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 .
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, 3-8, 10, 17-25, 28-44, and 47 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.
Amended claim 1 recites the phrase “at least probiotic microorganism as active ingredient.” It is unclear what the phrase “at least” is attempting to limit in context to the active ingredient. It is unclear if ‘at least’ is attempting to state that there is another active ingredient in addition to the “at least probiotic microorganism.”
Claim 5 recites: The product of claim 1, wherein the product further comprises:(i) a lubricant and/or an anti-caking agent, an aromatizing agent, and optionally a natural sweetener; or (ii) a lubricant and/or an anti-caking agent, a binder, an aromatizing agent, and optionally a natural sweetener. The scope of the alternatives required are not clearly defined and unclear. It is unclear if the claim only requires a lubricant due to the recitation “and/or” following lubricant or the intent is to claim a combination of additives . For purposes of applying art, the claim will be interpreted as only requiring the lubricant. It is suggested that Markush language is utilized to clearly define the alternatives.
Claim 6 recites “rice extract blend.” It is unclear what a rice extract blend is and the specification only provides an example of a trademarked good. It is unclear is the scope is to a component extracted from rice, rice itself, rice blended with other components, therefore, one would not if one is infringing the scope. Further, claim 6 recites: The product of claim 1, wherein the product further comprises a rice extract blend as a lubricant and/or anti-caking agent, pregelatinized corn starch as a binder, a flavor as an aromatizing agent, and a natural sweetener. The scope of the alternatives required are unclear. It is unclear if the claim only requires a rice extract blend as lubricant due to the recitation “and/or” following lubricant or the intent is to claim a lubricant, a binder, a flavor and sweetener due to the recitation “and” preceding sweetener. For purposes of applying art, the claim will be interpreted as only requiring the lubricant. It is suggested that Markush language is utilized to clearly define the alternatives.
Claim 23 recites, The product of claim 4, wherein the one or more further excipients comprise a lubricant and/or an anti-caking agent, a binder, and/or an aromatizing agent. The scope of the alternatives required is unclear. It is unclear if the claim only requires a lubricant as denoted by the ‘and/or” or if the claim requires a lubricant. For purposes of applying art, the claim will be interpreted as only requiring the lubricant. It is suggested that Markush language is utilized to clearly define the alternatives.
As discussed above regarding claims 5-6 and 23, it appears only one alternative is required. The scope of claim 24 is unclear if all the additives are required since claim 23 does not define the alternatives required and claim 24 does not clarify what alternatives are required since it uses the phrase “and/or” and does not recite “further comprising an anticaking agent…, a binder….and aromatizing agent ” and rather just defines what each additive is, using the phrase ‘wherein”. Similarly the scope of claims 25 and 28-30 is unclear since the flavor is an optional alternative. Since the base claim only requires a lubricant as the additive due to the phrase ‘and/or’, a flavor or other additives are not required. If the other additives are required in claims 24-25, 28-30, the claim should be amended to reflect this. For instance, if the flavor is required, then the claim needs to recite, “the product further comprising a flavor….” Similarly claim 24 should be amended to clearly state further comprising….For instance, the product of claim 24 further comprising a lubricant selected from the group consisting of; a anticaking agent selected from the group consisting of; a binder from the group consisting of…..etc. Use of Markush language and ‘further comprising” is suggested to define the scope.
Claims 17, and those depending on 17, are rejected because it recited method steps using the product of claim 1 at recited step (iv) (see, e.g., MPEP § 2173.05(p)(II)). While steps (i)-(iii) of claim 17 are directed to product-by-process limitations, which are acceptable per MPEP § 2173.05(p)(I), the steps of claim 17 are understood to actually perform active method steps on the completed product as claimed at instant claim 1, which renders the claim scope indefinite because it is unclear when direct infringement would occur (i.e., before, during, or after the active methods steps are completed). For instance, claim 17 is a product-by-process limitation that adds excipients to the product and adds analysis steps of the product. Accordingly, the claims are rejected as indefinite. For purposes of applying prior art, accordingly the claims will be interpreted per MPEP § 2173.05(p)(I).
The dependent claims directly or indirectly from an indefinite base claim and fail to reconcile the indefiniteness of the base claim; accordingly, these claims are also rejected for the reasons applied above.
Claim Interpretation
Claim 5 recites: The product of claim 1, wherein the product further comprises:(i) a lubricant and/or an anti-caking agent, an aromatizing agent, and optionally a natural sweetener; or (ii) a lubricant and/or an anti-caking agent, a binder, an aromatizing agent, and optionally a natural sweetener. This claim is interpreted to require only a lubricant due to the recitation “and/or” following lubricant.
Claim 6 recites: The product of claim 1, wherein the product further comprises a rice extract blend as a lubricant and/or anti-caking agent, pregelatinized corn starch as a binder, a flavor as an aromatizing agent, and a natural sweetener. This claim is interpreted to require only rice extract blend as lubricant due to the recitation “and/or” following lubricant.
Claim 23 recites: The product of claim 4, wherein the one or more further excipients comprise a lubricant and/or an anti-caking agent, a binder, and/or an aromatizing agent. This claim is interpreted to require only rice extract blend as lubricant due to the recitation “and/or” following lubricant.
It is suggested that Markush language is utilized to clearly define the alternatives.
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.
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 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.
Claims 1, 3-5, 7-8, 10, 17-20, 23-29, 31-44, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Lindley (EP Publication No. 0028905 B1) in view of von Maltzahn (US 2017/0151269 A1, previously presented), as evidenced by Culturelle (“Culturelle Digestive Daily Probiotic Capsules”) in view of WO 2020252545.
Lindley’s general disclosure relates to compressed tablets containing isomaltulose and the use thereof (see Lindley at Title; at pg. 2).
Regarding claim 1, Lindley teaches a compressed tablet/lozenge or product comprising isomaltulose and teaches the use of isomaltulose as a desirable and suitable diluent in such products (see Lindley at pg. 3, lines 1-13). Particularly, Lindley teaches that isomaltulose is “especially suitable for use as a diluent material in tablets… [has] better solubility in water than lactose, does not demand careful, controlled granulation, and can be formed into tablets by direct compression with a lubricant…has a pleasant, not very sweet, reasonably bland taste and can allow other ingredients to exert a flavoring agent…can contribute bulk, body, mouthfeel and other desired characteristics to tablets for human and animal consumption” (see Lindley at pg. 3, lines 5-13). Lindley specifically teaches “Exceptionally, isomaltulose can give coherent tablets by direct compression with a lubricant, thereby avoiding the need for a binder. Isomaltulose can be used as diluent for various physiologically active ingredients. [0019]
Regarding claims 7 and 31-32, Lindley teaches that the tablet or lozenge can comprise up to 97% isomaltulose, ranging typically from 10-95%, and can comprise from 3-90% of the active ingredient (see Lindley at page 4 at lines 4-10). Further, Lindley teaches that the tables typically weigh from 5 mg to 5 g (see Lindley at page 4, lines 12-13). It is noted that where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (See MPEP 2144.05 I). It is noted that “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” (See MPEP 2144.05 II).
Additionally, regarding claim 8 and 36-38, Lindley teaches the dissolution of the compressed tablets and notes that isomaltulose-based tablets were faster to dissolve than lactose-based tablets, particularly at lower temperatures (see Lindley at pg. 4, lines 60-65). To reiterate, it is within the skill of an artisan to manipulate the amount of disintegrants to yield the desired disintegration time.
The primary reference differs from the instant claims as follows: Although Lindley teaches isomaltulose-based tablets, Lindley does not teach tablets containing probiotics as required by instant claim 1. Further Lindley does not teach the amended limitation of compression force of 6 to10kN as required by instant claim 1.
von Maltzahn’s general disclosure relates to the preparation of glycan therapeutics, pharmaceutical compositions, and medical foods, comprising micronutrients, polyphenols, prebiotics, probiotics and other agents (see Abstract).
Regarding claim 1, von Maltzahn teaches a composition comprising a probiotic (see von Maltzahn at ¶[0268]; at ¶[0286]-[0288]). Additionally, von Maltzahn teaches the composition can be compressed (see von Maltzahn at ¶[0302]) and in the form of a lozenge (see von Maltzahn at ¶[0315]).
Regarding claim 3, von Maltzahn teaches the composition can comprise lactic acid bacteria (see von Maltzahn at ¶[0286]-[0288]).
Regarding claim 4, von Maltzahn teaches the composition can comprise one or more excipients or carriers (see von Maltzahn at ¶[0268]).
Regarding claim 5, von Maltzahn teaches the composition can further comprise lubricants (see von Maltzahn at ¶[0268]), active ingredient (see von Maltzahn at ¶[0302]), and sweeteners (see von Maltzahn at ¶[0317]).
Regarding claim 8 and 36-38, von Maltzahn teaches the product contains disintegrants to facilitate tablet disintegration after administration and provides examples thereof (see von Maltzahn at ¶[0372]). It is within the skill of artisan to manipulate the amount of disintegrants to yield the desired disintegration time. A skilled artisan could readily modify a known compound, a disintegrant, in a tablet or lozenge in a known and predictable manner to routine optimize the disintegration time, wherein disintegration time can be predictably increased or decreased by altering the amount of disintegrant present in the tablet or lozenge (see MPEP 2144.05 (II)). Further, the composition as claimed is similar to the prior art’s composition, probiotic and isomaltulose, thus the properties would be the same absent evidence otherwise.
Regarding claim 10, von Maltzahn teaches that the product may be contained in a package (see von Maltzahn at ¶[0372]).
Regarding claims 17-18, 39, 42, and 44, instant claims product-by-process limitations. Per MPEP 2113(I), patentability is based on the product itself (structure) rather than the method of production. Here, the process limitations presently recited are not related to a structure and therefore are presumably met by the prior art, absent evidence to the contrary. Applicant has not provided any evidence that the process including the compression force provides a different structure and therefore, it is the position of the examiner the combination of references would produce the same product.
Regarding claim 19, von Maltzahn teaches suitable probiotic microorganisms includes those from the genus of Bifidobacterium, Lactobacillus, Enterococcus, and Streptococcus (see von Maltzahn at ¶[0286]).
Regarding claim 20, von Maltzahn teaches L. crispatus, L. casei, L. rhamnosus,
L. fermentum, L. plantarum, L. reuteri, S. salivarius and B. animalis (see von Maltzahn at ¶[0286] & [0288]).
Regarding claim 23 and 40, von Maltzahn teaches one or more excipients or carriers including diluents, binders, disintegrants, dispersants, lubricants, glidants, stabilizers, surfactants, flavoring agents, and colorants (see von Maltzahn at ¶[0268]).
Regarding claim 24, 28, 41, and 43, von Maltzahn teaches that lubricant comprises magnesium stearate, a glidant or anti-caking agent comprises silicon dioxide, and binders comprise hydroxylpropylcellulose and natural substitutes such as corn starch and pregelatinized starch, and teaches a flavoring agent, natural sweeteners, and one or more active ingredients (see von Maltzahn at ¶[0317]; at ¶[0302]).
Regarding claim 25 and 29, von Maltzahn teaches the flavoring agent may be mint, cherry, anise, peach, apricot, licorice, raspberry, vanilla, and the like (see von Maltzahn at ¶[0317]) and teaches a polyphenol extracted from the juice of a strawberry (see von Maltzahn at ¶[0352]). Additionally, von Maltzahn teaches the sweetener can comprise stevia (see von Maltzahn at ¶[0317]). It is within the skill level of one of ordinary skill in the art to choose a flavor, such as strawberry, given the teachings above.
von Maltzahn teaches that the composition can comprise vitamins and minerals as dietary ingredients or active ingredients (see von Maltzahn at ¶[0299]).
von Maltzahn teaches the composition can comprise vitamin D (see von Maltzahn at ¶[0274]). It is within the skill level of an ordinary artisan with the teachings of von Maltzahn to use vitamin D3 in the composition.
Regarding claims 33-35, von Maltzahn teaches that the composition contains probiotic bacterial strains in an amount compressed from 1x107-1x1013 CFU/dose (see von Maltzahn at ¶[0540]). As evidence by Culturelle, a dose of 10 billion CFUs or 1x1010 CFUs of Lactobacillus rhamnosus GG is equal to about 40 mg. von Maltzahn discloses a dosage amount from 5 mg/kg to 500 mg/kg, which would convert to a concentration from 8-100% (see von Maltzahn at ¶[0537]). It is within the skill of an ordinary artisan to use the teachings of von Maltzahn to arrive at a concentration or amount in mg as claimed. It is reiterated that where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (See MPEP 2144.05 I). It is reiterated that “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” (See MPEP 2144.05 II).
In the interest of compact prosecution and although applicant has not provided any evidence that the compression force produces a different product, WO ‘545 is cited for its teaching of the state of the art and the use of the instantly claimed compression force.
WO ‘545 teaches a tablet containing the probiotics Lactobacillus acidophilus and Bifidobacterium lactis and the method of preparing using direct compression. [0024]. All of these steps are carried out in a controlled environment, that is, 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% U.R [0028]
WO teaches “A first goal to achieve is to have an adequate number of UFCs (colony-forming unit) per day…. The bacterial strains of the present invention are strains producing lactic acid and / or probiotics, and are of the species Lactobacillus acidophilus and Bifidobacterium lactis and are in the 10 .sup.9 UFC range.” [0027].
WO teaches, “Compression of probiotics is a process that requires special care. The force required to generate tablets must be finely controlled so that it does not cause significant impacts on the viability of the strains present in the formulation. 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.” WO teaches the use of 8kn and 10 compression force. WO ‘545 teaches the excipient and tis ability to take the impact of the punches is important [0031] “Physical aspects such as humidity and water activity are decisive when choosing the matrix used….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. The excipients compatible with the probiotics must have other characteristics besides low water activity and controlled humidity, they must also be compressible with a low compression force, since the impact of the compression directly interferes in the viability of the probiotic strains.” [0033]. [0034] teaches the preservation of the probiotics for 24 months (reads on instant claim 47).
Therefore, first, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reasons:
The ordinary artisan would be motivated to use isomaltose as an excipient in a compressed lozenge probiotic composition. An ordinary artisan would expect the combination of isomaltulose as an excipient or a desirable and suitable diluent and probiotic microorganisms as an active ingredient to provide predictable results and would readily improve a known probiotic compressed lozenge. A conclusion of obviousness can be made when: combining prior art elements according to known methods yields predictable results, use of known technique improves similar devices (methods, or products) in the same way, and some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings arrives at the claimed invention (see MPEP 2143 (I)(A),(C),(G)). Further, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (see MPEP 2144.07).
In this case, an ordinary artisan would recognize from the teachings of Lindley and von Maltzahn that isomaltulose as an excipient or diluent in composition can be predictably and desirably combined with a probiotic microorganisms to predictably form a compressed product or lozenge having the benefits described by both references; therefore, its intended use is well-known and recognized in the prior art. Further, an ordinary artisan could readily combine known probiotic microorganisms with isomaltulose for its known purpose to yield predictable results or improve a product (i.e., a probiotic lozenge product). An ordinary artisan would therefore arrive at the claimed invention by simple combination of prior art elements to arrive at a known probiotic lozenge product comprising a known excipient, isomaltulose. Moreover, regarding the product-by-process limitations, per MPEP 2113, burden shifts to applicant to show the unobvious difference with evidence once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art.
However, in the interest of compact prosecution and if applicant provides evidence, the following obviousness rationale is made: It would have been obvious for one of ordinary skill in the art to combine the references and utilize the instant compression force. Once would have been motivated to do so with reasonable expectation since WO ‘545 teaches the use of minimal force such as 8k/N and 10k/N to preserve the viability of the probiotics during storage. Moreover, WO ‘545 teaches the excipient chosen to be compatible with the probiotics must have (1) low humidity and water activity 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 and (2) must also be compressible with a low compression force, since the impact of the compression directly interferes in the viability of the probiotic strains.” As taught by Lindley, isomaltulose has the characteristics required.
Claim 6 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Lindley (EP Publication No. 0028905 B1) in view of von Maltzahn (US 2017/0151269 A1, previously presented) as evidenced by Culturelle (“Culturelle Digestive Daily Probiotic Capsules”) in view of WO 2020252545 and further in view of Schultz (“Rice-based excipients can boost organic, non-GMO claims for supplements”, previously presented).
The teachings of von Maltzahn, Lindley, and WO ‘545 have been set forth above.
However, the references do not teach the use of rice extract blend as an excipient.
Schultz’s general disclosure relates to the benefits of using rice-based excipients.
Schultz teaches that rice bran-based excipients can be used to substitute for non-organic lubrication, anti-caking, and flow agents in supplement formulations, including “a tablet or capsule”, which an artisan would readily appreciate include lozenges (see Schultz at p. 1 at para. 1-5).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reasons:
The ordinary artisan would be motivated to select rice bran-based excipients for lubrication or anti-caking (see Id.). An ordinary artisan would expect the selection or substitution for non-organic lubricant or anti-caking agents to provide predictable results and would readily improve the known probiotic product. A conclusion of obviousness can be made when: simple substitution of one known element for another obtains predictable results, use of known technique to improve similar products in the same way, and substituting equivalents known for the same purpose (see MPEP 2143 (I)(B),(C); MPEP 2144.06 (II)).
In this case, an ordinary artisan would recognize that the known rice bran-based excipients can be substituted for another lubricant or anti-caking agent (i.e., the same purpose – lubrication and anti-caking) and the use thereof is known to provide an organic alternative (i.e., an improvement to the product). The simple substitution for rice bran-based excipients would obtain predictable results and/or improve the product, since rice bran-based excipients have a well-known purpose recognized by the art.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Lindley (EP Publication No. 0028905 B1) in view of von Maltzahn (US 2017/0151269 A1, previously presented) as evidenced by Culturelle (“Culturelle Digestive Daily Probiotic Capsules in view of WO 2020252545 and further in view of Klassen (EP Publication No. 2452575 A1).
The teachings of von Maltzahn, Lindley, and WO ‘545 have been set forth above.
The references do not teach specific bacterial strains.
Klassen’s general disclosure relates to a nutritional composition having varying probiotic content (see Abstract). Klassen teaches the use of Streptococcus salivarius K12 as a probiotic microorganism in the nutritional composition (see Klassen at ¶[0028]). Klassen teaches the use of Lactobacillus rhamnosus LGG as a probiotic microorganism in the nutritional composition (see Klassen at ¶[0029]).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reasons:
The ordinary artisan would be motivated to select Streptococcus salivarius K12 and Lactobacillus rhamnosus LGG as a probiotic microorganism in the nutritional composition (see Klassen at ¶[0029]). An ordinary artisan would expect the selection to provide predictable results and would readily improve the known probiotic lozenge product. A conclusion of obviousness can be made when: combining prior art element according to known methods yield predictable results, the use of known technique improves similar devices (methods, or products) in the same way, and some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings arrives at the claimed invention (see MPEP 2143 (I)(A),(C),(G)). In this case, the known probiotic lactic acid bacteria, Streptococcus salivarius K12 and Lactobacillus rhamnosus LGG, can be used in the known the probiotic lozenge product comprising isomaltulose to yield predictable results and/or improve the product by providing beneficial health effects (see Klassen at ¶[0049]). An ordinary artisan could with the teachings provided by the prior art modify or combine prior art elements to arrive at the claimed invention.
Claims 1, 3-5, 7-8, 10, 17-19, 23-25, 28-29, 31-42, 44, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020252545 in view of Lindley (EP Publication No. 0028905 B1).
WO ‘545 teaches a tablet containing the probiotics Lactobacillus acidophilus and Bifidobacterium lactis and the method of preparing using direct compression. [0024]. The composition comprises the probiotics and an excipients. A lozenge is defined as a medicinal tablet with the intended use of dissolving in the mouth and therefore WO teaches a lozenge since WO teaches a small tablet that can dissolve in the mouth.
WO teaches “A first goal to achieve is to have an adequate number of UFCs (colony-forming unit) per day…. The bacterial strains of the present invention are strains producing lactic acid and / or probiotics, and are of the species Lactobacillus acidophilus and Bifidobacterium lactis and are in the 10 .sup.9 UFC range.” [0027] WO teaches the concentration of the probiotic in the formulation can be 5-25% of Lactobacillus acidophilus and 2.5-25% Bifidobacterium lactis [0039]. Excipients include lubricants (magnesium stearate), anti-humectants (silicon dioxide). Lactose, corn starch (reads on natural substitute binder), microcrystalline cellulose. [0032]
WO teaches, “Compression of probiotics is a process that requires special care. The force required to generate tablets must be finely controlled so that it does not cause significant impacts on the viability of the strains present in the formulation. 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.” WO teaches the use of 8k/N and 10k/N compression force. WO ‘545 teaches the excipient and its ability to take the impact of the punches is important [0031] “Physical aspects such as humidity and water activity are decisive when choosing the matrix used….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. The excipients compatible with the probiotics must have other characteristics besides low water activity and controlled humidity, they must also be compressible with a low compression force, since the impact of the compression directly interferes in the viability of the probiotic strains.” [0033]. [0034] teaches the preservation of the probiotics for 24 months. All of these steps are carried out in a controlled environment, that is, 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% U.R [0028]
WO teaches does not teach the instantly claimed excipient, isomaltulose.
Lindley teaches a compressed tablet/lozenge or product comprising isomaltulose and teaches the use of isomaltulose as a desirable and suitable diluent in such products (see Lindley at pg. 3, lines 1-13). Particularly, Lindley teaches that isomaltulose is “especially suitable for use as a diluent material in tablets… [has] better solubility in water than lactose, does not demand careful, controlled granulation, and can be formed into tablets by direct compression with a lubricant…has a pleasant, not very sweet, reasonably bland taste and can allow other ingredients to exert a flavoring agent…can contribute bulk, body, mouthfeel and other desired characteristics to tablets for human and animal consumption” (see Lindley at pg. 3, lines 5-13). Lindley specifically teaches “Exceptionally, isomaltulose can give coherent tablets by direct compression with a lubricant, thereby avoiding the need for a binder. Isomaltulose can be used as diluent for various physiologically active ingredients. [0019]
Lindley teaches that the tablet or lozenge can comprise up to 97% isomaltulose, ranging typically from 10-95%, and can comprise from 3-90% of the active ingredient (see Lindley at page 4 at lines 4-10). Further, Lindley teaches that the tablets typically weigh from 5 mg to 5 g (see Lindley at page 4, lines 12-13). It is noted that where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (See MPEP 2144.05 I). It is noted that “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” (See MPEP 2144.05 II).
Lindley teaches a composition that comprise a binder, peppermint (reads on aromatizing agent), magnesium stearate (reads on lubricant), starch (reads on natural substitute of HPMC), and sucrose (sweetner).
Therefore, first, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reasons:
The ordinary artisan would be motivated to use isomaltose as an excipient in a compressed lozenge probiotic composition. An ordinary artisan would expect the combination of isomaltulose as an excipient or a desirable and suitable diluent and probiotic microorganisms as an active ingredient to provide predictable results and would readily improve a known probiotic compressed lozenge. Further, the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (see MPEP 2144.07).
In this case, an ordinary artisan would recognize from the teachings of WO ‘545 and Lindley that isomaltulose as an excipient or diluent in composition can be predictably and desirably combined with a probiotic microorganisms to predictably form a compressed product or lozenge having the benefits described by both references; therefore, its intended use is well-known and recognized in the prior art. WO ‘545 teaches the excipient chosen to be compatible with the probiotics must have (1) low humidity and water activity 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” and isomaltulose has the characteristics required since Lindley teaches isomaltulose has better solubility in water than lactose and can be directly compressed, i.e. without adding any component that would accelerate the degradation of the product.
Regarding claim 8 and 36-38, Lindley teaches the dissolution of the compressed tablets and notes that isomaltulose-based tablets were faster to dissolve than lactose-based tablets, particularly at lower temperatures (see Lindley at pg. 4, lines 60-65). To reiterate, it is within the skill of an artisan to manipulate the amount of disintegrants to yield the desired disintegration time. Furthermore since the structure claimed is similar to the combination of WO and Lindley, probiotics and isomaltutlose, the properties should be similar absent evidence otherwise.
Regarding claims 5, 23-25, 28-29, note the 112b rejections and claim interpretation discussed above. WO teaches magnesium stearate (lubricant).
Regarding claim 10, it is within the skill of an artisan to package the tablets/lozenge for commercial sale.
Regarding 33-35, since WO ‘545 teaches be 5-25% of Lactobacillus acidophilus and 2.5-25% Bifidobacterium lactis and Lindley teaches that the tablets typically weigh from 5 mg to 5 g (see Lindley at page 4, lines 12-13) and the claimed concentrations of isomaltulose, it is noted “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” (See MPEP 2144.05 II). It is within the skill of an artisan to manipulate the amount of the active based on the intended treatment of the tablet.
Regarding the product-by process claims, note the 112b rejection. Per MPEP 2113 the claims are directed to product-by-process limitations and it is applicant’s burden to provide evidence of a structural distinction imparted by the process limitations since WO ‘545 and Lindley render the claimed product obvious.
Claim 6 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020252545 in view of Lindley (EP Publication No. 0028905 B1) in further in view of Schultz (“Rice-based excipients can boost organic, non-GMO claims for supplements”, previously presented).
The teachings of WO ‘545 and Lindley have been set forth above.
However, the references do not teach the use of rice extract blend as an excipient.
Schultz’s general disclosure relates to the benefits of using rice-based excipients.
Schultz teaches that rice bran-based excipients can be used to substitute for non-organic lubrication, anti-caking, and flow agents in supplement formulations, including “a tablet or capsule”, which an artisan would readily appreciate include lozenges (see Schultz at p. 1 at para. 1-5).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reasons:
The ordinary artisan would be motivated to select rice bran-based excipients for lubrication or anti-caking (see Id.). An ordinary artisan would expect the selection or substitution for non-organic lubricant or anti-caking agents to provide predictable results and would readily improve the known probiotic product. A conclusion of obviousness can be made when: simple substitution of one known element for another obtains predictable results, use of known technique to improve similar products in the same way, and substituting equivalents known for the same purpose (see MPEP 2143 (I)(B),(C); MPEP 2144.06 (II)).
In this case, an ordinary artisan would recognize that the known rice bran-based excipients can be substituted for another lubricant or anti-caking agent (i.e., the same purpose – lubrication and anti-caking) and the use thereof is known to provide an organic alternative (i.e., an improvement to the product). The simple substitution for rice bran-based excipients would obtain predictable results and/or improve the product, since rice bran-based excipients have a well-known purpose recognized by the art.
Furthermore, it is well-within the ordinary skill in the art to arrive at selecting a known lubricant or anti-caking agent (i.e., rice bran-based excipients) and substitute it for another lubricant or anti-caking agent in a similar known probiotic product.
Regarding claim 30, note the 112b rejections and claim interpretation discussed above.
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020252545 in view of Lindley (EP Publication No. 0028905 B1) further in view of Klassen (EP Publication No. 2452575 A1).
The teachings of WO ‘545 and Lindley have been set forth above. WO’545 teaches a nutraceutical probiotic tablet comprising Bifidobacterium and Lactobacillus for dysbiosis (imbalance of the bacteria in the gut) and food supplement. See abstract.
The references do not teach specific bacterial strains.
Klassen’s general disclosure relates to a nutritional composition having varying probiotic content (see Abstract). Klassen teaches the use of Streptococcus salivarius K12 as a probiotic microorganism in the nutritional composition (see Klassen at ¶[0028]). Klassen teaches the use of Lactobacillus rhamnosus LGG as a probiotic microorganism in the nutritional composition (see Klassen at ¶[0029]). The composition is used to treat gut discomfort.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reasons:
The ordinary artisan would be motivated to select Lactobacillus rhamnosus LGG as a probiotic microorganism in the nutritional composition (see Klassen at ¶[0029]). An ordinary artisan would expect the selection to provide predictable results and would readily improve the known probiotic lozenge product. A conclusion of obviousness can be made when: combining prior art element according to known methods yield predictable results, the use of known technique improves similar devices (methods, or products) in the same way, and some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings arrives at the claimed invention (see MPEP 2143 (I)(A),(C),(G)). In this case, the known probiotic lactic acid bacteria, Lactobacillus rhamnosus LGG, can be used in a nutraceutical to treat gut issues. Moreover, it is within the skill of an artisan to add other probiotics such as Streptococcus salivarius K12 for an additive effect of treating bacterial gut imbalance.
Response to Arguments
Applicant’s arguments have been considered but are moot because of the new grounds of rejection necessitated by the amendment filed 6/10/2025. However, pertinent arguments will be addressed below regarding Lindley and von Maltzahn.
Applicant argues the prior art does not teach the amended limitation. Per MPEP 2113, the applicant has the burden to provide evidence that the instant claims are structurally different than the prior art. Applicant argues that the instantly claimed compression force provides a therapeutically effective amount of probiotic active microorganisms and have the desired properties of water activity, disintegration time, mass, etc. as seen in the examples and tables. First, it is noted that the independent claim does not claim any concentration of the probiotic, any disintegration time, mass, or any specific parameters. Applicant has merely amended the claims to recite a compression force. The claims do not even recite viable microorganisms. Second, applicant merely responds by stating one should look to the examples and tables. However, it is applicant’s burden with product-by-process claims to specify the differences between the claimed invention and the prior art. It is unclear what specific examples applicant is pointing to. It is noted that the examples contain other excipients that can effect the properties applicant is arguing. Thus, assuming arguendo applicant’s arguments had some merit, the claims are not commensurate in scope. See MPEP 716.03. Also, in the interest of compact prosecution, WO ‘545 teaches the state of the art which demonstrates that the use of the instantly claimed compression force was known and provided the desired property applicant argues, i.e. WO ‘545 teaches the use of minimal force such as 8k/N and 10k/N to preserve the viability of the probiotics during storage.
Conclusion
No claims are allowed.
Correspondence Information
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/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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