Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
1. Claims 11, 35-36, and 39 are pending and subject to examination on the merits. Claim 39 is withdrawn from consideration as being drawn to non-elected subject matter. Claims 11 and 35-36 are currently under examination.
Priority
2. Acknowledgement is made of applicant’s claim for foreign priority based on an application filed in Brazil BR102019009242-4 on 06 May 2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Withdrawn Objections/Rejections
3. The objection to claim 11 is withdrawn, since the claim was amended to recite “Gluconacetobacter.”
4. The 35 U.S.C. 112(b) indefinite rejection of claims 11 and 35-36 for not listing the bacteria as a component of the fermenting step is withdrawn, since claim 11 was amended to recite “Gluconacetobacter sp. in,” which made clearer that the microorganism is part of the fermentation method.
Maintained Rejections
Claim Rejections - 35 USC § 103
5. 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.
6. 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.
7. Claims 11 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (Park et al., 2012, KR101435582B1-cited previously), Zhang et al. (Zhang et al., 2010, CN101302486B—cited previously), and Agarwal et al. (Agarwal et al., 2015, Part Part Syst Charact—cited previously), and Choe et al. (Choe et al., 2010, Journal of Reproduction and Development—cited previously).
In regards to claim 11, drawn to a method to manufacture 3D bacterial nanocellulose by Gluconacetobacter sp., by modulating the composition of a culture medium as to carbon, nitrogen, and micronutrient source, where the modulating step involves a fermentation step in culture medium with more than one non-complex nitrogen source for 3-10 days at 25oC-30oC, wherein said non-complex nitrogen source is one selected from: a) ammonium chloride and ammonium glutamate; and b) ammonium sulfate and ammonium nitrate, causing adsorption or absorption of biologically active molecules including β-mercaptoethanol in the microstructure of said matrix; and incorporating the nanocellulose 3D matrix; in an in vitro maturation (IVM) procedure of oocytes and/or embryo in vitro production; or as reconstructed human epidermis used for efficacy and safety evaluation of cosmetic products, Park et al. teaches the production of bacterial cellulose from the KCG326 strain of Gluconacetobacter in a fermentation reaction with a carbon source (paragraph 0011) and a nitrogen source, which can be non-complex nitrogen sources, ammonium salt, ammonium sulfate, ammonium chloride, ammonium phosphate, or the like (paragraph 0024) at a temperature of 25-35oC and a culture period of 5-20 days (paragraph 0034); additionally, the nitrogen sources may also be used in combination (paragraph 0024). In regards to claims 35-36, where the culturing conditions are limited to 26oC for 4 days or 28oC for 10 days, Park et al. teaches the range of temperatures from 25-35oC for a culture period ranging from 5-20 days (paragraph 0034); further, Park et al. teaches the measurement of cellulose produced by Gluconacetobacter sp. over a range of 1-10 days (Fig. 1).
Park et al. do not, however, teach: 1) the specific combination of nitrogen sources (a) ammonium chloride and ammonium glutamate; and b) ammonium sulfate and ammonium nitrate), temperature (25oC-30oC), and culturing times (3-10 days); 2) producing a bacterial cellulose that undergoes absorption to introduce biological active molecules, the peptide component of an extracellular matrix; 3) including β-mercaptoethanol; 4) and further, introducing said β-mercaptoethanol, to the microstructure for in vitro maturation of oocytes and/or embryos in vitro production.
Regarding the specific combination of nitrogen sources (a) ammonium chloride and ammonium glutamate; and b) ammonium sulfate and ammonium nitrate, temperature (25oC-30oC), and culturing times (3-10 days) - routine optimization to determine the optimal working conditions of an invention is not non-obvious. The MPEP states, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP Section 2144.05.
Regarding the production of a bacterial cellulose that undergoes absorption to introduce biological active molecules, the peptide component of an extracellular matrix, Zhang et al. teaches the production of a bacterial cellulose from Acetobacter xylinum as a skin tissue repair material with good biocompatibility, mechanical strength, flexibility, breathability, and water retention (p. 3, Summary of Invention, paragraph 1), where said nanocellulose membrane is placed into a container with a composition of chitosan, collagen, and/or silk fibroin for their absorption into the structure (p. 3-4, Summary of Invention, step 4), making an “artificial skin for the treatment of burns, scalds and refractory ulcers with broad clinical and scientific research significance (p.1. 3rd paragraph).
Regarding the introduction of said β-mercaptoethanol, to the microstructure for in vitro maturation of oocytes and/or embryos in vitro production, Agarwal et al. teach that a 3D cell culture biomimetic can be used to grow both follicular cells and produce oocytes, where they specifically engineer alginate collagen scaffolds with cellulose to grow follicular cells and subsequently oocytes to culture follicular cells in vitro and determine if oocytes can develop (p. 3, paragraph 2, p. 5 paragraph 3, p. 6, bottom of the page). Additionally, Choe et al. teaches that β-mercaptoethanol addition to in vitro porcine embryos promotes increased development to later blastocyst stages, increasing cell number, due to its anti-oxidant functions (abstract).
Therefore, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to combine the teachings of Park et al., Zhang et al., and Agarwal et al. and Choe et al. to produce a bacterial nanocellulose from Gluconacetobacter sp., where said bacterial nanocellulose undergoes an absorption step introducing extracellular matrix peptides to the microstructure to engineer a nanocellulose 3D matrix similar to that of human skin as taught by Zhang et al. and a bacterial nanocellulose with β-mercaptoethanol for the in vitro maturation of oocytes/embryos of the instant claims because bacterial nanocellulose is a preferable 3D cell culture scaffold. One would be motivated to combine these teachings to arrive at the instant claims to mimic human skin, ensuring “biocompatibility, mechanical strength, flexibility, breathability, and water retention” as taught above by Zhang et al. and because Park et al. suggest Gluconacetobacter sp. cellulose can be utilized for skin tissue repair, as well (paragraph 0037). Additionally, one would be motivated to utilize a bacterial nanocellulose with β-mercaptoethanol for the in vitro maturation oocytes/embryos because 3D cell cultures allow cells and tissues to interact dynamically with the physical and chemical cues present in their microenvironment whereas current 2D cell cultures differ substantially from the in vivo microenvironment of most cells and tissues as taught by Argawal et al. (p. 2). There would be a reasonable expectation of success, yielding no surprising results when combining the teachings of Park et al. with that of Zhang et al. and Argawai et al. and Choe et al. because bacterial nanocellulose is already known to absorb extracellular matrix peptides and function as an artificial skin for a variety of uses and has the ability to absorb β-mercaptoethanol in particular for the growth of 3D embryonic cell cultures.
Applicant’s Arguments and Examiner’s Rebuttal:
The Applicant traverses the previous rejection of record of Claims 11 and 35-36 as being unpatentable over Park et al., Zhang et al., and Agarwal et al. and Choe et al.
First, the applicant argues that the examiner presents a conclusory statement because the examiner states that the specific combinations of nitrogen sources, temperature, and culturing times are routine optimization as they are general conditions disclosed in the prior art. However, the examiner respectfully disagrees, since culturing conditions are well-known in the art, where the MPEP clearly states:
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP Section 2144.05.
The examiner, therefore, contends that there is no need for prior art demonstrating the modulation of culturing conditions as optimization. Additionally, as stated in the above rejection:
”Park et al. teaches the production of bacterial cellulose from the KCG326 strain of Gluconacetobacter in a fermentation reaction with a carbon source (paragraph 0011) and a nitrogen source, which can be non-complex nitrogen sources, ammonium salt, ammonium sulfate, ammonium chloride, ammonium phosphate, or the like (paragraph 0024) at a temperature of 25-35oC and a culture period of 5-20 days (paragraph 0034).”
As such, the recitation of a carbon source, a nitrogen source, a range temperature, and culture period are obvious as per the MPEP, as cited above. Additionally, the temperature and culturing conditions disclosed in Park et al. are overlapping ranges with the instant claim, which are obvious. See MPEP 2144.05 (I).
Second, the applicant argues that Zhang et al. teaches an artificial skin for treatment of burns, scalds, and refractory ulcers; whereas the current teachings relate to an artificial skin for the testing and efficacy and safety of cosmetics and drugs and further as a platform for fertilization in vitro. The examiner agrees insofar of the recitation of the teachings; however, since Zhang et al. was utilized in an obviousness rejection and not an anticipation rejection, the intention of Zhang et al. is not necessary in the obviousness type rejection recited above. Additionally, there is motivation to combine the two references, where specifically as stated in the maintained rejection above, “One would be motivated to combine these teachings to arrive at the instant claims to mimic human skin, ensuring “biocompatibility, mechanical strength, flexibility, breathability, and water retention” as taught above by Zhang et al. and because Park et al. suggest Gluconacetobacter sp. cellulose can be utilized for skin tissue repair, as well (paragraph 0037).”
Third, the applicant argues that the claim limitation of claim 11 to include fermenting Gluconacetobacter sp. in the modulating step is not taught. However, the respectfully disagrees and contends that Park et al. does teach this limitation, since it teaches the production of bacterial cellulose from the KCG326 strain of Gluconacetobacter in a fermentation reaction, where conditions are modulated, i.e. the carbon source, nitrogen source, temperature, and culturing time (paragraphs 11, 24, 34, and Fig. 1).
The examiner is does not find the arguments presented by the applicant persuasive, and for these reasons, the rejections of record above apply.
Conclusion
8. All claims are rejected.
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.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571) 272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656