DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/24/25 has been entered.
Response to Amendment
This action is written in response to applicant’s amendments received on 10/24/35.
The rejection of claims 71-73 under 35 USC 103 is overcome by amendment.
Claims 11-12, 17, and 32 are withdrawn due to restriction requirement.
Examiner amendments to place the application in condition for allowance were proposed but no response was received.
Amended claims 9-10, 14-15, 19, 24-36, 30, and 71-73 are under examination herein.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 71-72 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 71 require a “oily carrier”. This phrase is not present in the specification.
Claims 71-73 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a 12 month survival rate of 75% at ambient temperatures (instant specification 0092), does not reasonably provide enablement for any temperature. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Whether a disclosure satisfies the enablement requirement is assessed with respect to the factors set forth in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988); MPEP 2164.01 (a). These factors include: breadth of the claims, nature of the invention, state of the prior art, level of one of ordinary skill, level of predictability in the art, amount of direction provided by the inventor, existence of working examples and quantity of experimentation needed to make or use the invention.
All of the Wands factors have been considered with respect to the instant claims, and the most relevant factors are discussed in detail below.
Breadth of the claims/Nature of the invention
The elected species of the invention currently under examination is directed a capsule with probiotics exhibiting a 75% survival rate in 12 months. Thus, carrying out the invention requires a capsule with probiotics exhibiting a 75% survival rate in 12 months.
State of the prior art/Level of predictability
One of ordinary skill in the arts understands that a probiotic capsule can be subject to a wide range of temperatures, ranging from liquid nitrogen storage, to internal body temperature, to extreme heat (e.g., during transport). All of these temperature or changing from frozen to extreme heat would affect the viability of the microorganism in unpredictable ways.
Amount of direction provided/Existence of working examples
The instant specification discloses only probiotics exhibiting a 75% survival rate in 12 months at ambient temperatures. The specification does not provide any additional information, nor any structure-function relationship or other guidance that would allow one skilled in the art to determine such information.
Quantity of experimentation needed to make or use the invention
The claimed invention requires knowledge of how extreme temperatures and/or extreme temperature shifts affect encapsulated probiotics. Such information is not available in the prior art, As such, one of ordinary skill in the art would be required to undertake undue experimentation to carry out the claimed method.
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 71-72 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.
The term “oily carrier” in claim72 is a relative term which renders the claim indefinite. The term “oily carrier” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. No definition is provided for what constitutes an “oily carrier”. It is unclear if that refers to the feel of the carrier by hand or mouthfeel, or a specific amount of oil is needed to be added to become “oily”. One of ordinary skill in the arts would have different sensations when either touching or consuming a carrier that would rise to the level of “oily carrier”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 9-10, 15, 19, 24-26, and 30, are rejected under 35 U.S.C. 103 as being unpatentable over Naidu (US PAT 8758742) in view of Kabadi ( US PGPUB 20160022592) and Gehrman (US PAT 4518696) as evidenced by Madit (US 8795720) and Goldstein (Ellie J. C. Goldstein, Kerin L. Tyrrell, Diane M. Citron, Lactobacillus Species: Taxonomic Complexity and Controversial Susceptibilities, Clinical Infectious Diseases, Volume 60, Issue suppl_2, May 2015, Pages S98–S107).
Regarding claim 9, Naidu teaches an encapsulation system for probiotics comprising nitrogen-purge, instant bonding encapsulation method (oral delivery, title, abstract). Specifically, the encapsulation system comprises a composition comprising oil (carrier) and a probiotic, a two-piece capsule comprising a capsule cap and a capsule body; a gas to purge oxygen from the composition within the capsule (nitrogen, anaerobically inert); and a sealing solution to seal the capsule cap to the capsule body (Abstract, figure 5). The capsule can be a plant-based cellulose (column 15 lines 21-24). Naidu teaches the capsule can be hard with the probiotic suspended in oil (carrier) (column 7 lines 39-42) Naidu teaches that low water activity oils serve as biological preservatives (column 2 lines 38-39). Naidu teaches the probiotic is suspended in the oil (carrier) (claim 1). Naidu teaches the oil is an edible prebiotic oil (column 1 lines 18-23).
Naidu does not teach a suspending agent, claimed water activity, or seal of plant-based cellulose.
Gehrman teaches stabilized oral solutions of bacteria (title). Gehrman teaches that sunflower seed oil, when used as the liquid suspending medium for Lactobacillus cells (probiotic), results in a cell suspension manifesting a high degree of cell stability at room temperature (column 1 lines 55-59). While other highly unsaturated vegetable oils also tend to somewhat promote the stability of the Lactobacillus cells, sunflower seed oil appears to have unique properties in this respect (column 1 lines 59-63). Further, the cells can be maintained in suspension in the oil by incorporating a small amount of fumed silica (suspending agent) (column 1 lines 63-65). Gehrman teaches the silica should be in the agent range of 0.5%-2% (column 3 lines 45-50). By utilizing the sunflower seed oil medium together with the conditions and additives known to improve the stability of dry Lactobacilli, long term room temperature stability can be obtained (column 1 lines 56-68).
Gehrman does not teach the seal of plant-based cellulose.
Kabadi teaches an oral delivery system for probiotics (abstract). Kabadi teaches the use of HPMC for a capsule ([0137]), the sealed capsule containing a probiotic (claim 1), and band sealed HPMC capsules using HPMC for the sealing agent ([0176], [0178], and [320]). Band sealing is well understood in the art to be a means to externally seal a two piece capsule, and Kabadi specifically teaches the application of an aqueous or solvent coating of HPMC to seal the HPMC capsule ([0179]). HPMC can be a hard capsule as evidenced by Madit claim 1 (US patent 8,795,720 B2). Kabadi teaches “HPMC capsules have several advantages as they are made from non-animal materials, chemically stable, have low moisture content (protect lyophilized bacteria), less brittle even at low humidity (survive the GI transit), fast dissolution, biodegradable, no crosslinking and suitable to automatic capsules filling machines” ([0320]). Kabadi teaches that band sealing capsules is advantageous to avoid the need for excess moisture and heat required for processing which is especially important for maintenance of the viability of the biologicals; and minimize the impact on release of drug from the capsules ([0320]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Naidu by incorporating an oil with a suspension agent of Gehrman and use HPMC capsules as taught by Kabadi. One of ordinary skill in the art would be motivated to do so because Gehrman teaches the use of a suspending agent keeps cells in suspension improving stability and HPMC capsules have a variety of benefits as taught by Kabadi. There would be a reasonable expectation of success as Naidu, Gehrman, and Kabadi are in the same field of endeavor of delivery of probiotics.
Regarding claim 10, Kabadi teaches a HPMC capsule and HPMC seals to enclose a probiotic formulation ([0176] and [0178]).
Regarding claims 15 and 19, Naidu teaches Lactobacillus (claim 1), which is a classified as a facultative anaerobe as evidenced by Goldstein (s98 left column lines 7-10).
Regarding claim 24, Naidu teaches the use of soy oil, fish oil and olive oil to increase the growth of Lactobacillus (table 4). Gehrman teaches that sunflower seed oil, when used as the liquid suspending medium (carrier) for Lactobacillus cells, results in a cell suspension manifesting a high degree of cell stability at room temperature (column 1 lines 55-59).
Regarding claim 25, Gehrman teaches a suspending agent such as fumed silica can be used (column 3 lines 31-32). Gehrman teaches that fumed silica is important for the creation of a suspension with high cell viability (column 3 lines 54-58).
Regarding claim 26, Naidu teaches a nitrogen gas purging of the cap of a capsule and the gas bubble is sealed inside the two-piece capsule (figure 5).
Regarding claim 30, Naidu teaches that viscosity enhancers can provide improved anaerobic conditions for the probiotic organisms inside the capsule (column 18 lines 30-41). Naidu also teaches the composition of Lactobacilli in oil (table 4). While the viscosity of the Lactobacilli in oil is not measured by Naidu, a composition of oil and bacteria will necessarily have a measurable viscosity. Naidu further states that viscosity enhancers can be added to the composition in order to improve the dispersion of capsular contents and improve conditions for the probiotics (column 18 lines 38-41). This indicates to one of ordinary skill in the arts that the viscosity is a results effective variable and be motivated to experiment with the viscosity. "[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed.Cir.1999). “[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) (MPEP 2144.05).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Naidu in view of Kabadi and Gehrman as applied to claims 9, 10, 15, 19, 24-26, 30, 71 and 72 above, and further in view of Stegemann (Sven Stegemann, Sudershan Vishwanath, Ravi Kumar, Dominique Cade, Missy Lowery, Keith Hutchison, Michael Morgen, Aaron Goodwin and Chang Lee Comparative human in-vivo study of an immediate release tablet over-encapsulated by gelatin and hydroxypropyl methyl. 2015).
Regarding claim 14, Kabadi teaches a HPMC capsule and HPMC seals to enclose a probiotic formulation ([0176] and [0178]). Kabadi also teaches the use of carrageenan as a polymer for live enzyme encapsulation (p9 left column line 1). Kabadi teaches water as part of the final HPMC capsule ([0240, 0244]).
Kabadi does not teach potassium acetate as part of the capsule.
Stegemann teaches that potassium acetate is commonly used as part of the HPMC capsule as a gelling promoter (p2 left column lines 5-11).
It would be obvious to one of ordinary skill in the art at before the effective filing date of the claimed invention to modify the HPMC encapsulated probiotics as taught in Kabadi with the potassium acetate that is commonly used in HPMC capsules as taught by Stegemann. To one skilled in the arts it would be expected that an HPMC capsule contains water, carrageenan and potassium acetate as that is how that type of capsule is commonly made. Thus, one of ordinary skill in the arts would have a reasonable expectation of success in creating a probiotic composition enclosed in HPMC capsules that contain water, carrageenan and potassium acetate before the effective filing date of the claimed invention.
Below are the proposed examiner amendments that were put forth to place the application in condition for allowance.
9. A probiotic dosage form comprising:
a sealed, hard shell two piece capsule comprised of a plant-based cellulose,
a composition within the sealed capsule, the composition comprising a probiotic organism, a carrier comprising oil and having a water activity (aw) level at or below 0.5, and from about 1 to about 4 weight percent of a suspending agent, wherein the weight percent is based on the total weight of the composition, and wherein the probiotic organism is suspended directly in the carrier; and
an anaerobic inert gas within the sealed capsule;
wherein the seal is formed by applying a liquid composition comprising a plant- based cellulose externally of the two piece capsule
and wherein the probiotic dosage form exhibits a 12-month survival rate of 75% for the encapsulated probiotic organisms at ambient temperature.
32. (Currently amended) A method of promoting gut health in an animal comprising orally administering the probiotic dosage form according to claim 9 to the animal.
71. (Currently Amended) A probiotic dosage form comprising:
a sealed, hard shell two piece capsule comprised of a plant-based cellulose;
a composition within the sealed capsule, the composition consisting of one or more probiotic organisms suspended in a blend of (i) a carrier comprising oil and having a water activity (aw) level at or below 0.5, and (ii) one or more suspending agents selected from silica and lecithin; and
an anaerobic inert gas within the sealed capsule;
wherein the seal is formed by applying a liquid composition comprising a plant-based cellulose externally of the two piece capsule; and
wherein the probiotic dosage form exhibits a 12-month survival rate of 75% for the encapsulated probiotic organisms at ambient temperature.
72. (Currently Amended) The probiotic dosage form according to claim 71, wherein:
the one or more probiotic organisms are present in an amount of about 15 to about 65 weight percent,
the
the one or more suspending agent is present in an amount of from about 1 to about 4 weight percent,
wherein the weight percent is based on the total weight of the composition.
73. (Currently Amended) A probiotic dosage form comprising:
a sealed, hard shell two piece capsule comprised of a plant-based cellulose; and
a composition within the sealed capsule, which has a viscosity at 18°C of about 400 to about 700 centipoise, the composition consisting of:
one or more probiotic organisms, which are present in an amount of about 15 to about 65 weight percent based on the total weight of the composition, wherein the one or more probiotic organisms are suspended in a blend of:
a carrier selected from safflower oil and medium-chain triglycerides, which is present in an amount of from about 46 to 54 weight percent based on the total weight of the composition, and
one or more suspending agents selected from the group of soy lecithin, sunflower lecithin, silica, and mixtures thereof, which one or more suspending agents is present in an amount of from about 1 to about 4 weight percent based on the total weight of the composition; and
an anaerobic inert gas within the sealed capsule;
wherein the seal is formed by applying a liquid composition comprising a plant-based cellulose externally of the two piece capsule; and
wherein the probiotic dosage form exhibits a 12-month survival rate of 75% for the encapsulated probiotic organisms at ambient temperature.
Allowable Subject Matter
No prior art was found comprising the claimed dosage form exhibiting a 12-month survival rate of 75% for the encapsulated probiotic organisms at ambient temperature.
Response to Arguments
Applicant's arguments filed 10/24/25 have been fully considered but they are not persuasive. Applicant argues that each reference poses a different delivery method for the probiotics (p7 3rd full paragraph). All the references teach oral delivery, see the rejection of claim 9 above.
Applicant argues that there is no reasonable expectation of success (p7 3rd full paragraph). No changes to the functions of the respective ingredients would be needed. One skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.
Conclusion
No claims are allowed.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657