DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Amendment
2. The amendment filed July 15, 2026 have been entered. Claim 1 has been amended. Claim 44 was newly added. Claims 6, 9, 14, 16, 32-33, 36, 38-41 and 43 are withdrawn from consideration. Claims 3-4, 7-8, 12, 15, 17-31, 34, 37 and 42 are cancelled.
Withdrawal of Claim Rejections
3. The deposit rejection of rejection of claim 5 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of Applicants statements regarding the public availability of the CECT 473.
4. The rejection of claim 30 under 35 U.S.C. 101 is withdrawn in view of Applicants amendment and cancellation of the claim.
5. The rejection of claim 30 under 35 U.S.C. 102(a)(1) as being anticipated by Phromthep et al., is withdrawn in view of Applicants amendment and cancellation of the claim.
6. The rejection of claim 30 under 35 U.S.C. 102(a)(1) as being anticipated by CN102031248 is withdrawn in view of Applicants amendment and cancellation of the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
7. Claims 1-2, 5, 35 and 44 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1-2, 5, 35 and 44 are determined to be directed to natural products and do not recite something “significantly different” than the natural product. Natural products are “judicial exemptions”. The rationale for this determination is explained below.
The claims are drawn to a biomaterial comprising a bacterial cellulose matrix and probiotics entrapped in said matrix, wherein the biomaterial is essentially free from bacteria that produce cellulose. The bacterial cellulose matrix and probiotic are not “markedly different” in structure than naturally occurring bacterial cellulose matrix and probiotic such as Lactobacillus or the Bifidobacterium. Acetobacter xylinum CECT 473 (now Komagataeibacter xylinus) is a well-known, naturally occurring acetic acid bacterium found in sugary environments like rotten fruit and vinegar, famous for producing high-purity bacterial cellulose (BC), a pure form of cellulose similar to plant cellulose but without lignin, used in various foods (like nata de coco) and advanced biomaterials. Bacterial cellulose (BC) is a completely natural polymer produced by certain bacteria, like Komagataeibacter xylinus, forming pure, strong nanofibrils that serve as protective extracellular structures in nature, found in diverse environments from soil to fruit, though it's now also grown in labs for high-tech uses in medicine, textiles, and more due to its unique purity, strength, and water-holding capacity compared to plant cellulose. Natural probiotics are beneficial live microorganisms, like good bacteria and yeasts, found in fermented foods that support gut health, digestion, and immunity by balancing the gut's microbial ecosystem. For instance, Lactobacillus is a lactic acid bacterium naturally found in the gastrointestinal tract and vagina. Lactobacillus is considered a probiotic--a live microorganism that may benefit health when consumed. Thus, all of the ingredients are therefore not markedly different from their counterparts found in nature.
These claims fail to satisfy the non-naturally occurring requirement. Furthermore, there is no structural difference because of the mere aggregation of natural occurring bacterial cellulose and a probiotic together as a product; the product does not change the structure of the naturally occurring cellulose and probiotic.
Additionally, the product claims as a whole do not recite something significantly different from the judicial exceptions because the additional components do not impose meaningful limits on the claim scope therefore substantially all practical applications of the judicial exception are covered. Furthermore, the additional elements in dependent claims such as inclusion of additional ingredients, like carriers are all recited at a high level of generality, and/or are well-understood, purely conventional and routine in the field, and/or are merely appended to the judicial exception without a significant change in the structure of the judicial exception itself as evidenced by the prior art recited within the rejections.
If the applicant chooses to amend the instant claims, the examiner recommends that applicant consider the U.S. Supreme Court ruling that the additional steps should consist of more than well-understood, routine, conventional activity already engaged in by the scientific community. Such putative additional steps, when viewed as a whole, might add nothing significant beyond the sum of their parts taken separately. The Court has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words "apply it." Essentially, appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.
The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June 13, 2013). Also see the December 4, 2014 and May 4, 2016 Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products (the Guidance).
Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are held to claim a law of nature and natural products, and are therefore rejected as ineligible subject matter under 35 U.S.C. 101.
Response to Arguments
8. Applicant's arguments filed July 15, 2026 have been fully considered but they are not persuasive. Applicants assert that product by process claims bring together pre-existing natural materials to create a new biomaterial. However, the “new biomaterial” was created by the aggregation of natural products does not overcome the rejection. There is no indication in the specification that the claimed mixture of bacteria and natural products have any characteristics (structural, functional, or otherwise) that are different from the naturally occurring bacteria or cellulose. Thus, the mixture does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A: YES). Because the claim does not include any additional features that could add significantly more to the exception (Step 2B: NO), the claim does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101. The inoculant of claim 1 was held to be ineligible subject matter in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948): Discovery of the fact that the bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities. It is no more than the discovery of some of the handiwork of nature and hence is not patentable. The aggregation of the bacteria and cellulose is an application of that newly-discovered natural principle. But however ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants. The bacteria and cellulose acquired no different use. The combination of produces no new bacteria, no change in the bacteria, and no enlargement of the range of either the bacteria or cellulose’s utility. Each species has the same effect it always had. The bacteria and cellulose perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee. Recently, the Supreme Court looked back to this claim as an example of ineligible subject matter, stating that “the composition was not patent eligible because the patent holder did not alter the bacteria in any way.” Myriad, 133 S. Ct. at 2117. Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
9. Claims 1-2, 10-11 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Phromthep et al., (International Food Research Journal 24(3): June 2017).
The claims are drawn to a biomaterial comprising a bacterial cellulose matrix and probiotics entrapped in said matrix, wherein the biomaterial is essentially free from bacteria that produce cellulose and method of production cellulose, and wherein the biomaterial is obtained by a method comprising:
(i) culturing aerobic bacteria that produce cellulose simultaneously with facultative anaerobic probiotics and/or aerotolerant anaerobic probiotics under aerobic conditions suitable for the production of cellulose by the bacteria that produce cellulose, thereby resulting in a cellulose matrix containing the bacteria and the probiotics, and
(ii) incubating the cellulose matrix obtained in step (i) in a culture medium that provides anaerobic conditions which are suitable for the proliferation of the probiotics in said matrix and which are not suitable for the proliferation of the aerobic bacteria.
It is noted that MPEP 2113 recites product by process claims are not limited to the manipulations of the recited steps only the structure implied by the steps.
Phromthep et al., disclose bacterial cellulose production via fermentation with Acetobacter xylinum [abstract]. Bacterial cellulose is a final product of carbon metabolism synthesized by a strain of acetic acid bacteria group also called Gluconobacter xylinus (formerly called Acetobacter xylinum) [Introduction].
Selected probiotic strain identified as Lactobacillus plantarum was immobilized within suitable bacterial cellulose cubes. The survivals of free L. plantarum cells (control) and immobilized L. plantarum ones within different bacterial cellulose cubes in mamao juice samples were analyzed [abstract]. Thus teaching claim 35. Therefore, an approach to extend the viability of probiotic living cells and the application of immobilized cells with polymer to protect the probiotic cells with a physical barrier against adverse environmental conditions are currently receiving considerable interest. The advantages of cell immobilization are for example, good stability, easy recycling, durability, high functional efficiency, as well as the resistance to the detrimental environmental factors such as temperature, pH, and toxic substances [Introduction]. This study was aimed to apply the bacterial cellulose produced from different substrates including mature coconut water and mamao fruit residues by fermentation with Acetobacter xylinum TISTR 893 for probiotic immobilization and determine the probiotic survivability in mamao juice during refrigerated storage along with the product sensory analysis [Introduction]. Thus teaching claims 1-2 and 35 the saline is a pharmaceutically acceptable carrier.
For the preparation of bacterial cellulose, Acetobacter xylinum was inoculated into the sterile glucose medium. The inoculated medium was then incubated at 37°C for 7 days before scaling up [Preparation of bacterial cellulose]. After incubation, the bacterial cellulose pellicles were formed and these pellicles were harvested and washed by distilled water to eliminate sour taste and cut into small cubes. The bacterial cellulose cube samples were washed again to remove the medium or bacterial residues and the cubes were sterilized [Preparation of bacterial cellulose]. These probiotic cells were used as free cells and immobilized cells within supports. Probiotic immobilization was achieved by resuspending the cells in sterile saline solution. Then, the prepared bacterial cellulose cubes were mixed with probiotic cells suspension and incubated. At the end of the incubation period, the immobilized bacterial cellulose cubes were aseptically removed and washed by sterile saline solution for three times and the samples were kept under cold storage [Preparation of free and immobilized probiotic cells]. Thus teaching claims 10-11. Therefore, the instantly rejected claimed are anticipated.
Response to Arguments
10. Applicant's arguments filed July 15, 2026 have been fully considered but they are not persuasive. Applicants argue that the claims recite a culturing step and incubation step which results in a deliberate sequence of culture conditions. However, Applicants are reminded that the claims are drawn to a product and not to the newly recited method steps. Moreover, Applicants arguments do not identify a single ingredient
Applicants attention is directed to MPEP 2113. Applicants are reminded that Product by Process claims are not limited to the manipulations if the recited steps, only the structure implied by the steps. “[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. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020) (“Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims.”); United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023) (the court held that product-by-process claims were properly rejected as “anticipated by a disclosure of the same product irrespective of the processes by which they are made.”); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). 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”).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (holding “interbonded by interfusion” to limit structure of the claimed composite and noting that terms such as “welded,” “intermixed,” “ground in place,” “press fitted,” and “etched” are capable of construction as structural limitations). See also In re Nordt Dev. Co., 881 F.3d 1371,1375-76, 125 USPQ2d 1817, 1820 (Fed. Cir. 2018)(holding “the specification demonstrates that ‘injected molded’ connotes an integral structure,” and discussing several cases since Garnero that held “limitations to convey structure even when they also describe a process of manufacture”).
It is noted, that Applicants only argue that the Phromthep et al., do not disclose the newly recited culturing and incubation steps; yet does not argue that the Phromthep et al’s biomaterial comprises different components than those instantly claimed. Therefore in this case, Phromthep et al., clearly teach the instantly claimed biomaterial comprising a bacterial cellulose matrix and probiotics entrapped in said matrix, wherein the biomaterial is essentially free from bacteria that produce cellulose.
Furthermore, Applicants argue that the reference does not disclose probiotics entrapped in a bacterial cellulose matrix. These probiotic cells were used as free cells and immobilized cells within supports. Probiotic immobilization was achieved by resuspending the cells in sterile saline solution. Then, the prepared bacterial cellulose cubes were mixed with probiotic cells suspension and incubated. At the end of the incubation period, the immobilized bacterial cellulose cubes were aseptically removed and washed by sterile saline solution for three times and the samples were kept under cold storage. Thus, the argument is not found persuasive.
Moreover, for the preparation of bacterial cellulose, Acetobacter xylinum was inoculated into the sterile glucose medium. The inoculated medium was then incubated at 37°C for 7 days before scaling up [Preparation of bacterial cellulose]. After incubation, the bacterial cellulose pellicles were formed and these pellicles were harvested and washed by distilled water to eliminate sour taste and cut into small cubes. The bacterial cellulose cube samples were washed again to remove the medium or bacterial residues and the cubes were sterilized [Preparation of bacterial cellulose]. These probiotic cells were used as free cells and immobilized cells within supports. Probiotic immobilization was achieved by resuspending the cells in sterile saline solution. Then, the prepared bacterial cellulose cubes were mixed with probiotic cells suspension and incubated. At the end of the incubation period, the immobilized bacterial cellulose cubes were aseptically removed and washed by sterile saline solution for three times and the samples were kept under cold storage [Preparation of free and immobilized probiotic cells]. Thus teaching (i) culturing aerobic bacteria that produce cellulose simultaneously with facultative anaerobic probiotics and/or aerotolerant anaerobic probiotics under aerobic conditions suitable for the production of cellulose by the bacteria that produce cellulose, thereby resulting in a cellulose matrix containing the bacteria and the probiotics, and (ii) incubating the cellulose matrix obtained in step (i) in a culture medium that provides anaerobic conditions which are suitable for the proliferation of the probiotics in said matrix and which are not suitable for the proliferation of the aerobic bacteria. Therefore, Applicants arguments are not found persuasive and the rejection is maintained.
Claim Rejections - 35 USC § 102
11. Claims 1-2, 10-11 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN102031248 (published April 30, 2014).
CN102031248 teach the microbial live bacterium agent is prepared by a microbial agent preparation process and by taking bacterial cellulose as a freeze-drying protective agent and carrier; the preparation method for the microbial live bacterium agent comprises the following steps of: preparing the bacterial cellulose into particles, adding the particles into a microbiological culture medium, uniformly stirring and mixing the particles, and then inoculating microorganisms and culturing; separating the bacterial cellulose particles under the aseptic condition, and washing the bacterial cellulose particles with sterile distilled water; and freezing and drying the bacterial cellulose particles, then crushing the particles into powder, and finally packaging the powder under the aseptic condition. The microbial live bacterium agent provided by the invention can effectively protect the activity of lactic acid bacteria; and the microorganisms still have high activity [abstract]. The included probiotic is lactobacillus bulgaricus and/or bifidobacterium bifidum is cultivated down; and skim-milk is added as lyophilized vaccine [Embodiment three]. Therefore, the instantly rejected claims are anticipated.
Response to Arguments
12. Applicant's arguments filed July 15, 2026 have been fully considered but they are not persuasive. Applicants argue that the claims recite a culturing step and incubation step which results in a deliberate sequence of culture conditions. However, Applicants are reminded that the claims are drawn to a product and not to the newly recited method steps. Moreover, Applicants arguments do not identify a single ingredient
Applicants attention is directed to MPEP 2113. Applicants are reminded that Product by Process claims are not limited to the manipulations if the recited steps, only the structure implied by the steps. The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.
It is noted, that Applicants only argue that the CN102031248 do not disclose the newly recited culturing and incubation steps and does not argue that the CN102031248’s biomaterial comprises different components than those instantly claimed. Therefore in this case, CN102031248 clearly teach the instantly claimed biomaterial comprising a bacterial cellulose matrix and probiotics entrapped in said matrix, wherein the biomaterial is essentially free from bacteria that produce cellulose. CN102031248 teach the microbial live bacterium agent is prepared by a microbial agent preparation process and by taking bacterial cellulose as a freeze-drying protective agent and carrier; the preparation method for the microbial live bacterium agent comprises the following steps of: preparing the bacterial cellulose into particles, adding the particles into a microbiological culture medium, uniformly stirring and mixing the particles, and then inoculating microorganisms and culturing; separating the bacterial cellulose particles under the aseptic condition, and washing the bacterial cellulose particles with sterile distilled water; and freezing and drying the bacterial cellulose particles, then crushing the particles into powder, and finally packaging the powder under the aseptic condition. Therefore, Applicants arguments are not found persuasive and the rejection is maintained.
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.
13. Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Phromthep et al., (International Food Research Journal 24(3): June 2017) OR
CN102031248 (published April 30, 2014) as applied to claims 1-2, 10-11 and 35 above, and further in view of Raghunathan (International J of Current Microbio and Applied Sciences. Volume 2 Number 12 (2013) pp.275-290).
CN102031248 teach a biomaterial comprising a bacterial cellulose matrix
and probiotics entrapped in said matrix, wherein the biomaterial is essentially free from bacteria that produce cellulose and method of production, but does not teach the matrix is produced by Acetobacter xylinum CECT 473 also deposited as ATCC 11142.
Raghunathan teach cellulose is the most abundant natural biopolymer on the earth. It is also produced by some bacteria. Bacterial cellulose (BC) is chemically pure and free of lignin and hemi-cellulose. BC has high crystallinity and a high degree of polymerization. Microbial cellulose is an exopolysaccharide produced by various species of bacteria, such as Gluconacetobacter (formerly Acetobacter), Agrobacterium, Aerobacter, Achromobacter, Azotobacter, Rhizobium, Sarcina, and Salmonella. Bacterial cellulose has important applications in a variety of food formulations, lack of flavor interactions, foam stabilization, and stability over a wide range of pH, temperature, and freeze-thaw conditions are required. Potential uses include pourable and spoonable dressings, sauces, and gravies; frostings and icings; sour cream and cultured dairy products; whipped toppings and desserts, and frozen dairy products and wound care products and tissue and organ engineering. Raghunathan teach low cost environmentally friendly production of cellulose [Introduction]. BC is highly porous material, which allows transfer of antibiotics or other medicines [Introduction]. Acetobacter xylinum produces two forms of cellulose: 1) cellulose 1, the ribbon like polymer, and 2) cellulose 2, the thermodynamically more stable amorphous polymer [Introduction]. A. xylinum has been applied as a model microorganism for basic and applied studies on cellulose. It is most commonly studied source of bacterial cellulose because of its ability to produce relatively high levels of polymer from a wide range of carbon and nitrogen sources [Introduction]. Raghunathan teach A. xylinum ATCC 11142 was supplied by IMTECH.
Therefore, it would have been prima facie obvious at the time of applicants’ invention to apply Raghunathan Acetobacter xylinum CECT 473 also deposited as ATCC 11142, into Phromthep et al., or CN102031248 bacterial matrix in order to produce cellulose with the model microorganism for cellulose, because of its ability to produce relatively high levels of polymer from a wide range of carbon and nitrogen source. One of ordinary skill in the art would have a reasonable expectation of success by incorporating the bacterial cellulose producer because it produces multiple forms of highly porous cellulose which allows for incorporation of other medicines, like the probiotics of Phromthep et al., or CN102031248. Finally, it would have been prima facie obvious to combine the teachings of Raghunathan Acetobacter xylinum CECT 473 also deposited as ATCC 11142, into Phromthep et al., or CN102031248 matrix to advantageously produce low cost environmentally friendly production of cellulose.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take a bacterial cellulose matrix produced by the well-known Acetobacter xylinum CECT 473 also deposited as ATCC 11142, wherein there is no change in the respective function of the bacteria or probiotic, thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Therefore, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
12. Applicant's arguments filed July 15, 2026 have been fully considered but they are not persuasive. Applicants argue that there is no objective, motivation or suggestion to modify either Phromthep et al., or CN102031248 methods to entrap the probiotics in the bacterial cellulose matrix. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been prima facie obvious at the time of applicants’ invention to apply Raghunathan Acetobacter xylinum CECT 473 also deposited as ATCC 11142, into Phromthep et al., or CN102031248 bacterial matrix in order to produce cellulose with the model microorganism for cellulose, because of its ability to produce relatively high levels of polymer from a wide range of carbon and nitrogen source. The Office sets forth that one of ordinary skill in the art would have a reasonable expectation of success by incorporating the bacterial cellulose producer because it produces multiple forms of highly porous cellulose which allows for incorporation of other medicines, like the probiotics of Phromthep et al., or CN102031248. Thus, Applicants arguments are not found persuasive and the rejection is maintained.
Pertinent Art
13. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Acetobacter xylinum CECT 473 refers to a specific strain of bacteria, now officially known as Komagataeibacter xylinus CECT 473, famous for its high production of pure bacterial cellulose (BC). This strain (also ATCC 11142, NCIMB 5346) is a model organism in research, used to create advanced nanomaterials for applications in tissue engineering, food science, and biomedicine due to its unique, strong, and biocompatible cellulose.
Park et al., (US6808703) Acetobacter is a strict aerobe but has characteristics of surviving and living under the condition of infinitesimal oxygen, and of being floated to seek for oxygen by means of synthesizing cellulose dietary fiber itself under this condition of infinitesimal oxygen. According to the research regarding the amount and rate of converting glucose into cellulose dietary fiber by Acetobacter (Brown et al.: Proc. Natl. Acad. Sci. USA, Vol73 (12), 4565-4569), Acetobacter converts glucose into cellulose.
JPH10146198 (published 1998-06-02) Bacteria cellulose is useful for viscosity retention of cosmetics and paints or for reinforcement of dough or paste as a raw material for food products in high yield by culturing a cellulose-producing microorganism in a culture medium to which a cellulose formation-promoting factor, for example, choline phosphoglyceride, is admixed [abstract]. SOLUTION: A cellulose-producing microorganism (for example, Acetobacter xylinum sp. nonacetoxydance is cultured in a culture medium [abstract]. This bacterial cellulosic product is edible, dispersible in water, and biodegradable and is useful for viscosity retention of food products, cosmetics, paints or the like, moisture retention, increase in the dough or paste for food raw materials, food product stability, a low calorie additive or an emulsion stabilizer [abstract].
Medoff (AU2016225857 published Sept 22, 2016) Medoff a method of producing bacterial cellulose further including direct fed organisms/probiotics (e.g., Aspergillus niger, Bacillus subtilis, Bifidobacterium animalis, B. bifidium, Enterococcus faecium, Aspergillus oryzae, Lactobacillus acidophilus, L. bulgaricus, L. planetarium, Streptococcus lactis, and Saccharomyces cerevisiae).
Khorasani et al. (Food Hydrocolloids. 2017, 63, 273). Khorasani teaches bacterial nanocellulose biomaterials as novel protective matrices for the delivery of microorganisms to the gastrointestinal system (Abstract). Probiotics, which are taught to play a role in the health of the gastrointestinal system, encounter difficulty reaching the colon due to “the harsh conditions associated with product processing and transit through the gastrointestinal tract” (pg. 273, right column, para. 1). Khorasani found that probiotic cells enclosed in a bacterial nanocellulose (BNC)-pectin bionanocomposite exhibited increased survivability through gastrointestinal digestion, likely due to the small pore size of the BNC-pectin matrix which protects probiotics against enzymatic breakdown and premature probiotic release (pg. 274, left column, para. 3).
Tronsder et al., (ACS Applied Materials & Interfaces 2018 10 (19), 16260-16269) teach the nanofibrous bacterial cellulose (BC) membrane derived from Komagataeibacter xylinus (KX) ATCC 11142, purchased from CCECT Spain, can inhibit the differentiation of mouse embryonic stem cells (mESC) under long-term conditions.
See also CN1766085.
Conclusion
14. No claims allowed.
15. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
16. . Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Peter Paras, can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645
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