DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment to the claims, filed August 26, 2026, is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Claims 1, 3-10, 13, 14, 19, and 22-29 are pending in the application and are being examined on the merits.
Applicant’s remarks filed August 26, 2026 in response to the non-final rejection filed June 4, 2026 have been fully considered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Terminal Disclaimer
The terminal disclaimer filed on August 26, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Number 17/625,955 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 112(a)
Claims 1, 3-10, 13, 14, 19, and 22-29 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
This rejection has been modified from its previous version in order to address applicant’s amendments to the claims.
MPEP § 2163.II.A.3.(b) states, “when filing an amendment an applicant should show support in the original disclosure for new or amended claims”. See also MPEP 714.02. MPEP § 2163.II.A.3.(b) further states, “[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, para. 1, as lacking adequate written description”. According to MPEP § 2163.I.B, “While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure” and “The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117”.
Claim 1 (claims 3-10, 13, 14, 22, 24, 26, and 28 dependent therefrom) recites the limitation “wherein the microorganism component of the microorganism loaded multiphase biomaterial comprising nanocellulose retains viability for at least six months when stored at room temperature, wherein the viability is measured by an assay comprising culturing the microorganism-loaded multiphase biomaterial in MRS broth medium TSB medium and measuring optical density at OD600 relative to the McFarland standard” and claim 19 (claims 23, 25, 27, and 29 dependent therefrom) recites the limitation “wherein the microorganism component of the microorganism loaded multiphase biomaterial comprising nanocellulose retains viability for at least six months when stored at room temperature, wherein the viability is measured by an assay comprising culturing the microorganism-loaded multiphase biomaterial in MRS broth medium or isotonic saline NaCl 0.9% and measuring optical density at OD600 relative to the McFarland standard.” However, there is no apparent descriptive support for the limitation “a humidity-impermeable aluminum compound foil” in the original application. Consequently, the applicant’s amendment filed is considered to introduce new matter into the claims.
RESPONSE TO REMARKS: At p. 8 of the instant remarks, applicant argues that paragraphs [0081], [0090], and [0132] of the published application (corresponding to the paragraph bridging pp. 11-12, the paragraph at p. 13, lines 8-20, and the paragraph at p. 20, lines 25-36, respectively, of the substitute specification filed November 15, 2024) provide descriptive support for the limitations at issue. However, without further explanation from the applicant, it is not apparent to the examiner as to how the cited paragraphs provide descriptive support for the noted limitations. In the absence of descriptive support, the noted limitations are considered to introduce new matter into the claims.
Claims 26 and 27 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
This rejection has been modified from its previous version in order to address applicant’s amendments to the claims.
MPEP § 2163.II.A.3.(b) states, “when filing an amendment an applicant should show support in the original disclosure for new or amended claims”. See also MPEP 714.02. MPEP § 2163.II.A.3.(b) further states, “[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, para. 1, as lacking adequate written description”. According to MPEP § 2163.I.B, “While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure” and “The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117”.
Claims 26 and 27 recite the limitation “a humidity-impermeable aluminum compound foil.” The original application provides descriptive support for an “almost water-/humidity impermeable material. The packaging material for the packaging foil is an aluminum compound foil…” (specification at p. 24, lines 16-17). However, there is no apparent descriptive support for the limitation “a humidity-impermeable aluminum compound foil” in the original application. Consequently, the applicant’s amendment is considered to introduce new matter into the claims.
RESPONSE TO REMARKS: At p. 9 of the instant remarks, applicant argues that paragraphs [0130] and [0160] of the published application (corresponding to the paragraph at p. 20, lines 19-23 and the paragraph at p. 24, lines 15-24 of the substitute specification filed November 15, 2024) provide descriptive support for the noted limitation. However, the cited paragraphs, particularly the disclosure of “almost water-/humidity impermeable,” fail to provide descriptive support for “a humidity-impermeable” as recited in claims 26 and 27. In the absence of descriptive support, the noted limitations are considered to introduce new matter into the claims.
Claim Rejections - 35 USC § 103
Claims 1, 3-10, 13, 14, 22, 24, 26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (CN102031248A; cited on Form PTO-892 mailed August 15, 2024; hereafter “Zhong-1”; reference is made to a machine translation filed August 15, 2024) in view of
Hessler et al. (US 2013/0004784 A1; cited on Form PTO-892 mailed August 15, 2024; hereafter “Hessler”),
Zhong et al. (CN102226174A; cited on Form PTO-892 mailed January 29, 2025; hereafter “Zhong-2”; reference is made to a machine translation filed January 29, 2025),
Spigelman et al. (US 2008/0107699 A1; cited on Form PTO-892 mailed on January 29, 2025; hereafter “Spigelman”),
Fischer et al. (US 2014/0284522 A1; cited on Form PTO-892 mailed on August 15, 2024; hereafter “Fischer”), and
Wang et al. (Int. J. Food Microbiol. 93:209-217, 2004; cited on Form PTO-892 mailed September 26, 2025; hereafter “Wang”).
This rejection has been modified from its previous version in order to address applicant’s amendments to the claims.
As amended, the claims are drawn to a method for making a microorganism loaded multiphase biomaterial comprising nanocellulose, the method comprising:
synthesizing a nanocellulose (BNC) multiphase biomaterial;
resuspending the microorganism in a buffer or a culture medium, and
loading the microorganism into and/or onto the nanocellulose multiphase biomaterial by spraying the microorganism onto the multiphase biomaterial,
wherein the microorganism is at least one selected from the group consisting of Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus fermentum, Bacillus subtilis, and Bacillus megaterium;
incubating the loaded nanocellulose multiphase biomaterial with a moisture binder for drying, wherein the moisture binder is an osmotically and/or hygroscopically effective moisture-binding solution having a concentration of osmotically active and/or hygroscopic substances of 5 to 20%; and
freeze drying the nanocellulose multiphase biomaterial treated with moisture binder for 1-6 days to a residual water content of from 3% to 14%;
to thereby provide the microorganism loaded multiphase biomaterial comprising nanocellulose;
wherein the microorganism component of the microorganism loaded multiphase biomaterial comprising nanocellulose retains viability for at least six months when stored at room temperature,
wherein the viability is measured by an assay comprising culturing the microorganism-loaded multiphase biomaterial in MRS broth medium or TSB medium and measuring optical density at OD600 relative to the McFarland standard.
Regarding instant claims 1 and 28, Zhong-1 teaches a microbial agent comprising a bacterial cellulose and a microorganism (Abstract). Zhong-1 teaches the bacterial cellulose of the agent protects the activity of the microorganism (Abstract). Zhong-1 teaches the microorganism of the agent includes probiotics and lactobacillus (translation, p. 7, paragraph [0019]). Zhong-1 teaches that the bacterial cellulose is made into granules and sterilized before combining with the microorganism in a culture medium and culturing the microorganism in the presence of the bacterial cellulose (translation at paragraph [0015]). Zhong-1 teaches the agent comprising a bacterial cellulose and an applied microorganism is subjected to a drying process (translation at paragraph [0021]).
Differences between Zhong-1 and instant claims 1 and 28 are addressed below.
While Zhong-1 teaches the microbial agent comprises a bacterial cellulose (Abstract), Zhong-1 does not teach the bacterial cellulose is a nanocellulose multiphase biomaterial as recited in claim 1.
Hessler generally teaches a multiphase biomaterial that is based on bacterial nanocellulose (paragraph [0001]), which is suitable for a broad range of applications due to highly versatile determinable structures and material properties (paragraph [0002]) without requiring disadvantageous additives or composite formations produced in the synthesis with them (paragraph [0003]). Hessler teaches a method for synthesizing the multiphase bacterial nanocellulose (beginning at paragraph [0048]).
In view of the combined teachings of Zhong-1 and Hessler, it would have been obvious to one of ordinary skill in the art before the effective filing date to use the multiphase bacterial nanocellulose of Hessler as the bacterial cellulose of the microbial agent of Zhong-1. One would have been motivated and would have expected success to do this because Zhong-1 taught the agent comprises a bacterial cellulose and Hessler taught a bacterial cellulose that is suitable for a broad range of applications with advantageous characteristics including highly versatile determinable structures and material properties.
While Zhong-1 teaches the microorganism includes probiotics and lactobacillus (translation, p. 7, paragraph [0019]) and teaches applying the microorganism to the bacterial cellulose by culturing the microorganism in the presence of the bacterial cellulose (p. 6, paragraph [0015]), Zhong-1 does not teach the microorganism is Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus fermentum, Bacillus subtilis, or Bacillus megaterium and applying the microorganism by spraying as recited in claim 1.
Zhong-2 teaches methods for applying yeast to bacterial cellulose, including spraying a culture liquid of the yeast onto the bacterial cellulose (translation at p. 3, bottom; p. 4, Embodiments two, four, and six).
Spigelman teaches applying probiotic microorganisms to a surface by spraying the surface with the probiotic microorganism (paragraph [0008]). Spigelman teaches exemplary probiotic microorganisms including Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, and Lactobacillus fermentum (paragraph [0017] and Appendix 1 beginning at p. 5).
In view of the combined teachings of Zhong-1, Zhong-2, and Spigelman, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Zhong-1 to apply a probiotic such as Lc. lactis subsp. lactis or Lactobacillus plantarum by spraying a liquid of the probiotic onto a bacterial cellulose. One would have been motivated to do this because Zhong-1 taught applying a probiotic to a bacterial cellulose and Zhong-2 taught spraying as a method for applying a microorganism to a bacterial cellulose. One would have expected success because Zhong-2 taught spraying as a method for applying a microorganism to a bacterial cellulose and Spigelman taught applying probiotic microorganisms including Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, and Lactobacillus fermentum to a surface by spraying.
While Zhong-1 teaches the bacterial cellulose is a freeze-drying protective agent (Abstract), and Zhong teaches the microbial agent is subjected to a freeze-drying process (translation at paragraph [0021]), Zhong-1 does not teach applying a moisture binder for freeze drying as recited in claim 1.
Fischer teaches lyophilization (i.e., freeze-drying) as an established method for bacterial nanocellulose (paragraph [0012]). Fischer teaches that while lyophilization is the method with best results for preserving the structure of bacterial nanocellulose (paragraph [0013]), methods for drying bacterial cellulose alter the structure and reduce the reswellability after drying (paragraphs [0003] to [0025]). Fisher teaches using a moisture binder for drying cellulose without disruptive stress on the cellulose and without loss of stability and efficacy of any additive substances allowing reswelling almost completely to the original structure and consistency (paragraph [0026]). The moisture binder of Fischer is an osmotically and/or hygroscopically effective solution, characterized in that the moisture-binding solution has a concentration of osmotically active and/or hygroscopic substances of 0.01% up to the saturation limit, preferably of 5-20% (claim 4 of Fischer).
In view of the combined teachings of Zhong-1 and Fischer, it would have been obvious to one of ordinary skill in the art to modify Zhong-1 to use the moisture binder of Fischer for freeze drying. One would have been motivated to and would have expected success to do so because Zhong-1 taught freeze drying the microbial agent, while Fischer taught methods for drying bacterial cellulose alter the structure and reduce the reswellability after drying and taught using a moisture binder for drying cellulose, which allows the cellulose to reswell as required almost completely to the original structure and consistency without disruptive stress on the cellulose and without loss of stability and efficacy of any additive substances.
While Zhong-1 teaches selecting appropriate process parameters for freeze-drying according to needs and teaches a freeze-drying time of up to 15 hours (translation at paragraph [0021]), Zhong-1 does not teach freeze drying for 1-6 days or 3-5 days to a residual water content of from 3% to 14% as recited in claims 1 and 28.
Wang teaches water content is an important parameter for the stability of dried cultures and in general, microorganisms survive better at low-water activity (p. 211, column 2). Wang teaches the optimum residual moisture content varies with the composition of the fluid in which the microorganisms are dried, with the storage atmosphere and with the species of organisms (p. 211, column 2, bottom). Wang teaches freeze-drying a probiotic Lactobacillus strain at –50oC and 1.5 mmHg vacuum for about 50 hours (p. 210, column 2), which resulted in a moisture content of 2.9% to 3.5% (p. 212, column 1).
According to MPEP 2144.05.II.A, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." As taught by Wang, freeze-drying time is a parameter of the freeze-drying process to achieve a desired low residual moisture content. In view of the combined teachings of Zhong-1 and Wang, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Zhong-1 to select an optimal and/or workable range of freeze-drying time of 1-6 days or 3-5 days along with other freeze-drying parameters in order to achieve a desired residual moisture content of from 3% to 14%.
While Zhong-1 teaches the microbial agent maintains a high number of live bacteria after long term storage (paragraph [0009]) and after long-term storage, the microorganisms still have strong activity (paragraph [0024]), Zhong-1 does not teach the microorganism component of the microbial agent retains viability for at least six months when stored at room temperature, wherein the viability is measured by an assay comprising culturing the microorganism-loaded multiphase biomaterial in MRS broth medium or TSB medium and measuring optical density at OD600 relative to the McFarland standard as recited in claim 1.
Wang teaches that following a freeze-drying process for fermented soymilk comprising lactic acid bacteria, the product was stored in a laminated pouch comprising nylon/aluminum/retort coated polypropylene, which was vacuum sealed before storage (p. 210, column 2, bottom). Wang teaches 38% survival of S. thermophilus and 61% survival of B. longum in the freeze-dried product after storage in the laminated pouch for 4 months at room temperature (p. 214, Table 5).
Given the teachings of Wang, one of ordinary skill in the art would have reasonably expected that the microbial agent made according to the combination of Zhong-1, Hessler, Othman, Spigelman, Fischer, and Wang would have retained viability for at least six months when stored at room temperature, wherein the viability is measured by an assay comprising culturing in MRS broth medium or TSB medium and measuring optical density at OD600 relative to the McFarland standard.
Moreover, according to MPEP 2112.01.I, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Since the combination of cited prior art teaches and/or suggests all active steps of claim 1 that must be performed to make the microorganism loaded multiphase biomaterial comprising nanocellulose, it is presumed that the microbial agent made according to the combination of Zhong-1, Hessler, Othman, Spigelman, Fischer, and Wang would have retained viability for at least six months when stored at room temperature, wherein the viability is measured by an assay comprising culturing in MRS broth medium or TSB medium and measuring optical density at OD600 relative to the McFarland standard.
In the interest of clarity, it is noted that the recitation of “wherein the viability is measured by an assay comprising culturing in MRS broth medium or TSB medium and measuring optical density at OD600 relative to the McFarland standard” is interpreted as setting forth the method for measuring viability but does not require any active steps of measuring by an assay comprising culturing in MRS broth medium or TSB medium and measuring optical density at OD600 relative to the McFarland standard in order to practice the claimed method.
Regarding instant claim 3, Spigelman teaches that generally, probiotic microorganisms may be viable or may be in the form of a spore (paragraph [0027]).
Regarding instant claim 4, modifying Zhong-1 to apply a probiotic such as Lc. lactis subsp. lactis or Lactobacillus plantarum by spraying a liquid of the probiotic onto a bacterial cellulose would use a “wet” microorganism.
Regarding instant claim 5, by modifying Zhong-1 to apply a probiotic such as Lc. lactis subsp. lactis or Lactobacillus plantarum to spray a liquid of the probiotic onto a bacterial cellulose would result in a “wet” bacterial cellulose.
Regarding instant claim 6, the bacterial cellulose of Hessler is derived from bacteria.
Regarding instant claim 7, Hessler teaches the bacterial cellulose comprises layered phases (paragraphs [0022] and [0023]).
Regarding instant claims 8 and 22, Hessler teaches the thickness of the individual phases and the resulting properties can be controlled by shifting the inoculation ratio to produce the BNC (paragraph [0046]), and Zhong-1 teaches that the bacterial cellulose particles preferably have a side length of 3 to 8 mm (translation at p. 7, paragraph [0018]).
Regarding instant claim 9, Hessler teaches a plurality of bacterial cellular networks that form a homogenous phase system (paragraph [0023]).
Regarding instant claim 10, Hessler summarizes methods for modifying homogeneous or multi-phase biomaterials based on BNC (beginning at paragraph [0004]) teaching that carboxymethyl cellulose (CMC) and methyl cellulose (MC) affect the pore size of the BNC network (paragraph [0007]).
Regarding instant claim 13, Spigelman teaches the probiotic bacteria include Lactobacillus lactis (subsp. Lactis (paragraph [0017]).
Regarding instant claim 14, Spigelman teaches that viability of probiotics may be facilitated by incorporation of nutrients such as amino acids (paragraph [0027]).
Regarding instant claim 24, Fischer teaches glucose or magnesium chloride as the moisture binder (paragraph [0054] and Figure 3).
Regarding instant claim 26, Wang teaches that following a freeze-drying process for fermented soymilk comprising lactic acid bacteria, the product was stored in a laminated pouch comprising nylon/aluminum/retort coated polypropylene, which was vacuum sealed before storage (p. 210, column 2, bottom). Wang teaches the moisture content of the freeze-dried product had an initial moisture content of 3.09% and after storage in the laminated pouch at 4oC or 25oC for four months had a moisture content of 3.09% and 3.10%, respectively (p. 214, Table 5). Wang teaches storage in the laminated pouch increases survivability relative to storage in a glass or PET bottle (p. 215, Figure 2; p. 216, column 1). The vacuum-sealed laminated pouch of Wang is considered to be encompassed by “a humidity-impermeable aluminum composite foil.”
Therefore, the invention of claims 1, 3-10, 13, 14, 22, 24, 26, and 28 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claims 19, 23, 25, 27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong-1 in view of Hessler, Othman et al. (AMB Expr. 7:215, 2017, 14 pages; cited on Form PTO-892 filed September 26, 2025; hereafter “Othman”), Spigelman, Fischer, and Wang.
This rejection has been modified from its previous version in order to address applicant’s amendments to the claims.
As amended, claim 19 is drawn to a method for making a microorganism loaded multiphase biomaterial comprising nanocellulose, the method comprising:
synthesizing a nanocellulose (BNC) multiphase biomaterial;
resuspending the microorganism in a buffer or a culture medium, and
loading the microorganism into and/or onto the nanocellulose multiphase biomaterial by (1) mixing the nanocellulose multiphase biomaterial with the microorganisms at 300 rpm or more at a temperature of 37° C or less, (2) injecting the microorganisms into the nanocellulose multiphase biomaterial and incubating at a temperature of 37° C or less, or (3) incubating the nanocellulose multiphase biomaterial in the buffer or culture medium with resuspended microorganisms at a temperature of 37° C or less for 60 min or less,
wherein the microorganism is at least one selected from the group consisting of Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus fermentum, Bacillus subtilis, and Bacillus megaterium;
incubating the loaded nanocellulose multiphase biomaterial with a moisture binder for drying, wherein the moisture binder is an osmotically and/or hygroscopically effective moisture-binding solution having a concentration of osmotically active and/or hygroscopic substances of 5 to 20%; and
freeze drying the nanocellulose multiphase biomaterial treated with moisture binder for 1-6 days to a residual water content of from 3% to 14%;
to thereby provide the microorganism loaded multiphase biomaterial comprising nanocellulose;
wherein the microorganism component of the microorganism loaded multiphase biomaterial comprising nanocellulose retains viability for at least six months when stored at room temperature,
wherein the viability is measured by an assay comprising culturing the microorganism-loaded multiphase biomaterial in MRS broth medium or isotonic saline NaCl 0.9% and measuring optical density at OD600 relative to the McFarland standard.
Regarding instant claims 19 and 29, Zhong-1 teaches a microbial agent comprising a bacterial cellulose and a microorganism (Abstract). Zhong-1 teaches the bacterial cellulose of the agent protects the activity of the microorganism (Abstract). Zhong-1 teaches the microorganism of the agent includes probiotics and lactobacillus (translation, p. 7, paragraph [0019]). Zhong-1 teaches that the bacterial cellulose is made into granules and sterilized before combining with the microorganism in a culture medium and culturing the microorganism in the presence of the bacterial cellulose (translation at paragraph [0015]). Zhong-1 teaches the agent comprising a bacterial cellulose and an applied microorganism is subjected to a drying process (translation at paragraph [0021]).
Differences between Zhong-1 and claims 19 and 29 are addressed below.
While Zhong-1 teaches the microbial agent comprises a bacterial cellulose (Abstract), Zhong-1 does not teach the bacterial cellulose is a nanocellulose multiphase biomaterial as recited in claim 19.
Hessler generally teaches a multiphase biomaterial that is based on bacterial nanocellulose (paragraph [0001]), which is suitable for a broad range of applications due to highly versatile determinable structures and material properties (paragraph [0002]) without requiring disadvantageous additives or composite formations produced in the synthesis with them (paragraph [0003]). Hessler teaches a method for synthesizing the multiphase bacterial nanocellulose (beginning at paragraph [0048]).
In view of the combined teachings of Zhong-1 and Hessler, it would have been obvious to one of ordinary skill in the art before the effective filing date to use the multiphase bacterial nanocellulose of Hessler as the bacterial cellulose of the microbial agent of Zhong-1. One would have been motivated to and would have had a reasonable expectation of success to do this because Zhong-1 taught the agent comprises a bacterial cellulose and Hessler taught a bacterial cellulose that is suitable for a broad range of applications with advantageous characteristics including highly versatile determinable structures and material properties.
While Zhong-1 teaches the microorganism includes probiotics and lactobacillus (translation at paragraph [0019]) and teaches applying the microorganism to the bacterial cellulose by culturing a microorganism in the presence of the bacterial cellulose at 37° C (translation at paragraphs [0015], [0031], [0032], [0040], [0041], [0050], and [0051]), Zhong-1 does not teach applying the microorganism by mixing the nanocellulose multiphase biomaterial with the microorganisms at 300 rpm, and does not teach the microorganism is Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus fermentum, Bacillus subtilis, or Bacillus megaterium as recited in claim 19.
Othman teaches an evaluation of agitation speed on growth of a probiotic lactic acid bacterium, noting that increasing agitation speed from 200 to 300 rpm improved viable cell concentration, viable cell yield, viable cell productivity, lactic acid production, lactic acid yield and lactic acid productivity (paragraph bridging pp. 6-7). Othman teaches these results are in agreement with a previous observation of improved growth of Lactobacillus plantarum in the presence of oxygen compared to anaerobic condition (p. 11, column 2, middle).
Spigelman teaches exemplary probiotic microorganisms including Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, and Lactobacillus fermentum (paragraph [0017] and Appendix 1 beginning at p. 5).
In view of the combined teachings of Zhong-1, Othman, and Spigelman, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Zhong-1 to use an agitation speed of 300 rpm to apply a probiotic such as Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, or Lactobacillus fermentum to a nanocellulose multiphase biomaterial. One would have been motivated to and would have expected success to do this because, while Zhong-1 teaches applying a microorganism to bacterial cellulose by culturing a microorganism in the presence of the bacterial cellulose at 37° C, Zhong-1 does not teach an agitation speed for the culturing and Othman teaches an agitation speed of 300 rpm for improved viable cell concentration, viable cell yield, viable cell productivity, lactic acid production, lactic acid yield and lactic acid productivity, and Spigelman teaches exemplary probiotic microorganisms including Lactococcus lactis, Lactobacillus rhamnosus, and Lactobacillus plantarum, and Lactobacillus fermentum.
While Zhong-1 teaches the bacterial cellulose is a freeze-drying protective agent (Abstract), and Zhong teaches the microbial agent is subjected to a freeze-drying process (translation at paragraph [0021]), Zhong-1 does not teach applying a moisture binder for freeze drying as recited in claim 19.
Fischer teaches lyophilization (i.e., freeze-drying) as an established method for bacterial nanocellulose (paragraph [0012]). Fischer teaches that while lyophilization is the method with best results for preserving the structure of bacterial nanocellulose (paragraph [0013]), methods for drying bacterial cellulose alter the structure and reduce the reswellability after drying (paragraphs [0003] to [0025]). Fisher teaches uses a moisture binder for drying cellulose without disruptive stress on the cellulose and without loss of stability and efficacy of any additive substances allowing reswelling almost completely to the original structure and consistency (paragraph [0026]). The moisture binder of Fischer is an osmotically and/or hygroscopically effective solution, characterized in that the moisture-binding solution has a concentration of osmotically active and/or hygroscopic substances of 0.01% up to the saturation limit, preferably of 5-20% (claim 4 of Fischer).
In view of the combined teachings of Zhong-1 and Fischer, it would have been obvious to one of ordinary skill in the art to further modify Zhong-1 to use the moisture binder of Fischer for freeze drying. One would have been motivated to and would have had a reasonable expectation of success to do so because Zhong-1 taught freeze drying the microbial agent, while Fischer taught methods for drying bacterial cellulose alter the structure and reduce the reswellability after drying and taught using a moisture binder for drying cellulose, which allows the cellulose to reswell as required almost completely to the original structure and consistency without disruptive stress on the cellulose and without loss of stability and efficacy of any additive substances.
While Zhong-1 teaches selecting appropriate process parameters for freeze-drying according to needs and teaches a freeze-drying time of up to 15 hours (translation at paragraph [0021]), Zhong-1 does not teach freeze drying for 1-6 days or 3-5 days to a residual water content of from 3% to 14% as recited in claims 19 and 29.
Wang teaches water content is an important parameter for the stability of dried cultures and in general, microorganisms survive better at low-water activity (p. 211, column 2). Wang teaches freeze-drying a probiotic Lactobacillus strain at –50oC and 1.5 mmHg vacuum for about 50 hours (p. 210, column 2), which resulted in a moisture content of 2.9% to 3.5% (p. 212, column 1).
According to MPEP 2144.05.II.A, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." As taught by Wang, freeze-drying time is a parameter of the freeze-drying process to achieve a desired low residual moisture content. In view of the combined teachings of Zhong-1 and Wang, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify Zhong-1 to select an optimal and/or workable range of freeze-drying time of 1-6 days or 3-5 days along with other freeze-drying parameters in order to achieve a desired residual moisture content of from 3% to 14%.
While Zhong-1 teaches the microbial agent maintains a high number of live bacteria after long term storage (paragraph [0009]) and after long-term storage, the microorganisms still have strong activity (paragraph [0024]), Zhong-1 does not teach the microorganism component of the microbial agent retains viability for at least six months when stored at room temperature, wherein the viability is measured by an assay comprising culturing in MRS broth medium or isotonic saline NaCl 0.9% and measuring optical density at OD600 relative to the McFarland standard as recited in claim 19.
Wang teaches that following a freeze-drying process for fermented soymilk comprising lactic acid bacteria, the product was stored in a laminated pouch comprising nylon/aluminum/retort coated polypropylene, which was vacuum sealed before storage (p. 210, column 2, bottom). Wang teaches 38% survival of S. thermophilus and 61% survival of B. longum in the freeze-dried product after storage in the laminated pouch for 4 months at room temperature (p. 214, Table 5).
Given the teachings of Wang, one of ordinary skill in the art would have reasonably expected that the microbial agent made according to the combination of Zhong-1, Hessler, Othman, Spigelman, Fischer, and Wang would retain viability for at least six months when stored at room temperature, wherein the viability is measured by an assay comprising culturing in MRS broth medium or isotonic saline NaCl 0.9% and measuring optical density at OD600 relative to the McFarland standard.
Moreover, according to MPEP 2112.01.I, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Since the combination of cited prior art teaches and/or suggests all active steps of claim 1 that must be performed to make the microorganism loaded multiphase biomaterial comprising nanocellulose, it is presumed that the microbial agent made according to the combination of Zhong-1, Hessler, Othman, Spigelman, Fischer, and Wang would retain viability for at least six months when stored at room temperature, wherein the viability is measured by an assay comprising culturing in MRS broth medium or isotonic saline NaCl 0.9% and measuring optical density at OD600 relative to the McFarland standard.
In the interest of clarity, it is noted that the recitation of “wherein the viability is measured by an assay comprising culturing the microorganism-loaded multiphase biomaterial in MRS broth medium or isotonic saline NaCl 0.9% and measuring optical density at OD600 relative to the McFarland standard” is interpreted as setting forth the method for measuring viability but does not require active steps of measuring by an assay comprising culturing in MRS broth medium or isotonic saline NaCl 0.9% and measuring optical density at OD600 relative to the McFarland standard in order to practice the claimed method.
Regarding instant claim 23, Hessler teaches the thickness of the individual phases and the resulting properties can be controlled by shifting the inoculation ratio to produce the BNC (paragraph [0046]), and Zhong-1 teaches that the bacterial cellulose particles preferably have a side length of 3 to 8 mm (translation at p. 7, paragraph [0018]).
Regarding instant claim 25, Fischer teaches glucose or magnesium chloride as the moisture binder (paragraph [0054] and Figure 3).
Regarding instant claim 27, Wang teaches that following a freeze-drying process for fermented soymilk comprising lactic acid bacteria, the product was stored in a laminated pouch comprising nylon/aluminum/retort coated polypropylene, which was vacuum sealed before storage (p. 210, column 2, bottom). Wang teaches the moisture content of the freeze-dried product had an initial moisture content of 3.09% and after storage in the laminated pouch at 4oC or 25oC for four months had a moisture content of 3.09% and 3.10%, respectively (p. 214, Table 5). Wang teaches storage in the laminated pouch increases survivability relative to storage in a glass or PET bottle (p. 215, Figure 2; p. 216, column 1). The vacuum-sealed laminated pouch of Wang is considered to be encompassed by “a humidity-impermeable aluminum composite foil.”
Therefore, the invention of claims 19, 23, 25, 27, and 29 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claims 19, 23, 25, 27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong-1 in view of Hessler, Zhong-2, Spigelman, Fischer, and Wang.
This rejection has been modified from its previous version in order to address applicant’s amendments to the claims.
Regarding instant claims 19 and 29, Zhong-1 teaches a microbial agent comprising a bacterial cellulose and a microorganism (Abstract). Zhong-1 teaches the bacterial cellulose of the agent protects the activity of the microorganism (Abstract). Zhong-1 teaches the microorganism of the agent includes probiotics and lactobacillus (translation, p. 7, paragraph [0019]). Zhong-1 teaches that the bacterial cellulose is made into granules and sterilized before combining with the microorganism in a culture medium and culturing the microorganism in the presence of the bacterial cellulose (translation at paragraph [0015]). Zhong-1 teaches the agent comprising a bacterial cellulose and an applied microorganism is subjected to a drying process (translation at paragraph [0021]).
Differences between Zhong-1 and claims 19 and 29 are addressed below.
While Zhong-1 teaches the microbial agent comprises a bacterial cellulose (Abstract), Zhong-1 does not teach the bacterial cellulose is a nanocellulose multiphase biomaterial as recited in claim 19.
Hessler generally teaches a multiphase biomaterial that is based on bacterial nanocellulose (paragraph [0001]), which is suitable for a broad range of applications due to highly versatile determinable structures and material properties (paragraph [0002]) without requiring disadvantageous additives or composite formations produced in the synthesis with them (paragraph [0003]). Hessler teaches a method for synthesizing the multiphase bacterial nanocellulose (beginning at paragraph [0048]).
In view of the combined teachings of Zhong-1 and Hessler, it would have been obvious to one of ordinary skill in the art before the effective filing date to use the multiphase bacterial nanocellulose of Hessler as the bacterial cellulose of the microbial agent of Zhong-1. One would have been motivated to and would have had a reasonable expectation of success to do this because Zhong-1 taught the agent comprises a bacterial cellulose and Hessler taught a bacterial cellulose that is suitable for a broad range of applications with advantageous characteristics including highly versatile determinable structures and material properties.
While Zhong-1 teaches the microorganism includes probiotics and lactobacillus (translation at paragraph [0019]) and teaches applying the microorganism to the bacterial cellulose by culturing a microorganism in the presence of the bacterial cellulose at 37° C for a time of 5, 10, or 12 hours (translation at paragraphs [0015], [0031], [0032], [0040], [0041], [0050], and [0051]), Zhong-1 does not teach applying the microorganism by incubating the nanocellulose multiphase biomaterial in culture medium with resuspended microorganisms for less for 60 min or less, and does not teach the microorganism is Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus fermentum, Bacillus subtilis, or Bacillus megaterium as recited in claim 19.
Zhong-2 teaches methods for applying yeast to bacterial cellulose, including culturing a microorganism (yeast) with bacterial cellulose at room temperature for 2 or 4 hours (translation at p. 4, Embodiments one and five).
Spigelman teaches exemplary probiotic microorganisms including Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, and Lactobacillus fermentum (paragraph [0017] and Appendix 1 beginning at p. 5).
In view of the combined teachings of Zhong-1, Zhong-2, and Spigelman, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Zhong-1 to apply a probiotic such as Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, or Lactobacillus fermentum by incubating the nanocellulose multiphase biomaterial in culture medium with resuspended microorganisms at a temperature of 37° C or less for 60 min or less. According to MPEP 2144.05.II.A, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." Given that Zhong-1 and Zhong-2 each teaches various temperatures and times for applying a microorganism to a bacterial cellulose and Spigelman teaches exemplary probiotic microorganisms, it would have been obvious to one of ordinary skill in the art at the time of the invention to select parameters for incubating a multiphase bacterial nanocellulose with a probiotic such as Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, or Lactobacillus fermentum to achieve an optimal and/or workable range of temperatures and times.
While Zhong-1 teaches the bacterial cellulose is a freeze-drying protective agent (Abstract), and Zhong teaches the microbial agent is subjected to a freeze-drying process (translation at paragraph [0021]), Zhong-1 does not teach applying a moisture binder for freeze drying as recited in claim 19.
Fischer teaches lyophilization (i.e., freeze-drying) as an established method for bacterial nanocellulose (paragraph [0012]). Fischer teaches that while lyophilization is the method with best results for preserving the structure of bacterial nanocellulose (paragraph [0013]), methods for drying bacterial cellulose alter the structure and reduce the reswellability after drying (paragraphs [0003] to [0025]). Fisher teaches uses a moisture binder for drying cellulose without disruptive stress on the cellulose and without loss of stability and efficacy of any additive substances allowing reswelling almost completely to the original structure and consistency (paragraph [0026]). The moisture binder of Fischer is an osmotically and/or hygroscopically effective solution, characterized in that the moisture-binding solution has a concentration of osmotically active and/or hygroscopic substances of 0.01% up to the saturation limit, preferably of 5-20% (claim 4 of Fischer).
In view of the combined teachings of Zhong-1 and Fischer, it would have been obvious to one of ordinary skill in the art to further modify Zhong-1 to use the moisture binder of Fischer for freeze drying. One would have been motivated to and would have had a reasonable expectation of success to do so because Zhong-1 taught freeze drying the microbial agent, while Fischer taught methods for drying bacterial cellulose alter the structure and reduce the reswellability after drying and taught using a moisture binder for drying cellulose, which allows the cellulose to reswell as required almost completely to the original structure and consistency without disruptive stress on the cellulose and without loss of stability and efficacy of any additive substances.
While Zhong-1 teaches selecting appropriate process parameters for freeze-drying according to needs and teaches a freeze-drying time of up to 15 hours (translation at paragraph [0021]), Zhong-1 does not teach freeze drying for 1-6 days or 3-5 days to a residual water content of from 3% to 14% as recited in claims 19 and 29.
Wang teaches water content is an important parameter for the stability of dried cultures and in general, microorganisms survive better at low-water activity (p. 211, column 2). Wang teaches freeze-drying a probiotic Lactobacillus strain at –50oC and 1.5 mmHg vacuum for about 50 hours (p. 210, column 2), which resulted in a moisture content of 2.9% to 3.5% (p. 212, column 1).
In view of the combined teachings of Zhong-1 and Wang, it would have been obvious to one of ordinary skill in the art to further modify Zhong-1 to select freeze drying parameters of 1-6 days to a residual water content of from 3% to 14%. According to MPEP 2144.05.II.A, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." Given that Zhong-1 teaches selecting appropriate process parameters for freeze-drying according to needs, Wang teaches water content is an important parameter for the stability of dried cultures and in general, microorganisms survive better at low-water activity, and teaches freeze-drying a probiotic Lactobacillus strain for about 50 hours, which resulted in a moisture content of 2.9% to 3.5%, it would have been obvious to one of ordinary skill in the art at the time of the invention to select freeze drying parameters that achieve an optimal and/or workable range of freeze drying time and residual water content.
While Zhong-1 teaches the microbial agent maintains a high number of live bacteria after long term storage (paragraph [0009]) and after long-term storage, the microorganisms still have strong activity (paragraph [0024]), Zhong-1 does not teach the microorganism component of the microbial agent retains viability for at least six months when stored at room temperature, wherein the viability is measured by an assay comprising culturing in MRS broth medium or isotonic saline NaCl 0.9% and measuring optical density at OD600 relative to the McFarland standard as recited in claim 19.
Wang teaches that following a freeze-drying process for fermented soymilk comprising lactic acid bacteria, the product was stored in a laminated pouch comprising nylon/aluminum/retort coated polypropylene, which was vacuum sealed before storage (p. 210, column 2, bottom). Wang teaches 38% survival of S. thermophilus and 61% survival of B. longum in the freeze-dried product after storage in the laminated pouch for 4 months at room temperature (p. 214, Table 5).
Given the teachings of Wang, one of ordinary skill in the art would have reasonably expected that the microbial agent made according to the combination of Zhong-1, Hessler, Othman, Spigelman, Fischer, and Wang would have retained viability for at least six months when stored at room temperature, wherein the viability is measured by an assay comprising culturing in MRS broth medium or isotonic saline NaCl 0.9% and measuring optical density at OD600 relative to the McFarland standard.
Moreover, according to MPEP 2112.01.I, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Since the combination of cited prior art teaches and/or suggests all active steps of claim 1 that must be performed to make the microorganism loaded multiphase biomaterial comprising nanocellulose, it is presumed that the microbial agent made according to the combination of Zhong-1, Hessler, Othman, Spigelman, Fischer, and Wang would have retained viability for at least six months when stored at room temperature, wherein the viability is measured by an assay comprising culturing in MRS broth medium or isotonic saline NaCl 0.9% and measuring optical density at OD600 relative to the McFarland standard.
In the interest of clarity, it is noted that the recitation of “wherein the viability is measured by an assay comprising culturing the microorganism-loaded multiphase biomaterial in MRS broth medium or isotonic saline NaCl 0.9% and measuring optical density at OD600 relative to the McFarland standard” is interpreted as setting forth the method for measuring viability but does not require active steps of measuring by an assay comprising culturing in MRS broth medium or isotonic saline NaCl 0.9% and measuring optical density at OD600 relative to the McFarland standard in order to practice the claimed method.
Regarding instant claim 23, Hessler teaches the thickness of the individual phases and the resulting properties can be controlled by shifting the inoculation ratio to produce the BNC (paragraph [0046]), and Zhong-1 teaches that the bacterial cellulose particles preferably have a side length of 3 to 8 mm (translation at p. 7, paragraph [0018]).
Regarding instant claim 25, Fischer teaches glucose or magnesium chloride as the moisture binder (paragraph [0054] and Figure 3).
Regarding instant claim 27, Wang teaches that following a freeze-drying process for fermented soymilk comprising lactic acid bacteria, the product was stored in a laminated pouch comprising nylon/aluminum/retort coated polypropylene, which was vacuum sealed before storage (p. 210, column 2, bottom). Wang teaches the moisture content of the freeze-dried product had an initial moisture content of 3.09% and after storage in the laminated pouch at 4oC or 25oC for four months had a moisture content of 3.09% and 3.10%, respectively (p. 214, Table 5). Wang teaches storage in the laminated pouch increases survivability relative to storage in a glass or PET bottle (p. 215, Figure 2; p. 216, column 1). The vacuum-sealed laminated pouch of Wang is considered to be encompassed by “a humidity-impermeable aluminum composite foil.”
Therefore, the invention of claims 19, 23, 25, 27, and 29 would have been obvious to one of ordinary skill in the art before the effective filing date.
RESPONSE TO REMARKS: Beginning at p. 9 of the instant remarks, applicant argues Zhong-1 is incompatible with Zhong-2 and Spigelman because Zhong-1 teaches applying the microorganism to the bacterial cellulose by culturing the microorganism in the presence of the bacterial cellulose while Zhong-2 and Spigelman teach applying yeast or probiotic bacteria by spraying. Applicant contends that one of ordinary skill would understand that replacing the co-cultivation of Zhong-1 with spraying would destroy the mechanism Zhong-1 relies upon for loading and thus, according to applicant, there is no technical motivation to bodily combine these references.
Applicant’s arguments are not found persuasive. There is no evidence of record that Zhong-1 criticizes, discredits, or discourages methods of applying probiotic microorganisms to bacterial cellulose other than contacting the microorganism to the bacterial cellulose in culture. Zhong-2 acknowledges applying a microorganism to bacterial cellulose by contacting the microorganism to the bacterial cellulose in culture (similar to Zhong-1) and presents the alternative of spraying the microorganism onto bacterial cellulose (translation at p. 3, bottom and claim 6). Spigelman taught applying microorganisms including probiotic Lc. lactis subsp. lactis or Lactobacillus plantarum to a surface by spraying the surface with the probiotic microorganisms. In view of the combined teachings of Zhong-1, Zhong-2, and Spigelman, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Zhong-1 to apply a probiotic such as Lc. lactis subsp. lactis or Lactobacillus plantarum by spraying a liquid of the probiotic microorganisms onto a bacterial cellulose.
At p. 10 of the instant remarks, applicant argues Zhong-2 is directed to immobilizing yeast onto bacterial cellulose for ethanol and beer fermentation. Applicant contends that yeast cells are so different from probiotic bacteria that one of ordinary skill would not assume that a spraying method developed to immobilize yeast cells would successfully load and preserve fragile, living probiotic bacteria without killing them.
Applicant’s arguments are not found persuasive. First, according to MPEP 716.01(c).II, arguments by applicant cannot take the place of evidence and there is no evidence of record to support applicant’s allegation that probiotic bacteria are highly sensitive to shear stress, desiccation, and osmotic changes and one of ordinary skill would not assume that a spraying method developed to immobilize yeast cells would successfully load and preserve fragile, living probiotic bacteria without killing them.
Second, it appears applicant is requiring absolute predictability of success of the claimed invention. However, according to MPEP 2143.02.II, obviousness does not require absolute predictability of success, only some degree of predictability is required. Given that Spigelman taught applying microorganisms including probiotic Lc. lactis subsp. lactis or Lactobacillus plantarum to a surface by spraying the surface with the probiotic microorganisms, one would have had at least some degree of predictability to modify the method of Zhong-1 to apply a probiotic such as Lc. lactis subsp. lactis or Lactobacillus plantarum by spraying a liquid of the probiotic onto a bacterial cellulose.
At p. 10 of the instant remarks, applicant argues Fischer is concerned with polymer drying and does not teach loading viable microorganisms. Applicant contends that exposing living, non-spore-forming vegetative bacteria to a highly osmotic 5-20% salt or sugar solution such as taught by Fischer would normally be avoided by a microbiologist because it causes severe osmotic shock and cell death prior to drying. Applicant argues that Fischer is not concerned with maintaining bacterial viability and provides absolutely no teaching that its cellulose preservation technique would preserve microbial life.
Applicant’s arguments are not found persuasive. According to MPEP 716.01(c).II, arguments by applicant cannot take the place of evidence and there is no evidence of record to support applicant’s allegation that modifying Zhong-1 to use the moisture binder of Fischer for freeze drying would cause severe osmotic shock and cell death prior to drying. Rather, the prior art as exemplified by Prasad et al. (Applied and Environmental Microbiology 69:917-925, 2003; cited on the attached Form PTO-892) teaches that previous investigations carried out on bacteria have demonstrated that they possess an inherent ability to adapt to unfavorable environments by the induction of various general and specific stress responses (p. 917, column 1, bottom), acknowledges the robustness of probiotic Lactobacillus plantarum to stress adaption (p. 924, column 2, middle), and teaches that probiotic Lactobacillus plantarum exhibits osmotic protection by stress adaption (p. 924, column 2, middle). As such, one would have had at least some degree of predictability to modify the method of Zhong-1 to use the moisture binder of Fischer for freeze drying.
At p. 11 of the instant remarks, applicant argues the rejection cannot rely on Wang to establish inherency of the claim limitation “wherein the microorganism component of the microorganism loaded multiphase biomaterial comprising nanocellulose retains viability for at least six months when stored at room temperature.”
Applicant’s argument is not found persuasive. Contrary to applicant’s position, the rejection does not rely on Wang to establish inherency. Rather, the teachings of Wang as directed to the limitation “wherein the microorganism component of the microorganism loaded multiphase biomaterial comprising nanocellulose retains viability for at least six months when stored at room temperature” are cited to show that one of ordinary skill in the art would have reasonably expected that the microbial agent made according to the combination of Zhong-1, Hessler, Othman, Spigelman, Fischer, and Wang would have retained viability for at least six months when stored at room temperature. The inherency rationale directed to the limitation of “wherein the microorganism component of the microorganism loaded multiphase biomaterial comprising nanocellulose retains viability for at least six months when stored at room temperature” is an alternative to and does not rely on the teachings of Wang.
At p. 11 of the instant remarks, applicant argues Othman is technically misplaced because Othman is not related to loading a pre-synthesized BNC carrier. Applicant contends that one of ordinary skill would have had no reason to apply the teachings of Othman to loading a pre-synthesized BNC carrier because mixing the nanocellulose multiphase biomaterial with the microorganisms at 300 rpm or more would have been expected to damage the BNC network or shear the delicate bacterial cells.
Applicant’s arguments are not found persuasive. First, according to MPEP 716.01(c).II, arguments by applicant cannot take the place of evidence and there is no evidence of record to support applicant’s allegation that mixing the nanocellulose multiphase biomaterial with the microorganisms at 300 rpm or more would have been expected to damage the BNC network or shear the delicate bacterial cells.
Second, Othman provides motivation and reasonable expectation of success to modify the method of Zhong-1 to use an agitation speed of 300 rpm to apply a probiotic such as Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, or Lactobacillus fermentum to a nanocellulose multiphase biomaterial. Zhong-1 is silent regarding the culture conditions for adding the probiotic bacteria to the bacterial cellulose while Othman advises using increased agitation speed from 200 rpm to 300 rpm, which improved viable cell concentration, viable cell yield, viable cell productivity, lactic acid production, lactic acid yield and lactic acid productivity, consistent with a previous observation of improved growth of Lactobacillus plantarum in the presence of oxygen compared to anaerobic condition. Contrary to applicant’s position, in view of the combined teachings of Zhong-1 and Othman, one would have been motivated and would have expected success to modify the method of Zhong-1 to use an agitation speed of 300 rpm to apply a probiotic such as Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, or Lactobacillus fermentum to a nanocellulose multiphase biomaterial.
At p. 12 of the instant remarks, applicant argues the successful loading of BNC under the recited parameters while maintaining 6-month room-temperature viability represents a technical synergy that could not have been predicted as successful based on the state of the art.
Applicant’s arguments are not found persuasive. Contrary to applicant’s position, given the teachings of Wang, one of ordinary skill in the art would have reasonably expected that the microbial agent made according to the combination of cited prior art would have retained viability for at least six months when stored at room temperature, or, in the alternative, since the combination of cited prior art teaches and/or suggests all active steps of the claims that must be performed to make the microorganism loaded multiphase biomaterial comprising nanocellulose, it is presumed that the microbial agent made according to the combination of cited prior art would have retained viability for at least six months when stored at room temperature.
At p. 12 of the instant remarks, applicant argues the assertions and conclusion in the rejections imply that the claim features would have been simple to achieve or otherwise somehow easily met after the fact and rely on impermissible hindsight reasoning.
Applicant's arguments are not found persuasive. In response to applicant's arguments that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See MPEP 2145.X.A. In this case, the rejections rely only on knowledge which was within the level of ordinary skill at the time the claimed invention was made, and do not include knowledge gleaned only from the applicant's disclosure. Thus, contrary to applicant's position, the rejections do not rely on an improper hindsight analysis.
For these reasons, it is the examiner’s position that the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date.
Claim Rejections - Double Patenting
The provisional rejection of claims 1, 3-6, 8, 13, 14, 19, and 22-29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11, and 12 of copending Application No. 17/625,955 (reference application) in view of Fischer and Wang, and
the provisional rejection of claims 7, 9, and 10 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11, and 12 of copending Application No. 17/625,955 in view of Fischer and Wang as applied to claims 1, 3-6, 8, 13, 14, 19, and 22-29 above, and further in view of Hessler
are withdrawn in view of applicant’s submission of a terminal disclaimer disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Number 17/625,955.
Conclusion
Status of the claims:
Claims 1, 3-10, 13, 14, 19, and 22-29 are pending.
Claims 1, 3-10, 13, 14, 19, and 22-29 are rejected.
No claim is in condition for allowance.
THIS ACTION IS MADE FINAL. 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.
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/David Steadman/Primary Examiner, Art Unit 1656
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