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 Status
2. The claims filed Dec. 4, 2025 are of record. Claims 3-4, 7-8, 12, 15, 17-29, 31, 34, 37 and 42 are cancelled.
Election/Restrictions
3. Applicant’s election without traverse of Group A in the reply filed on December 4, 2025 is acknowledged. Claims withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 4, 2025. Claims 1-2, 5, 10-11, 13, 30 and 35 are under consideration in this Office Action.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on March 28, 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
5. Claim 5 is 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. This is a deposit rejection.
The specification lacks complete deposit information for the deposit of Acetobacter xylinum, preferably from the strain deposited at the Colección Española de Cultivos Tipo (CECT) with accession number CECT 473. Because it is not clear that cell lines possessing the properties of Acetobacter xylinum, preferably from the strain deposited at the Colección Española de Cultivos Tipo (CECT) with accession number CECT 473 are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims require the use of Acetobacter xylinum, preferably from the strain deposited at the Colección Española de Cultivos Tipo (CECT) with accession number CECT 473, a suitable deposit for patent purposes is required. Without a publicly available deposit of the above cell line, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the cell line is an unpredictable event.
If a deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of deposit and the complete name and full street address of the depository is required.
If the deposit has not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1) The name and address of the depository;
2) The name and address of the depositor;
3) The date of deposit;
4) The identity of the deposit and the accession number given by the depository;
5) The date of the viability test;
6) The procedures used to obtain a sample if the test is not done by the depository; and
7) A statement that the deposit is capable of reproduction.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the bacterial cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
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.
6. Claims 1-2, 5, 30 and 35 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, 30 and 35 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 o 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.
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.
7. Claims 1-2, 10-11, 30 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.
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 claims 30 and 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.
Claim Rejections - 35 USC § 102
8. Claims 1-2, 10-11, 30 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 claimed are anticipated.
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.
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, 30 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.
Pertinent Art
8. 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
9. No claims allowed.
10. 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 Vanessa Ford, can be reached on 571-272-0857. 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