter ‘609); and 17/689,844 (claims 1, 5-28, hereafter ‘844) in view of DAVIS (US 2010/0226904 A1); WAN (WO 2018/027081 A1); NIETLING (US 2015/0086686 A1); DOHERTY (US 2018/0185397); DIXIT (US 2018/0169008) and HENDERSON (US 7,153,503 B1).
The instant claims are discussed above.
Copending ‘591 claim 1recites an oral mucoadhesive delivery system comprising: a plant-derived saccharide base; and a sweetener. And wherein the saccharide base comprises tapioca syrup, palm oil, citric acid, and lecithin (claims 2-3, 12). And “wherein the saccharide base comprises a tapioca syrup, isomalto-oligosaccharide (IMO) syrup, powdered isomaltooligosaccharide (IMO), honey, powdered honey, yacon syrup, agave syrup, corn syrup, glucose syrup, coconut sugar syrup, coconut sugar, date syrup, molasses, rice syrup, sugar cane syrup, raw cane sugar, cane sugar syrup, turbinado syrup, allulose syrup, maltitol syrup, polyglycitol syrup, sugar beet syrup, inulin syrup, powdered inulin, fibrosol, maltodextrin, dextrin, gum arabic, dextrose anhydrous, dextrose monohydrate, dried glucose syrup, sorghum syrup, tagatose syrup, and the following sugar alcohols: erythritol syrup, mannitol syrup, sorbitol syrup, or xylitol syrup, ethylene glycol, glycerol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, iditol, and inositol combined with any combination of the following: palm oil, coconut oil, citric acid, malic acid, fumaric acid, tartaric acid, soy and/or sunflower lecithin, organic stevia (leaf) extract, monk fruit extract, saccharin, acesulfame, aspartame, neotame, or sucralose.” (claim 13). Copending ‘591 also claims the inclusion of a (phyto)cannabinoid (claims 5 & 14).
Copending ‘609 recites a composition comprising hemp oil having a cannabidiol (CBD) content of about between 0.50 and 50.0 milligrams per serving] and magnesium in an amount of about 10-500 milligrams per serving (claim 1). The examiner is regarding CBD in this context as a pharmaceutical agent. Copending ‘609 further claims the inclusion of one or more of tapioca syrup, isomalto-oligosaccharide (IMO) syrup, powdered isomalto-oligosaccharide (IMO), honey, powdered honey, yacon syrup, agave syrup, com syrup, glucose syrup, coconut sugar syrup, coconut sugar, date syrup, molasses, rice syrup, sugar cane syrup, raw cane sugar, cane sugar syrup, turbinado syrup, allulose syrup, maltitol syrup, polyglycitol syrup, sugar beet syrup, inulin syrup, powdered inulin, fibrosol, maltodextrin, dextrin, gum arabic, dextrose anhydrous, dextrose monohydrate, dried glucose syrup, sorghum syrup, tagatose syrup, and the following sugar alcohols: erythritol syrup, mannitol syrup, sorbitol syrup, or xylitol syrup, ethylene glycol, glycerol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, iditol, and inositol combined with any combination of the following: palm oil, coconut oil, citric acid, malic acid, fumaric acid, tartaric acid, soy and/or sunflower lecithin, silicon dioxide, cellulose, stevia (leaf) extract, monk fruit extract, natural or artificial flavors, saccharin, acesulfame, aspartame, neotame, and sucralose (claim 18).
Copending ‘844 claim 1 recites an oral mucoadhesive dosage form comprising: a saccharide base and an active ingredient composition, wherein the saccharide base comprises tapioca syrup, palm oil, and sunflower lecithin, and wherein the oral mucoadhesive dosage form adheres to the oral cavity and provides extended mucoadhesive residence time, in order to maximize oral mucosal, small molecule absorption and achieve a mass range per dosage of 4.5-5.5 grams. And The oral mucoadhesive dosage form of claim 1, wherein the active ingredient composition comprises a pharmaceutical (claim 15)
The difference between the instantly rejected claims and the claims of copending ‘591 is that the claim of copending ‘591 do not expressly claim a pharmaceutical agent, and specifically one recited in claim 5 such as acetylsalicylic acid (aspirin).
The difference between the instantly rejected claims and the claims of copending ‘609 is that the claim of copending ‘609 do not expressly claim a pharmaceutical agent, and specifically one recited in claim 5 such as acetylsalicylic acid (aspirin).
The difference between the instantly rejected claims and the claims of copending ‘844 is that the claim of copending ‘844 do not expressly claim do not expressly claim a pharmaceutical agent, and specifically one recited in claim 5 such as acetylsalicylic acid (aspirin).
DAVIS teaches chewable supplements have been manufactured and sold in the form a gummy candy supplement/pharmaceutical, and including plant-based saccharide base elements pectin and/or starch, as discussed above and incorporated herein by reference.
NIETLING teaches insoluble fiber compositions, and particularly soft chew formulations of the same, as discussed above and incorporated herein by reference.
WAN teaches nutraceutical composition in gelled or gummy formula, methods of administration of various gummy or gelled compositions for nutraceuticals, and kits comprising various gummy compositions for nutraceuticals, as discussed above and incorporated herein by reference.
DOHERTY teaches Isomalto-oligosaccharide ("IMO") as a fiber substitute for inulin, as discussed above and incorporated herein by reference.
DIXIT teaches a soft chew pharmaceutical formulations including salt (e.g. sodium chloride), as discussed above and incorporated herein by reference.
HENDERSON teaches a comprehensive dietary supplement of bioavailable minerals, vitamins, among others, including minerals as amino acid chelates, as discussed above and incorporated herein by reference.
It would have been prima facie obvious before the effective filing date of the claimed invention that the instantly rejected claims are an obvious variant of the claims of copending ‘591, ‘609 and ‘844 because the claims of ‘591, ‘609 and ‘844 each include oral mucoadhesives including a saccharide base and/or the components thereof. The skilled artisan would have been motivated to modify the claims of copending 591, ‘609 and ‘844 and produce the instantly rejected claim because gummy formulations are favorable to some consumers such as children/elderly patients. Furthermore, the skilled artisan would have had a reasonable expectation of success in producing the invention of the instantly rejected claims because gummy formulations are well-known including Vitamin(s), Mineral(s) as well as dietary supplement(s) and pharmaceutical agents, including methods of making the same per the cited prior art.
This is a provisional obviousness-type double patenting rejection.
Conclusion
Claims 1-8 are pending and have been examined on the merits. The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter; and claims 2-4 are objected to. Claims 1-8 are rejected under 35 U.S.C. 112(b); claims 1-8 are rejected under 35 U.S.C. 103; and claims are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application Nos. 18/969,591; 18/976,609 and 17/689,844. No claims allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IVAN A GREENE whose telephone number is (571)270-5868. The examiner can normally be reached M-F, 8-5 PM PST.
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, David Blanchard can be reached on (571) 272-0827. 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.
/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
Prosecution Insights