DETAILED ACTION
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 .
Support for the amendments is within the instant application specification.
Applicant’s amendment to the claims filed on 5/20/2026 in response to the Non-Final Rejection mailed on 2/25/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-7 are pending.
Applicant’s remarks filed on 5/20/2026 in response to the Non-Final Rejection mailed on 2/25/2026 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Withdrawn Rejections
The rejection of claims 5-7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of Applicant’s amendment of claim 5 to replace the term ‘BC’ with ‘bacterial cellulose.’
Maintained Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The rejection of claim 1-4 under 35 U.S.C. 103 as being unpatentable over Trexler et al (US 9,314,531 B2, Date of Patent: Apr. 19, 2016, cited on PTO-892 dated 2/25/2026) {herein Trexler} in view of Li et al (2018, Wiley Online Library, cited on PTO-892 dated 2/25/2026) {herein Li} is maintained.
Claims 1-4 are drawn to a composition for antibacterial bio-cellulosic patches comprising:[a] bacterial cellulose (BC) membrane; [b] mupirocin in the range of 0.00018% to 0.033% taken from mupirocin stock solution of concentration 50 mg/ml dissolved in methanol; and [c] glycerol in the range of 1.0% to 3.0%; wherein [b] and [c] are loaded onto [a].
With respect to claims 1-3, Trexler teaches antibacterial bio-cellulosic patches (column 2, lines 40-42) wherein the cellulose is comprised of bacterial cellulose (column 6, lines 45-50) . Said membrane comprises mupirocin (column 8, line 19). It is known by those of ordinary skill in the art that mupirocin is commonly prepared in methanol due to its high solubility in methanol. As such, it is the Examiner’s position that the mupirocin taught by Trexler would necessarily be taken from mupirocin stock solution that is dissolved in methanol. Absent evidence otherwise, it is the Examiner’s position that mupirocin is loaded into the membrane as Trexler teaches the membrane comprises mupirocin (column 8, line 19). Although the reference of Trexler does not explicitly teach the limitations of claim 2 (wherein 500 pg mupirocin is loaded onto 3100 mg of the bacterial cellulose membrane), claim 3 (wherein 0.0162% mupirocin is loaded onto the bacterial cellulose membrane), MPEP 2144.05 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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the concentrations of mupirocin and bacterial cellulose depending on the particular application. It would be routine for one to arrive at the concentrations for the application they intend on using the membrane. Therefore, the above invention would have been prima facie obvious. Trexler further teaches the cellulose that is used to make the hydrogel membrane can come from any source and can include commercial and non-commercial sources of cellulose (column 6, lines 37-39). Cellulose can be used from any microbial or bacterial source that produces it (column 6, lines 41-42). As such, absent evidence otherwise, it is the Examiner position that the bacterial cellulose membrane taught by Trexler is the same as the antibacterial bio-cellulosic patches recited in the instant application as both membranes are comprised of bacterial cellulose and mupirocin.
However, Trexler does not teach adding glycerol to the membrane (claim 1). Trexler does not teach the product of claim 4, wherein 2.5% glycerol is loaded onto the bacterial cellulose membrane (claim 4).
With respect to claims 1,4, Li teaches the preparation of bacterial cellulose membrane comprising glycerol as the glycerol acts as a carbon source (page 112, column 2, para 1). Although the references of Trexler in view of Li does not explicitly teach the limitations of claim 1 (mupirocin in the range of 0.00018% to 0.033% taken from mupirocin stock solution of concentration 50 mg/ml dissolved in methanol; and [c] glycerol in the range of 1.0% to 3.0%), claim 4 (wherein 2.5% glycerol is loaded onto the bacterial cellulose membrane), MPEP 2144.05 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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the concentrations of mupirocin and glycerol depending on the particular application. It would be routine for one to arrive at the concentrations for the application they intend on using the membrane. Therefore, the above invention would have been prima facie obvious.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Trexler et al. of a bacterial cellulose membrane (column 2, lines 40-42) wherein the cellulose is comprised of bacterial cellulose (column 6, lines 45-50) or combine the teachings of Li et al of a process for the preparation of bio-cellulosic patches comprising glycerol (page 110, column 2, para 2).
One of ordinary skill in the art would be motivated to either use the teachings of Trexler et al or combine the teachings of Li because Li provides Trexler with the motivation to add glycerol to the bacterial cellulose membrane loaded with the mupirocin antibiotic as the glycerol would acts as an efficient bio-renewable carbon source for microbial synthesis. One of ordinary skill in the art knowing the benefit of bacterial cellulose membranes based on the teachings of Trexler and Li would have a reasonable expectation of success that adding glycerol to the biocompatible cellulose hydrogel membrane containing mupirocin would result in the desired bacterial cellulose membrane as Li teaches the addition of glycerol to the bacterial cellulose membrane resulted in an increased bacterial cellulose concentration compared to using other carbon sources such as: glucose, fructose, maltose, sucrose, ect. (fig 3a). As such, one of ordinary skill in the art would expect a bacterial cellulose membrane comprised of glycerol to maintain a high bacterial cellulose concentration, thereby decreasing the costs associated with producing the bacterial cellulose membrane.
One of skill in the art would have a reasonable expectation of success to make and use the claimed antibacterial bio-cellulosic patches because Trexler provides the basic bacterial cellulose membrane and its uses and methods of making. While Li provides the teaching of bacterial cellulose membrane comprising the culturing of Komagataeibacter hansenii in media consisting of glycerol (page 110, column 2, para 2). Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Beginning on p. 2 of Applicant’s remarks, in summary, Applicant contends that the Office Action asserts that Li teaches the preparation of bio-cellulosic patches comprising glycerol as the glycerol acts as a plasticizer, enhancing the membrane's flexibility, toughness and durability. Applicant respectfully disagrees with the Office, specifically, in that neither Trexler nor Li teach the preparation of patches comprising glycerol acting as a plasticizer, enhancing the membrane's flexibility, toughness and durability. Li, however, does teach producing bacterial cellulose from Kombucha tea using in some cases glycerol in the growth media as a carbon source. It is unclear if Li leaves the glycerol with the bacterial cellulose or if there is any glycerol left as it is used as a carbon source.
The argument is not persuasive. Examiner acknowledges the teaching of Li of a bacterial cellulose membrane comprising glycerol as the glycerol acts as a carbon source (page 112, column 2, para 1). Examiner contends that Trexler would be motivated by the teachings of Li to use glycerol within the membrane as a carbon source for the production of antibacterial bio-cellulosic patches as Li teaches the addition of glycerol to the bacterial cellulose membrane results in an increased bacterial cellulose concentration compared to using other carbon sources such as: glucose, fructose, maltose, sucrose, etc. (fig 3a). Examiner contends that one of ordinary skill in the art would expect a bacterial cellulose membrane comprised of glycerol to maintain a high bacterial cellulose concentration, thereby decreasing the costs associated with producing the bacterial cellulose membrane.
The rejection of claims 5-7 under 35 U.S.C. 103 as being unpatentable over Li et al (2018, Wiley Online Library, cited on PTO-892 dated 2/25/2026) {herein Li} in view of Trexler et al (US 9,314,531 B2, Date of Patent: Apr. 19, 2016, cited on PTO-892 dated 2/25/2026) {herein Trexler} is maintained.
Claims 5-7 are drawn to a process for the preparation of the composition for antibacterial bio-cellulosic patches as claimed in claim 1, wherein the steps comprising: (a) culturing an isolated bacterial strain of Komagataeibacter hansenii (MBS-8) designated as MTCC 13036 in M5 medium comprising glucose 0.5%, glycerol 4%, peptone 0.5%, yeast extract 0.25%, disodium hydrogen phosphate 0.27%, citric acid 0.015% having pH in the range of 5.5 to 6.2 at a temperature ranging from 28 to 30 °C for a period of 7 to 9 days under static conditions to obtain a bacterial cellulose membrane on the surface of the medium; (b) the bacterial cellulose membrane obtained in step [a] was washed with boiled iN NaOH having a temperature in the range of 80 to 90°C- for a period of 1 to 2 hr. and then washed with a weak acid followed by washing with distilled water for 2-3 times until the pH becomes neutral; (c) the washed bacterial cellulose membrane obtained in step [b] was dipped in distilled water and autoclaved at a temperature of 115 to 120 degree C for 15 to 20 minutes to obtain a sterilized BC bacterial cellulose membrane; (d) the -sterilized bacterial cellulose membrane was weighed and then compressed by hands between two acrylic plates for the removal of 50-60% of their water content to obtain a drained bacterial cellulose membrane; (e) the drained bacterial cellulose membrane obtained in step [d] was soaked in potassium phosphate buffered solution having pH 7.4 containing mupirocin in the range of 50 to 1000 microgram and glycerol in the range of 0.5 to 5.0% for a duration of 24 to 48 hours at room temperature to assure complete absorption of the drug onto the bacterial cellulose membrane; and (f) after the drug absorption, the a bacterial cellulose membrane obtained was dried at temperature ranging from 30 to 40 0C in a ventilated oven for 10 to 16 hours to obtain the desired antibacterial bio-cellulosic patch.
With respect to claims 5-6, Li teaches a process for the preparation of bacterial cellulose membrane comprising the culturing of Komagataeibacter hansenii JR-02 in media consisting of glucose, glycerol, citric acid, yeast extract, peptone (page 110, column 2, para 2) and Na2HPO4 (page 109, column 2, para 2). It would be obvious to one of ordinary skill in the art that Komagataeibacter hansenii JR-02 could be substitutes for Komagataeibacter hansenii MBS-8 as both strains produce cellulose. MPEP 2143.I.B states “The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art.” Li further teaches cultivation took place at 28C for 7 days (page 109. Column 2, para 4) under static conditions to obtain the bacterial cellulose (page 109, column 1, para 1) and the and pH was controlled at 5.00±0.01 (page 109, column 2, para 2). The medium should be blended with 2% (v/v) ethanol after sterilization, of which Examiner is interpreting as encompassing autoclaving (page 109, column 2, para 2).. Although the reference of Li does not explicitly teach the limitations of claim 5 (M5 medium comprising glucose 0.5%, glycerol 4%, peptone 0.5%, yeast extract 0.25%, disodium hydrogen phosphate 0.27%, citric acid 0.015% having pH in the range of 5.5 to 6.2… autoclaved at a temperature of 115 to 120 degree C for 15 to 20 minutes… mupirocin in the range of 50 to 1000 microgram and glycerol in the range of 0.5 to 5.0%... dried at temperature ranging from 30 to 40 °C for 10 to 16 hours…), claim 6 (culturing of the isolated bacterial strain MTCC 13036 is done at a temperature of 28 °C for 8 days), MPEP 2144.05 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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the concentration of components of the media, concentration of mupirocin and glycerol, temperature and time of drying the BC and cultivation of the isolated bacterial strain depending on the particular application. It would be routine for one to arrive at the concentration of components of the media, concentration of mupirocin and glycerol, temperature and time of drying the BC and bacterial cultivation temperature and duration for the application they intend on using the antibacterial bio-cellulosic patches/membranes. Therefore, the above invention would have been prima facie obvious. Li further teaches the cellulose material was rinsed in 0.1N NaOH at 100C for 30min (page 110, column 1, para 3). Absent evidence otherwise, it is the Examiner’s position that NaOH at 100C is the same as NaOH boiling as 100C is the temperature at which liquid boils. Next, the cellulose products were washed acetic acid (table 1) and then deionized water repeatedly until the pH of the water became neutral. Additionally, the samples were freeze-dried or oven-dried at 105C in petri dishes (page 110, column 2, para 1). Since the samples were freeze-dried or oven-dried at 105C in petri dishes, it is the Examiner’s position that said samples are sterilized since it is known by those of ordinary skill in that art that 105C is an effective temperature to kill most microbial contaminants. Regarding the recitation ‘(d) the sterilized bacterial cellulose membrane was weighed and then compressed by hands between two acrylic plates for the removal of 50-60% of their water content to obtain a drained BC membrane’ within the instant application claim 5, it would be obvious to one of ordinary skill in the art that one could compress the BC between two acrylic plates to remove 50-60% of the water content as said method of removing water from cellulose materials is routinely done as it is well-known in the art that the utilization of acrylic prohibits the sticking of the cellulose materials during the drying process. Furthermore, it is the Examiner’s position that the bacterial cellulose taught by Li is drained, as it would be free of water after being freeze-dried or oven dried.
With respect to claim 7, Li teaches the cellulose products were washed with acetic acid (table 1). The presence of acetic acid in the basal media could limit organic acid production and accumulation of bacteria and keep the culture in the optimal condition for bacterial cellulose production (page 114, column 1, para 2). In addition, adding acetate buffer in culture media was also an effective method to improve BC production (page 114, column 1, para 2). As such, it is the Examiner’s position that it would be obvious to one of ordinary skill in that art to substitute glacial acetic acid for acetic acid as one of ordinary skill in the art would expect glacial acid to better limit organic acid production and accumulation of bacteria due to its high purity, thereby improving the production of BC. MPEP 2143.B. recites, ‘the rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art.’
However, Li does not teach antibacterial bio-cellulosic patches (claim 5). Li does not teach a) culturing the isolated bacterial strain of Komagataeibacter hansenii (MBS-8) designated as MTCC 13036 (e) the drained BC membrane obtained in step [d] was soaked in potassium phosphate buffered solution having pH 7.4 containing mupirocin in the range of 50 to 1000 microgram and glycerol in the range of 0.5 to 5.0% for a duration of 24 to 48 hours at room temperature to assure complete absorption of the drug onto the membrane; and (f) after the drug absorption, the bacterial cellulose membrane obtained were dried at temperature ranging from 30 to 40 °C in a ventilated oven for 10 to 16 hours to obtain the desired bacterial cellulose membrane (claim 5). Li does not teach wherein culturing of the isolated bacterial strain MTCC 13036 is done at a temperature of 28 °C for 8 days (claim 6). Trexler does not teach wherein the weak acid is glacial acetic acid (claim 7).
With respect to claims 5-6, Trexler teaches a process for the preparation of antibacterial bio-cellulosic patches (column 2, lines 40-42) wherein the cellulose is comprised of bacterial cellulose (column 6, lines 45-50). Said membrane comprises mupirocin, which is an antibiotic (column 8, line 19). The membrane is soaked in PBS for 48 hrs (column 30, line 39) and dried at 40° C (column 30, line 18). It is known by those of ordinary skill in the art that mucin is commonly prepared in methanol due to its high solubility in methanol. As such, it is the Examiner’s position that the mupirocin taught by Trexler would necessarily be taken from mupirocin stock solution that is dissolved in methanol. Absent evidence otherwise, it is the Examiner’s position that mupirocin is loaded into the membrane as Trexler teaches the membrane comprises mupirocin (column 8, line 19). Furthermore, absent evidence otherwise, it is the Examiner’s position that the antibacterial bio-cellulosic patches taught by Trexler are the same as the antibacterial bio-cellulosic patches recited in the instant application since both patches are comprised of bacterial cellulose and mupirocin. Although the references of -----Trexler in view of Li do not explicitly teach the limitations of claim 6 (culturing of the isolated bacterial strain MTCC 13036 is done at a temperature of 28 °C for 8 days), MPEP 2144.05 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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the concentration of components of the media, concentration of mupirocin and glycerol, temperature and time of drying the BC and cultivation of the isolated bacterial strain depending on the particular application. It would be routine for one to arrive at the concentration of components of the media, concentration of mupirocin and glycerol, temperature and time of drying the BC and bacterial cultivation temperature and duration for the application they intend on using the antibacterial bio-cellulosic patches/membranes. Therefore, the above invention would have been prima facie obvious.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Li et al. of a process for the preparation of bacterial cellulose membranes comprising the culturing of Komagataeibacter hansenii in media consisting of glucose, glycerol, citric acid, yeast extract, peptone (page 110, column 2, para 2) and Na2HPO4 (page 109, column 2, para 2) or combine the teachings of Trexler because Trexler teaches a process for the preparation of antibacterial biocompatible cellulose membrane (column 2, lines 40-42) wherein the cellulose is comprised of bacterial cellulose (column 6, lines 45-50) and mupirocin (column 8, line 19).
One of ordinary skill in the art would be motivated to either use the teachings of Li et al. by itself or combine the teachings of Trexler because Trexler provides the motivation for Li to add mupirocin to the BC as said antibiotic is effective to either prevent or treat infection in the wound area, surrounding tissues, or systemically (column 7, lines 61-63). One of ordinary skill in the art knowing the benefit of mupirocin in BC based on the teachings of Li and Trexler would have a reasonable expectation of success that adding mupirocin to BC would allow for the controlled delivery of mupirocin to tissues that are covered with the bacterial cellulose (Trexler: column 7, lines 30-35). Additionally, mupirocin would be released overtime, resulting in a longer period of time for antibiotic delivery and more effective healing of infected tissues (Trexler: column 7, lines 30-35).
One of skill in the art would have a reasonable expectation of success to make and use the claimed antibacterial bio-cellulosic patches because Li provides the basic bacterial cellulose membranes and its uses and methods of making it. Whereas, Trexler provides the teaching of a process for the preparation of antibacterial cellulose membrane (column 2, lines 40-42) wherein the cellulose is comprised of bacterial cellulose (column 6, lines 45-50) and comprises mupirocin (column 8, line 19). Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Beginning on p. 2 of Applicant’s remarks, in summary, Applicant contends that there is nothing in either Li and/or Trexler alone or together about loading a bacterial cellulose membrane with glycerol but at best merely glycerol as a source of carbon during preparation of the bacterial cellulose itself.
The argument is not persuasive. Examiner contends that Li and Texler teach a composition for antibacterial bio-cellulosic patches comprising: bacterial cellulose membrane; mupirocin and glycerol. Examiner contends that all limitations are taught by the prior art Li and Trexler, therefore it would be obvious to one of ordinary skill in the art to combine the teachings of Li and Trexler as said composition would yield a predictable result of a composition for antibacterial bio-cellulosic patches. 2143.I.A states “the rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).”
Conclusion
Status of Claims
Claims 1-7 are pending.
Claim 1-7 are rejected.
No claims are in condition for allowance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Prosecution Insights