DETAILED ACTION
Claims 1-19 are pending. Of these, claims 12-19 are withdrawn as directed to a nonelected invention. Therefore, claims 1-11 are under consideration on the merits.
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 .
Restriction
Applicant’s election of Group I, claims 1-11, with traverse is acknowledged. The basis of the traversal is that the searches for the two groups of inventions would be the same.
In response, this is not persuasive because the product of Group I could be produced by a materially different process than that recited by Group II and is therefore properly subject to restriction as discussed in the restriction requirement. The election requirement is still considered proper and is made FINAL.
Applicant’s election of phosphatidylcholine as the species of phospholipid, beta-carotene and cholesterol in combination as the isoprenoids, and maltodextrin as the water-soluble carrier, is acknowledged. The elections having been made without traverse, the election requirement is still considered proper and is made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/21/2024 and 11/11/25 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner. One reference, however, was not considered as it is not in English and no translation or concise statement of relevance was provided.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites “the microsphere,” but there is no antecedent basis for this limitation. Additionally, the claim recites “seed,” and “live probiotics,” but it is unclear whether these are references to the “seed layer” and “probiotics layer” recited by claim 1. Additionally, the claim recites “protein,” and “minerals,” but base claim 1 does not recite protein or minerals. If protein and minerals are an additional ingredient in the claim 9 composition, the claim should recite “further comprising protein and minerals.” Additionally, the claim recites “polymer,” which is indefinite because claim 1 recites “one or more pH-responsive polymers” as well as a polysaccharide (which is a polymer), and it is unclear which polymer is being referred to in claim 9. Clarification is required.
Claim 11 recites “the probiotic core,” but there is no antecedent basis for this limitation in base claim 1, which only recites a ”synbiotic core.” Clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, and 11 are rejected under 35 U.S.C. 103 as unpatentable over Zorea (US Pat. Pub. 2011/0008493) in view of CN113892650 as evidenced by the English translation thereof, Forssen et al. (Advanced Drug Delivery Reviews 29 (1998) 249-271), and Andreeva et. Al. (Journal of Physics: Conference Series 253 (2010),
As to claims 1-3, 5, and 11¸ Zorea discloses a heat resistant probiotic particle comprising a core comprising probiotic bacteria layer coated onto a substrate, an inner layer of vegetable oil, and two outer polymer layers (claim 1 of Zorea), wherein one of the layers comprises a pH responsive polymer such as methacrylic acid and methylmethacrylate copolymer (the elected species of pH responsive polymer of claims 1 and 5)(paragraph 16), and the other, outer layer is a heat resistant layer comprising a heat resistant polysaccharide such as starch, pullulan, or chitosan (paragraph 20). The substrate in the core comprises a cellulose (a polysaccharide of claims 1 and 2)(paragraphs 9, 24). The particle has a mean diameter of 0.1-1000 microns (paragraph 16), which encompasses the range of claim 1. Zorea teaches that its three layer particle advantageously provides probiotics that have high heat stability (paragraphs 10 and 16). Zorea also teaches that an additional intermediate layer may be incorporated between the pH-responsive polymer layer and the outer heat resistant layer for the purpose of preventing direct contact between the pH responsive layer and the outer layer that could result in an undesired interaction (paragraphs 16, 19).
Regarding claim 3, the probiotic may be the elected species, Lactobacillus (claim 7 of Zorea).
As to claims 1-3, 5, and 11, Zorea does not further expressly disclose that the particle comprises a heat resistant bilayer shell over the acid resistant layer comprising an inner shell comprising an isoprenoid stabilized phospholipid liposome and an outer layer comprising a disaccharide or polysaccharide as recited by claim 1 and wherein the phospholipid is the elected species, i.e. phosphatidyl choline and the isoprenoid is the elected species, i.e., a combination of beta-carotene and cholesterol (claim 6). Nor does Zorea expressly teach that the particle resists a temperature of up to 90 degrees Celsius for up to 15 minutes without releasing the probiotics core as recited by claim 11.
CN113892650 discloses that to achieve the benefits of probiotics, they must remain active and metabolically stable, but they have problems tolerating the acidic environment of the stomach (paragraph 2), which can be solved by encapsulating the probiotics in phospholipid liposomes (paragraph 4).
Andreeva discloses the integration of beta-carotene into liposomes, and teaches that beta-carotene contributes to the stability of the lipid phase of membranes, and can easily be incorporated into phosphatidyl choline liposomes (Abstract).
Forssen discloses that the presence of cholesterol in phospholipid liposomes plays an important role in enhancing stability against leakage and in minimizing phospholipid exchange (page 256,1st full paragraph).
As to claims 1-3, 5, and 11, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the composition of Zorea by incorporating a beta-carotene and cholesterol-stabilized phospholipid liposome between the pH responsive layer and the outer polysaccharide layer so as to form an acid-resistant bilayer shell, because CN113892650 discloses that probiotics have problems tolerating the acidic environment of the stomach which can be solved by encapsulating the probiotics in phospholipid liposomes, such that the skilled artisan reasonably would have expected that incorporating a liposome into the Zorea particle would enhance the ability of the probiotics to tolerate the acidic stomach environment, and because Andreeva and Forssen teach that incorporating beta carotene and cholesterol into liposomes will advantageously improve their stability. The skilled artisan would have been further motivated to place the liposome layer between the pH responsive layer and the outer heat resistant polysaccharide layer because Zorea expressly suggests incorporating an additional optional layer in that location to prevent unwanted interactions between these two layers.
Regarding claim 11, the resulting modified prior art particle will resist a temperature of up to 90 degrees Celsius for up to 15 minutes without releasing the probiotics core based upon the evidence of record because it comprises the same ingredients recited by the claims and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Claims 4 and 8 are rejected under 35 U.S.C. 103 as unpatentable over Zorea (US Pat. Pub. 2011/0008493) in view of CN113892650 as evidenced by the English translation thereof, Forssen et al. (Advanced Drug Delivery Reviews 29 (1998) 249-271), and Andreeva et. Al. (Journal of Physics: Conference Series 253 (2010)) as applied to claims 1-3, 5, and 11 above, and further in view of Penhasi (US Pat. Pub. 2013/0323362).
The teachings of Zorea, CN113892650, Forssen and Andreeva are relied upon as discussed above, and Zorea further teaches incorporating silicon dioxide into the outer heat-resistant layer as a glidant (paragraphs 39, 43), which is one of the minerals recited by claim 8, but is not the elected species of mineral, i.e., talc. Zorea also does not disclose the presence of one of the ingredients recited by claim 4 in the probiotic layer, such as fructooligosaccharides, galactosaccharides, or inulin.
Penhasi discloses multilayered particles comprising a core comprising probiotics for delivery (Abstract), and discloses an embodiment comprising the mineral talc in the outer layer as the glidant (paragraph 95). Penhasi further teaches mixing a sugar such as fructooligosaccharides, galactosaccharides, or inulin into the core to serve as a nutritional agent for the probiotics (paragraphs 47-48).
Regarding claim 4, it would have been prima facie obvious to incorporate fructooligosaccharides, galactosaccharides, or inulin into the probiotic layer of the particle of Zorea, CN113892650, Forrsen, and Andreeva as combined supra, because Penhasi teaches that it is beneficial to include these compounds in a probiotic composition because they provide nourishment to the probiotics.
As to claim 8, it further would have been prima facie obvious to modify the particle of Zorea, CN113892650, Forrsen, and Andreeva as combined supra by selecting talc as the mineral glidant in the outer layer instead of, or in addition to, the silicon dioxide mineral glidant taught by Zorea, because Penhasi demonstrates that it was known to use talc as the mineral glidant in the outer polymeric coating over a probiotics particle. Such a modification is merely the simple substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Claims 6-7 and 9 are rejected under 35 U.S.C. 103 as unpatentable over Zorea (US Pat. Pub. 2011/0008493) in view of CN113892650 as evidenced by the English translation thereof, Andreeva et. al. (Journal of Physics: Conference Series 253 (2010) and Forssen et al. (Advanced Drug Delivery Reviews 29 (1998) 249-271) as applied to claims 1-3, 5, and 11 above, and further in view of Etzbach et al. (Current Research in Food Science 3(2020) 73-81).
The teachings of Zorea, CN113892650, Andreeva, and Forssen are relied upon as discussed above, and Zorea further teaches that the particle may comprise protein in a layer as recited by claim 9 (paragraph 19) and that the saccharide in the outer shell layer may be a modified cellulose (paragraph 20), but these references do not further expressly disclose the presence of a water soluble carrier in the inner shell layer as recited by claim 6 and that is the elected species (i.e., maltodextrin), or that the saccharide in the outer shell is one of those recited by claim 7, such as cellobiose, or that the particle comprises a disaccharide as recited by claim 9. Additionally, these references do not expressly disclose the amounts of the seed probiotics, protein, polymer, liposome, polysaccharide, disaccharides, and minerals recited by claim 9.
Etzbach discloses that maltodextrin and cellobiose (a cellulose derivative that is a “disaccharide” of claim 9) can protect carotenoids from degradation due to light, high temperature, and oxygen (Abstract and last paragraph on page 78).
As to claims 6-7 and 9, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the probiotic particle of Zorea, CN113892650, Andreeva, and Forssen as combined supra by incorporating maltodextrin into the liposome layer containing the beta-carotene and the disaccharide cellobiose into the outer shell layer over the carotene-containing liposome layer, because Etzbach discloses that these compounds can shield carotenoids from degradation due to light, high temperature, and oxygen.
Regarding the amounts of the ingredients recited by claim 9, it would have been prima facie obvious to arrive at the recited amounts with a reasonable expectation of success because these ingredients are being used in the cited prior art in a similar manner to obtain the same functionality as in the present claims based upon the evidence of record. Specifically, in both cases the seed is used as a solid carrier for the probiotics, the probiotic is used as the active agent for delivery, and the liposome, proteins, polymers and the polysaccharides/disaccharides are all used to protect the probiotics against degradation due to heat and acidic environments. Differences in concentration generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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). Here, there is no evidence of record of any unexpected criticalities from use of the recited amounts.
Regarding the recitation of claim 6 that the phospholipid of the inner shell is formed by “proliposomes,” this limitation renders claim 6 a product by process claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ( "a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim." ). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima face case of either anticipated or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Here, the structure of the liposome of the cited art as combined supra will possess the same structure as the inner shell layer of claim 6 based upon the evidence of record because it comprises the same ingredients arranged in the same configuration that is recited by the claim, i.e., a stabilized phospholid layer comprising phosphatidylcholine, beta-carotene, cholesterol, and maltodextrin as discussed above.
Claim 10 is rejected under 35 U.S.C. 103 as unpatentable over Zorea (US Pat. Pub. 2011/0008493) in view of CN113892650 as evidenced by the English translation thereof, Andreeva et. al. (Journal of Physics: Conference Series 253 (2010) and Forssen et al. (Advanced Drug Delivery Reviews 29 (1998) 249-271) as applied to claims 1-3, 5, and 11 above, and further in view of Talebian et. al. (Adv. Healthcare Mater. 2022, 11, 2102487; published 2.21.2022).
The teachings of Zorea, CN113892650, Andreeva, and Forssen are relied upon as discussed above, but they do not further expressly disclose the presence of an additional water barrier coating layer coupled to the outer layer and comprising shellac and dimethylaminoethyl methacrylate copolymer.
Talebian is a review of multilayer microparticles comprising probiotics, and teaches that incorporating an outer shell into the microparticles comprising shellac results in higher cell viability of the probiotic after 60 days storage as a result of reduced porosity and improved resistance to acid (Title, Abstract, and last full paragraph of page 9). Talebian also teaches that a copolymer comprising dimethylaminoethyl methacrylate can also be used as a shell material for protecting encapsulated probiotics (last paragraph on page 7).
It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the encapsulated probiotic composition of Zorea, CN113892650, Andreeva, and Forssen as combined supra by incorporating an additional outer layer comprising shellac and a copolymer comprising dimethylaminoethyl methacrylate, because Talebian teaches that these polymers are useful as outer shell materials for protecting encapsulated probiotics resulting in higher cell viability during storage.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600