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 .
Status of the Claims
Claims 1,10-11,17,19-21 and 88-90 are pending and currently under examination.
Information Disclosure Statement
Initialed and dated copies of Applicants’ information disclosure statements (IDS) filed on 01/16/2025 is attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claims 88-90 is objected to because of the following informalities: Claim 88 recites “-20C, 4C, 25C, 30C” in line 3, and recites “40C” in line 5. For consistency, amending the claim to read “-20°C, 4°C, 25°C, 30°C” in line 3, and “40°C” in line 5.
Claim 89 recites “25C” in line 2. For consistency, amending the claim to read “25°C”.
Claim 90 recites “37C” in line 2. For consistency, amending the claim to read “37°C”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1,10-11,17,19-21 and 88-90 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “and a residual solvent content lower than a predetermined amount”. The word “and” renders the claim indefinite because it is unclear whether the sentence ends after the phrase ““and a residual solvent content lower than a predetermined amount” or if the limitations after the phrase “and a residual solvent content lower than a predetermined amount” are optional limitations.
Claim 1 recites “a microparticle” in line 2. This language is indefinite because it is unclear whether the particle preparation comprises a payload component, a polymer component and a microparticle or if the microparticle comprises the payload component and the polymer component. As currently claimed, it appears as though the microparticle is distinct from the payload component, polymer component, residual solvent, and excipients, but from the instant specification it appears that the microparticle is made by combining the ingredients together, therefore the microparticle comprises the claimed ingredients.
Claim 1 recites “microparticle loading is from 45% to 90%” in line 11. This language renders the claim indefinite because it is unclear what microparticle loading means, wherein when the microparticle is made, is 90% of what is added to the solution to make the microparticle now captured inside the particle, or does it mean that the microparticle can comprise from 45 to 90% of the payload component. If 90% of the microparticle is the payload component and the minimum amount of excipient present is 10%, there would be no more space for the residual solvent and the polymer component. Therefore it is unclear what microparticle loading means.
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 10 recites the broad recitation at least 80%, and the claim also recites at least 90% and/or at least 95% 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.
Claim 10 recites “at least 80%, at least 90%, and/or at least 95%” in line 2. The word “and” renders the claim indefinite because it is not clear how the particle preparation can release at least 80% and at least 90% and at least 95% of the payload component.
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 1 recites the broad recitation at most 20%, and the claim also recites at most 15%, at most 10%, and/or at most 5%” 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.
Claim 11 recites “at most 20%, at most 15%, at most 10%, and/or at most 5%” in line 2. The word “and” renders the claim indefinite because it is not clear how the particle preparation can release at most 20% and at most 15% and at most 10%, and at most 5% of the payload component.
Claims 19 and 20 contains the trademark/trade name dryflo. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an excipient and, accordingly, the identification/description is indefinite.
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 88 recites the broad recitation less than 0.3, and the claim also recites less than 0.2 and/or less than 0.1” 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.
Claim 88 recites “less than 0.3, less than 0.2 and/or less than 0.1” in line 2. The word “and” renders the claim indefinite because it is not clear how the particle preparation can maintain water activity of less than 0.3, less than 0.2 and less than 0.1 in a sealed storage environment.
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 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, 10, 11, 17, 21, 88-90 are rejected under 35 U.S.C. 103 as being unpatentable over Jaklenec et al. (US20150164816A1, Published 06/18/2015).
Applicant’s Invention
The claims are drawn to a particle preparation comprising a payload component, a polymer component, and a residual solvent content lower than a predetermined amount, a microparticle, a first excipient component, and a second excipient component, wherein: (i) the payload component comprises a nutraceutical comprising at least one antioxidant, at least one macronutrient, at least one micronutrient, at least one mineral, at least one prebiotic, at least one probiotic, at least one vitamin, or any combination thereof; (ii) the polymer component comprises a pH-responsive polymer component comprising a methacrylate, a polygalactomannan, a polysaccharide, or any combination thereof; (iii) the predetermined amount is in a range-from about 1 ppm to about 5000 ppm; (iv) microparticle loading is from 45% to 90%; (v) first excipient component loading is from 10% to 50%; (vi) second excipient component loading is from 0% to 45%, and wherein the particle preparation is formed by adding at least one of the first excipient component and the second excipient component to the microparticle loading during milling.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1 and 21, Jaklenec teaches a salt formulation comprising: particles comprising one or more therapeutic agents, prophylactic agents, nutraceutical agents (i.e., payload component), diagnostic agents, or combinations thereof, a matrix formed of inert excipient having the particles dispersed therein, a pH-sensitive polymer coating on the outer surface of, or surrounding, the matrix, wherein the polymer coating is resistant to permeation of water into the matrix and provides release of the particles upon exposure to a defined pH, and a coating of one or more salts on the pH-sensitive polymer coating, wherein the formulation is stable up to one hour at 100° C (claim 1). Jaklenec also teaches wherein the particles comprise vitamins, trace minerals, micronutrients, or combinations thereof (i.e., payload component) (claim 2). Jaklenec further teaches the term “microparticles” is also art-recognized, and includes microspheres and microcapsules, as well as structures that may not be readily placed into either of the above two categories, all with dimensions on average of less than about 1000 microns (paragraph [0041]). Jaklenec continues to teach the matrix is coated or encapsulated with one or more pH-sensitive, thermally stable biocompatible polymers (paragraph [0094]), wherein Exemplary polymers include polymethacrylates sold under the tradename EUDRAGIT® and other polysaccharides (paragraph [0097]). Jaklenec also teaches iodine (i.e., micronutrient) was encapsulated at 75.2 ± 8.9% efficiency (i.e., microparticle loading) (paragraphs [0166]). Jaklenec further teaches the particles can be dispersed into a matrix formed of one or more stabilizing materials, such as sugars and/or oils, wherein exemplary sugars include sucrose, trehalose, and carbohydrates such as plant components (i.e., excipients) (paragraph [0088]); wherein example 3 teaches 0.6 mL of nutrient/sugar solutions (1:1 ratio) were crystallized and coated with a 5% (by weight) solution of EUDRAGIT® E PO (“EPO”) in acetone (paragraph [0137]), and example 2 teaches 0.6 mL of a sugar/dye solution (0.5 M trehalose+sucrose) was crystallized in a beaker. The crystallized mixture was coated with 1 mL of a EUDRAGIT® E PO (“EPO”) solution in acetone (paragraph [0129]). The examiner points out that the claim recites the limitation wherein the second excipient component loading is from 0% which reads on the composition not containing a second excipient. The examiner notes that instant claim 1 uses product by process language, wherein the claim recites “wherein the particle preparation is formed by adding at least one of the first excipient component and the second excipient component to the microparticle loading during milling”. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I).
Regarding claims 10-11, Jaklenec teaches in some embodiments, the EUDRAGIT® (i.e., pH-sensitive polymer) dissolves at a pH less than 6, preferably less than 5, 4, or 3, such as 1-3, or 1-2 (paragraph [0098]). Jaklenec also teaches wherein the particles comprise vitamins, trace minerals, micronutrients, or combinations thereof (i.e., payload component) (claim 2), wherein exemplary polymers include polymethacrylates sold under the tradename EUDRAGIT® and other polysaccharides (paragraph [0097]), and the particles can be dispersed into a matrix formed of one or more stabilizing materials, such as sugars and/or oils, wherein exemplary sugars include sucrose, trehalose, and carbohydrates such as plant components (i.e., excipients) (paragraph [0088]). Jaklenec further teaches in a two-hour period, the polymer is dissolved at pH 2 and below. The polymer was insoluble at pH 7.4, 10, and 12 (paragraph [0126]). But Jaklenec does not explicitly disclose wherein the particle preparation is characterized as releasing at least 80%, at least 90%, and/or at least 95% of the payload component within 5 minutes when included in an environment having a pH of less than 5; and wherein the particle preparation is characterized as releasing at most 20%, at most 15%, at most 10%, and/or at most 5% of the payload component after soaking the particle preparation for at least 2 hours in an environment having a pH of 7 and a temperature within a range of 25°C to 100°C. However, such properties must necessarily be present. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. See In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, Bolton, and Shaw, 195 USPQ 430, 433 (CCPA 1977) citing In re Brown, 59 CCPA 1036, 459 F.2d 531, 173 USPQ 685 (1972).
Regarding claim 17, Jaklenec teaches in some embodiments, the one or more polymers is a EUDRAGIT®. In some embodiments, the EUDRAGIT® dissolves at a pH less than 6, preferably less than 5, 4, or 3, such as 1-3, or 1-2 (paragraph [0098]). The examiner points out that a polymer dissolving at a pH less than 6, reads on the pH-responsive polymer component being structured to be stable when exposed to an environment with a pH of 6.0 or higher. Jaklenec further teaches the polymer is also thermally stable. “Thermally stable”, as used herein, means that at a given temperature, the polymer coating does not degrade and allow leakage of the materials from the core (paragraph [0095]). Jaklenec also teaches the data in the examples show that formulations containing B9 and B12 (i.e., vitamins) exhibited no release in water at room temperature or 100° C (paragraph [0118]).
Regarding claims 88-90, Jaklenec teaches a salt formulation comprising: particles comprising one or more therapeutic agents, prophylactic agents, nutraceutical agents (i.e., payload component), a matrix formed of inert excipient having the particles dispersed therein, a pH-sensitive polymer coating on the outer surface of, or surrounding, the matrix, wherein the polymer coating is resistant to permeation of water into the matrix and provides release of the particles upon exposure to a defined pH, wherein the formulation is stable up to one hour at 100° C (claim 1); wherein the particles comprise vitamins, trace minerals, micronutrients, or combinations thereof (i.e., payload component) (claim 2). Jaklenec further teaches the term “microparticles” is also art-recognized, and includes microspheres and microcapsules, (paragraph [0041]). Jaklenec continues to teach the matrix is coated or encapsulated with one or more pH-sensitive, thermally stable biocompatible polymers (paragraph [0094]), wherein Exemplary polymers include polymethacrylates sold under the tradename EUDRAGIT® and other polysaccharides (paragraph [0097]). Jaklenec also teaches iodine (i.e., micronutrient) was encapsulated at 75.2 ± 8.9% efficiency (i.e., microparticle loading) (paragraphs [0166]). Jaklenec further teaches the particles can be dispersed into a matrix formed of one or more stabilizing materials, such as sugars and/or oils, wherein exemplary sugars include sucrose, trehalose, and carbohydrates such as plant components (i.e., excipients) (paragraph [0088]); wherein example 3 teaches 0.6 mL of nutrient/sugar solutions (1:1 ratio) were crystallized and coated with a 5% (by weight) solution of EUDRAGIT® E PO (“EPO”) in acetone (paragraph [0137]), and example 2 teaches 0.6 mL of a sugar/dye solution (0.5 M trehalose+sucrose) was crystallized in a beaker. The crystallized mixture was coated with 1 mL of a EUDRAGIT® E PO (“EPO”) solution in acetone (paragraph [0129]). But Jaklenec does not explicitly disclose wherein the particle preparation maintains water activity of less than 0.3, less than 0.2, and/or less than 0.1 in a sealed storage environment for up to 6 months at -20C, 4C, 25C, 30C and 75% relative humidity (RH), and/or at 40C and 75% RH; wherein the particle preparation is chemically stable in an unsealed storage environment for up to 6 months at 25C and 75% RH; and wherein the particle preparation is stable in direct light exposure for up to 72 hours at 37C.
However, such properties must necessarily be present. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of the claimed product. See In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, Bolton, and Shaw, 195 USPQ 430, 433 (CCPA 1977) citing In re Brown, 59 CCPA 1036, 459 F.2d 531, 173 USPQ 685 (1972).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Jaklenec does not disclose a single embodiment or example where every limitation recited in the instant claims is taught.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The claims are considered prima facie obvious to one of ordinary skill in the art at the time of filing because Jaklenec teaches all of the claimed elements. It would have been prima facie obvious to one of ordinary skill at the time of filing to have a particle preparation comprising a payload component, a polymer component, and a residual solvent content lower than a predetermined amount, a microparticle, a first excipient component, and a second excipient component, wherein: (i) the payload component comprises a nutraceutical comprising at least one antioxidant, at least one macronutrient, at least one micronutrient, at least one mineral, at least one prebiotic, at least one probiotic, at least one vitamin, or any combination thereof; (ii) the polymer component comprises a pH-responsive polymer component comprising a methacrylate, a polygalactomannan, a polysaccharide, or any combination thereof; (iii) the predetermined amount is in a range-from about 1 ppm to about 5000 ppm; (iv) microparticle loading is from 45% to 90%; (v) first excipient component loading is from 10% to 50%; (vi) second excipient component loading is from 0% to 45%, and wherein the particle preparation is formed by adding at least one of the first excipient component and the second excipient component to the microparticle loading during milling because Jaklenec teaches and contemplates all the elements.
With regards to the limitation wherein the residual solvent content is lower than a predetermined amount, wherein the predetermined amount is in a range from about 1 ppm to 5000 ppm, it would have been obvious to have a residual solvent content lower than 1 ppm to 5000pm. One would have understood in view of Jaklenec, that Formulation of MS containing HA HGPs: Poly(butyl methacrylate-co-(2-dimethylaminoethyl) methacrylate-co-methyl methacrylate) (“EPO”) was used as the polymer to formulate the MS. The formulation was conducted via a solvent evaporation technique (paragraph [0143]). It would have been obvious to one of ordinary skill in art to have a residual solvent content lower than 1 ppm to 5000 pm because Jaklenec teaches that the formulation was conducted via a solvent evaporation technique, therefore a residual solvent is present as a solvent is present and then evaporated.
With regards to the limitation wherein the first excipient component loading is from 10% to 50%, and 10% to 30%, it would have been obvious to optimize the amount of excipient in Jaklenec’s formulation. Jaklenec teaches a matrix formed of inert excipient having the particles dispersed therein, wherein the matrix formed of one or more stabilizing materials, such as sugars and/or oils, wherein exemplary sugars include sucrose, trehalose, and carbohydrates such as plant components (i.e., excipients) (paragraph [0088]), example 3 teaches 0.6 mL of nutrient/sugar solutions (1:1 ratio) were crystallized, and example 2 teaches 0.6 mL of a sugar/dye solution (0.5 M trehalose+sucrose). Therefore it would have been obvious to optimize the amount of excipient in Jaklenec’s formulation because Jaklenec teaches that sugars can be used as an inert excipient, wherein 0.6ml of nutrient/sugar solution was used as well as a solution of 0.5M of trehalose and sucrose, which one of ordinary skill can use as a starting point using routine experimentation to optimize the amount of excipient for desired results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jaklenec et al. (US20150164816A1, Published 06/18/2015) as applied to claims 1, 10, 11, 17, 21, 88-90 above, and in view Cremisi (WO2005109175A2, Published 11/17/2005).
Applicant’s Invention
Jaklenec renders obvious all the limitations of instant claim 1. Applicant’s claim 19 further adds the limitation wherein the first excipient component comprises at least on of soy lecithin, sunflower lecithin, maltodextrin 40, dryflo, and fructose, and wherein the second excipient component comprises at least one of soy lecithin and maltodextrin 40. Applicant’s claim 20 further adds the limitation wherein the particle preparation of claim 19 further comprises a third excipient loading in a range from 0% to 5%, wherein the third excipient comprises dryflo.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 19, Jaklenec teaches the particles can be dispersed into a matrix formed of one or more stabilizing materials, such as sugars and/or oils, wherein exemplary sugars include sucrose, trehalose, and carbohydrates such as plant components (i.e., excipients) (paragraph [0088]). The examiner points out that the claim 1 which claim 19 depends from recites the limitation wherein the second excipient component loading is from 0% which reads on the composition not containing a second excipient.
Regarding claim 20, The examiner points out that the claim recites the limitation wherein the third excipient component loading is from 0% which reads on the composition not containing a third excipient.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Jaklenec does not teach wherein the first excipient component comprises at least on of soy lecithin, sunflower lecithin, maltodextrin 40, dryflo, and fructose. However, this deficiency is cured by Cremisi.
In the analogous art of nutrient deficiencies, Cremisi teaches Vitamin compositions and methods for the treatment and prevention of metabolic disorders and nutrient deficiencies and their manifestations (abstract). Cremisi also teaches the compounds may also be entrapped in microcapsules prepared (page 17, third paragraph). Cremisi further teaches The formulations disclosed in this patent consist of porous particles whose pores contain an active ingredient and a polymer acting as a blocking agent that degrades and releases the active ingredient upon exposure to either low or high pH (page 15, second paragraph). Cremisi also teaches Pharmaceutical excipients and additives useful in the vitamin composition include, carbohydrates (e.g., sugars, including monosaccharides, di-, tri-, tetra-, and oligosaccharides, which can be present singly or in combination in ranges of 1-99.99% by weight or volume (page 12, second paragraph); wherein carbohydrate excipients suitable for use in the present invention include, for example, monosaccharides such as fructose and the like; disaccharides, such as sucrose, trehalose; and polysaccharides, such as maltodextrins (page 12, third paragraph).
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 at the time of filing to use maltodextrin or fructose as the first excipient component in Jaklenec’s formulation comprising a micronutrient or vitamin. Jaklenec teaches the particles can be dispersed into a matrix formed of one or more stabilizing materials, such as sugars and/or oils, wherein exemplary sugars include sucrose, trehalose, and carbohydrates such as plant components (i.e., excipients) (paragraph [0088]). One would have understood in view of Cremisi that pharmaceutical excipients and additives useful in the vitamin composition include, carbohydrates (e.g., sugars, including monosaccharides, di-, tri-, tetra-, and oligosaccharides, which can be present singly or in combination in ranges of 1-99.99% by weight or volume (page 12, second paragraph); wherein carbohydrate excipients suitable for use in the present invention include, for example, monosaccharides such as fructose and the like; disaccharides, such as sucrose, trehalose; and polysaccharides, such as maltodextrins (page 12, third paragraph). It would have been obvious to have maltodextrin 40 and fructose as the first excipient in Jaklenec’s formulation because Jaklenec teaches stabilizing materials (i.e., excipients), such as sugars and/or oils, wherein exemplary sugars include sucrose, trehalose, and carbohydrates such as plant components (i.e., excipients) (paragraph [0088]) and Cremisi teaches pharmaceutical excipients and additives useful in the vitamin composition include carbohydrate excipients, for example, monosaccharides such as fructose and the like; disaccharides, such as sucrose, trehalose; and polysaccharides, such as maltodextrins (page 12, third paragraph). Therefore, maltodextrins, fructose, sucrose, and trehalose are known for the same purpose of excipients in compositions comprising vitamins. See MPEP 2144.06.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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, Ali Soroush can be reached at (571) 272-9925. 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.
AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
Prosecution Insights