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 .
Election/Restrictions
Applicant’s election of Group I, Claims 1-11, in the reply filed on 08/27/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Accordingly, claims 12-15 are withdrawn from further consideration.
Status of Claims
Receipt of Remarks/Amendments filed on 08/27/2026 is acknowledged, the preliminary amendment of 05/07/2025 is also acknowledged. Claims 1, 3-8, and 10-15 are amended. Claims 12-15 are withdrawn in accordance with the restriction requirement discussed above. Claims 1-11 are examined on the merits herein.
Priority
The instant application filed 10/11/2024, is a 371 filing of PCT/EP2023/059635, filed 04/13/2023, which claims foreign priority to EP22168218.0, filed 04/13/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/11/2024 and 01/31/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities:
Claim 1 recites steps (i)-(iv), which represent 1-4, and then a final step of (vii), which corresponds to 7. Examiner believes this may be a typographical error and requests that the steps be defined by consecutive roman numerals;
Claim 2 recites “weighting” which appears to be a typographical error for “weighing”.
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.
1. Claims 1-11 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.
Regarding claims 1-7 and 9-10, the phrase "preferably" and/or “more preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase(s) are part of the claimed invention. See MPEP § 2173.05(d). For the sake of compact prosecution, any limitations following “preferably” or “more preferably” will be considered as optional.
Claims 8 and 11 are rejected by virtue of their dependency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 3-8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Politi, G., et al. (WO 2009135950 A2, 11/12/2009, IDS dated 10/11/2024), hereinafter Politi, in view of Park, HJ, et al.. (2016). Multiple-unit tablet of probiotic bacteria for improved storage stability, acid tolerability, and in vivo intestinal protective effect. Drug Des Devel Ther. 10:1355-64. (IDS dated 10/11/2024), and Itzaina, S.F.G., et al. (WO 2020252545 A1, 12/24/2020, IDS dated 10/11/2024), hereinafter Itzaina, as evidenced by Wikipedia (2026). Bifidobacterium animalis lactis (PTO-892), hereinafter Wikipedia, and Wikipedia (2026). Microcrystalline cellulose (PTO-892), hereinafter Wikipedia2, and SomoChem (2026). Maize Starch (PTO-892), hereinafter SomoChem.
Politi discloses a method for producing a tablet comprising (a) at least one dry granulated excipient and (b) at least one active pharmaceutical ingredient (abstract).
Regarding claim 1: The method comprises (i) preparing granules from a powder comprising one or more excipients and not comprising any active ingredient by a process characterized in that a compaction force is applied to the powder to produce a compacted mass (p. 7, para. 1; claim 1), which reads on briquetting the excipients as recited in (i). The applied compaction force may produce e.g. a compacted ribbon or slug (i.e., briquette). The ribbon or slug may then be comminuted into granules (p. 10, para. 1), for example by a flake crushing screen or other device e.g. oscillating or rotating mill (p. 10, para. 5-6; Examples), which reads on grinding the briquette as recited in (ii). The compacted mass is then provided as a mixture of fine particles and granules. The method further comprises separating and removing fine particles and/or small granules from the granules by entraining the fine particles and/or small granules in a gas stream and collecting the accepted granules (p. 7, para. 1; claim 1), which reads on fractioning the briquette (i.e., the compacted mass) as recited in (ii). The method further comprises (ii) blending the accepted granules with other components of the tablet, including the active ingredient, in granular or fine powder form (p. 7, para. 1; claim 1), which reads on adding the active ingredient to the ground briquettes and mixing as defined in (iii). Lastly, the method comprises (iii) compressing the blend to form a tablet (p. 7, para. 1; claim 1), which reads on compressing the mixture to the compressed product as recited in (iv).
Regarding claim 5: The method of Politi is for producing a tablet (abstract; claim 1).
Regarding claim 8: The excipients are selected from disintegrants and binders (claim 2). In a specific embodiment the binder is microcrystalline cellulose and the disintegrant is starch e.g. maize starch (claim 12). Microcrystalline cellulose is an example of a bulking agent, as evidenced by Wikipedia2, while maize starch is an example of an anti-caking agent, as evidenced by SomoChem. The tablet may further comprise a lubricant (claim 13). Specifically, in tableting tests, 0.25% of magnesium stearate was added to the granulate mass prior to tableting as a lubricant (p. 44, para. 3).
Politi further teaches that the tablet may comprise 0.01 - 19.99% w/w active ingredient, the balance being one or more excipients (p. 8, para. 8; claim 15). The active ingredient of the tablet may be moisture sensitive, heat sensitive or insoluble in water (p. 8, para. 9; claim 16). Tablets produced according to the method may have one or more of the following desirable properties: good homogeneity, high tensile strength, fast disintegration time, need for only a low amount of lubricant (p. 28, para. 5).
The teachings of Politi differ from that of the instantly claimed invention in that Politi does not explicitly teach wherein the active ingredient is probiotic microorganisms, nor analyzing the properties of the product, as recited in claim 1. Politi also fails to explicitly teach the further actives of claim 3, the additional method parameters of claim 4, the specific bacteria of claims 6-7, and the amounts and properties of claims 10-11.
Park teaches the preparation of a compressed product comprising probiotic microorganisms and at least one or more excipients (Preparation of probiotics-loaded tablet dosage form). Recently, there has been a surge in clinical evidence regarding the therapeutic benefits of probiotic bacteria including Lactobacillus, Bifidobacteria, and Enterococcus species to gut health and a growing commercial interest in food and/or pharmaceutical application of these bacteria. Such bacteria reads on the probiotic microorganisms of claim 1. Regular intake of probiotic strains stimulates the growth of preferred microorganisms, crowds out potentially detrimental strains, and reinforces the natural defense mechanisms. However, formulation of probiotic bacteria along with other ingredients, or even alone, in a stable dosage form is hampered by their extremely poor viability during the preparation process and/or the storage period. Majority of microorganisms generally exhibit extreme liability to oxygen, temperatures, low pH, and additives (Intro, para. 1). The bacteria of Park was compressed into tablets with highly compressible excipients and optimized for flow properties, hardness, and disintegration time (abstract).
Itzaina discloses a food supplement in the form of two tablets, a coated tablet based on chelated zinc and copper minerals, vitamins A, B3 and B6, and another simple tablet containing the probiotics Lactobacillus acidophilus and Bifidobacterium lactis (abstract; claim 1). Such bacterial species read on the probiotic microorganism of claim 1.
The tablet containing cells from a Bifidobacterium and Lactobacillus strain, may have superior stability. Superior stability is directly related to the process for obtaining the tablet. Furthermore, the composition of Bifidobacterium and Lactobacillus is especially advantageous in combination with a tablet containing a formulation of vitamin A, vitamin B6, zinc, copper and niacin ([0022]), which read on the further active ingredients of claim 3.
The process for preparing the bacterial composition comprises the following steps: a) weighing of the inputs; b) mixing and c) direct compression ([0024]; claim 2). The procedure is performed in a controlled environment with temperature and humidity strictly monitored. The temperature of the production rooms is a maximum of 25 ° C and the humidity is up to 50% RH ([0028]; [0046]-[0049]; claim 2), which overlaps with temperature and humidity of claim 4.
The bacterial strains are strains producing lactic acid and/or probiotics, and are of the species Lactobacillus acidophilus and Bifidobacterium lactis ([0027]), which read on the lactic acid bacteria of claim 6. Bifidobacterium lactis is also know as Bifidobacterium animalis subsp. lactis, as evidenced by Wikipedia, thereby further reading on the microorganism of claim 7.
The concentration of the dough agent (i.e., bulking agent) in the formulation varies from 50 to 90 percent of the total content, the antihumectant concentration ranges from 1.0 to 3.0 percent of the total content, and the lubricant concentration ranges from 0.5 to 2.0 percent of the total content ([0032]; claim 6). Together the excipients total to between 51.5 and 95 percent of the total content, which overlaps with the amount of excipients in claim 10 (i.e., 87-96%). The composition comprises: Lactobacillus acidophilus, 109 CFU whose concentration in the formulation can vary between 5 to 25 percent of the total content and Bifidobacterium lactis, 109 CFU whose concentration in the formulation can vary between 2.5 to 25 percent of the total content ([0039]). The total amount of probiotic bacteria therefore ranges from 7.5 to 50% of the total content, which overlaps with the amount of probiotic bacteria defined in claim 10 (i.e., 3-13%).
Itzaina also teaches that compression of probiotics is a process that requires special care. The greater the force applied to obtain the tablets, the greater the loss of probiotics during the manufacturing process and over the product's shelf life. Probiotics are live microorganisms that, despite being lyophilized, that is, in a latent state, are sensitive to the impact of compression ([0030]-[0031]). Additionally, physical aspects such as humidity and water activity are decisive when choosing the matrix used. The ideal range of the water in the excipients must be (0.01 - 0.2) so that there is no activation of probiotic microorganisms in the tablet and, thus, accelerate the degradation of the product, decreasing the potency and activity of the microorganisms. ([0033]).
Regarding the probiotic microorganisms of claim 1, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to use the probiotic microorganisms taught by Park and Itzaina as the active ingredient in the tableting method of Politi since such microorganisms are known and routine active ingredients in the art. One of ordinary skill in the art would have been motivated to use the microorganisms of Park or Itzaina in the compressed tablets of Politi since probiotic microorganisms are desirable active ingredients which stimulate the growth of preferred microorganisms, crowd out potentially detrimental strains, and reinforce natural defense mechanisms, as taught by Park. It is further taught that the method of Politi is especially preferred for sensitive active ingredients which are moisture or heat sensitive. Additionally, the initial compaction and granulation of the excipients alone, in the method of Politi, limits the compaction and processing steps performed on the active ingredient. Thus, one of ordinary skill in the art would have recognized the tableting method of Politi as an especially compatible method for tableting probiotic microorganism actives, which are especially sensitive to heat, moisture, and compression, as taught by Park and Itzaina.
Regarding the analysis step of claim 1, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to perform a final step of analyzing disintegration time or water activity since it is known and routine in the art to analyze a product for its desired properties and both Politi and Itzaina teach that specific disintegration times and water activity are desirable. As such, one of ordinary skill would have been motivated to analyze the disintegration time and water activity of the final tablet in order to determine if the desirable properties are actually achieved or whether they require further optimization.
Regarding the additional active ingredients of claim 3, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to further include the vitamin/mineral actives of Itzaina in the tableting process of Politi since such actives are known and routine in the art. One of ordinary skill in the art would have been motivated to include one of the additional vitamin or mineral actives of Itzaina since it is taught that the probiotics Bifidobacterium and Lactobacillus are especially advantageous in combination with vitamin A, vitamin B6, zinc, copper and niacin. Thus, one of ordinary skill in the art would have found it obvious to formulate these additional active in the same tablet as the probiotics by weighing and mixing such actives, as taught by Itzaina, with the excipient granules of Politi.
Regarding claim 4, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date, to perform the combined method in the controlled environment taught by Itzaina since a maximum of 25 ° C and the humidity up to 50% RH is known and routine in the art. One of ordinary skill in the art would have been motivated to perform the production method under such conditions since probiotic microorganisms are sensitive to moisture and heat and Itzaina teaches that these processing conditions allow for superior stability. Such conditions overlap with or encompass the conditions of claim 4. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding the probiotic microorganisms of claims 6 and 7, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to select the Lactobacillus acidophilus and Bifidobacterium lactis bacteria of Itzaina as the probiotic actives in the combined tableting method above, since such bacterial species are known and routine in the art. One of ordinary skill in the art could have selected the Lactobacillus acidophilus and Bifidobacterium lactis as the probiotic microorganisms in the combined method above, with no change in their respective function to predictably yield the instant invention. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use, such as its use as a probiotic active. See MPEP 2144.07. Both read on the microorganisms of claim 6, while Bifidobacterium lactis further reads on that of claim 7, as discussed above.
Regarding the amounts of claim 10, Politi teaches that the tablet may comprise 0.01 - 19.99% w/w of the active ingredient, the balance being one or more excipients (i.e., 80.01-99.00% w/w), while Itzaina teaches a total amount of excipients between 51.5 and 95% of the total content, and a total amount of probiotic bacteria between 7.5 to 50% of the total content. As such, both references teach ranges which overlap with the instantly claimed ranges of excipients (i.e., 87-96%) and the probiotic bacteria/active (i.e., 3-13%). It would have been prima facie obvious to one of ordinary skill in the art to use such amounts as guidance in the combined tableting process discussed above, since these are known and routine amounts of excipients and actives in the art. Furthermore, it would have been well within the abilities of an ordinary artisan to optimize the amount of excipients or probiotic bacteria in the method depending on the desired amount in the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed ranges of claim 10 through no more than routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding the properties of claim 11, because the method and, therefore, the resulting composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Additionally, Politi teaches that the tablets produced according to their method have fast disintegration time and Park teaches that tablets were optimized for flow properties, hardness, and disintegration time. Thus, one of ordinary skill in the art would recognize parameters such as disintegration time and hardness as result effective parameters which are ideally optimized. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B).
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since each of the references teach materials and methods related to compressing excipients and sensitive actives into tablets.
Claims 1-8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Politi, Park, and Itzaina as applied to claims 1, 3-8, and 10-11 above, and further in view of Pharmainform (2020). Tablet Granulation Method For Tablet Manufacturing by Sajjad Ahmad (PTO-892), hereinafter Ahmad.
The combined teachings of Politi, Park, and Itzaina are discussed above.
Itzaina further teaches that the process for preparing the bacterial composition comprises the following steps: weighing of the inputs, mixing, and direct compression ([0024]; claim 2). The weighing step reads on the weighing of (a) and (c) in claim 2. Examples 1-3 teach generating the probiotic product by mixing the excipient and active content in a manner that is sufficient to guarantee the homogeneity of the mixture ([0046]-[0049]), which reads on homogenizing a mixture of probiotic microorganisms and excipients prior to compression, as defined in (d) of claim 2. Itzaina also teaches that known processes for microorganism preparations include mixing a preparation of microorganisms and other components, drying the mixture and compacting the mixture ([008]). Such a drying step reads on drying as recited in (a) of claim 2. Physical aspects such as humidity and water activity are decisive when choosing the matrix used. The ideal range of the water in the excipients must be (0.01 - 0.2) so that there is no activation of probiotic microorganisms in the tablet and, thus, accelerate the degradation of the product, decreasing the potency and activity of the microorganisms. ([0033]).
The combined teachings of Politi, Park, and Itzaina differ from that of the instantly claimed invention in that they do not explicitly teach every step of claim 2.
Ahmad teaches granulation as a process of converting powders into granules to form tablets (p. 1, para. 1). Dry granulation method is used for pharmaceutical products which are moisture sensitive and heat sensitive (p. 3, final paragraph). The steps of dry granulation are: 1. Weighing, 2. Sieving, 3. Pre Mixing, 4. Slugging/Roller Compaction, 5. Sieving/Screening of Slugs, 6. Final Mixing/Blending (p. 4). Such steps read on weighting and sieving as recited in (a) and (c) and mixing and homogenizing as recited in (b) and (d) of claim 2.
First, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to dry the excipients prior to their use since drying materials prior to compression is known and routine in the art as taught by Itzaina. One of ordinary skill in the art would have been specifically motivated to perform an initial drying step of the excipients since low water content is ideal in excipients used with probiotic microorganisms, as taught by Itzaina. As such, the drying component of step (a) in claim 2 is obvious.
It would have been further prima facie obvious to weigh, sieve, and pre-mix the excipients prior to compaction since weighing, sieving, and pre-mixing are known and routine steps performed prior to slugging/roller compaction as taught by Ahmad. Itzaina also teaches that weighing and mixing are known and routine in the art. Given the broader method of Politi above, which teaches dry granulation of excipients alone and then addition of the active ingredients, one of ordinary skill in the art would have found it obvious to perform the weighting, sieving, and pre-mixing step of the excipients prior to forming the granules and adding in the actives. One of ordinary skill in the art could have therefore applied the known techniques of weighing, sieving, and pre-mixing to the excipients in the combined method to predictably yield the instant invention. As such, the weighing, sieving, and mixing/homogenizing excipients as recited in (a) and (b) of claim 2 is obvious.
It would have been further prima facie obvious to weigh and sieve the probiotic microorganisms prior to adding them to the excipient mixture since weighing and sieving are known and routine steps performed in the art as taught by Ahmad. Itzaina also teaches that weighing the microorganisms is known and routine in the art. Given the broader method of Politi above, which teaches adding the active ingredients to the pre-granulated excipients, one of ordinary skill in the art would have found it obvious to perform a weighing and sieving step of the actives prior to their addition into the excipient granules. It would have then been prima facie obvious to mix the weighed and sieved microorganisms with the excipient granules to homogenize them together prior to final compression, as taught by Itzaina. One of ordinary skill in the art could have therefore applied the known techniques of weighing, sieving, and mixing to the microorganisms in the combined method to predictably yield the instant invention. As such, the weighing, sieving, and mixing/homogenizing steps recited in (c) and (d) of claim 2 are obvious.
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since each of the references relate to typical processes utilized in granulating and tableting.
Claims 1 and 3-11 are rejected under 35 U.S.C. 103 as being unpatentable over Politi, Park, and Itzaina as applied to claims 1, 3-8, and 10-11 above, and further in view of Valentine, W., et al. (US 4684534 A, 08/04/1987, PTO-892), hereinafter Valentine.
The combined teachings of Politi, Park, and Itzaina are discussed above.
As discussed above, the tablets of Politi comprise excipients in the form of disintegrants and binders (claim 2). The tablet may further comprise a lubricant (claim 13). Specifically, in tableting tests, 0.25% of magnesium stearate was added to the granulate mass prior to tableting as a lubricant (p. 44, para. 3), which reads on the lubricant of claim 9. Politi further teaches wherein the binder may also be selected from fructose, water-soluble polysaccharides, and two or more in combination (p. 7, para. 5; claim 5). Excipients or other ingredients usable in the pharmaceutical industry also include fructose, silicon dioxide, maltodextrin and magnesium stearate (p. 26-28, bridging paragraph).
Itzaina further teaches that the excipient matrix of the probiotic formulation is composed of a grease agent, an anti-humectant, and a lubricant ([0032]). The antihumectant is preferably silicon dioxide and the lubricant is preferably magnesium stearate ([0032]), both of which read on the anti-caking agent and lubricant of claim 9.
The combined teachings of Politi, Park, and Itzaina differ from that of the instantly claimed invention in that they do not explicitly teach the combined use of fructose and maltodextrin, with magnesium stearate, and silicone dioxide, as recited in claim 9.
Valentine discloses tablets having a softer interior which quickly liquifies when the tablet and shell are broken into pieces and contacted by the liquid. The tablet has particular utility as a chewable tablet which resists absorption of moisture but which quickly liquifies and melts in the mouth within seconds after mastication, even if the tablet contains considerable amounts of active ingredients that do not dissolve well or at all in the mouth. Also disclosed are agglomerates from which the tablets are directly compressed, and processes for making the agglomerates and tablets. The excipient or base material of the tablet is made from carbohydrates including dextrose, dextrose monohydrate, maltodextrin, fructose, sucrose, lactose, maltose and xylose held together by small quantities of a carbohydrate binder such as maltodextrin (abstract). Specific examples include fructose and maltodextrin agglomerates (Table A, entry III and IV), which reads on the bulking agent of claim 9. It is further taught that the agglomerate can be formed from the carbohydrate particles and the water-soluble binder without an active ingredient, and the active ingredient and agglomerate can be mixed to cause the active ingredient to be entrained by and dispersed in the agglomerate (col. 3, lines 30-34).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to select fructose and maltodextrin as the binder/bulking agent in the combined tableting method of Politi, Park, and Itzaina since fructose and maltodextrin are known and routine bulking agents in the art as taught by Valentine. One of ordinary skill in the art would have been motivated to use these excipients since together they are taught by Valentine to resists absorption of moisture, which would be beneficial in the combined tableting process above which is used for moisture sensitive probiotic actives. One of ordinary skill in the art could have added the fructose and maltodextrin of Valentine as excipients in the tableting process discussed above using known techniques to predictably yield the instant invention.
It would have been further prima facie obvious to also use magnesium stearate and silicone dioxide as excipients in the above tableting method since these are known and routine excipients in the art as taught by Politi and Itzaina. One of ordinary skill in the art would have been motivated to use these excipients since they are especially desired in tablets containing sensitive probiotic actives. One of ordinary skill in the art could have included these excipients in the tableting process discussed above using known techniques to predictably yield the instant invention.
One of ordinary skill in the art would have had a reasonable expectation of success in combining these excipients since Politi welcomes fructose, silicon dioxide, maltodextrin and magnesium stearate as excipients in the tableting procedure.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 9-5 (Flex).
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616
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