DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The terminal disclaimer filed on March 2, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11,951,122 B2 has been reviewed and is NOT accepted. The terminal disclaimer does not comply with 37 CFR 1.321 because: This application was filed on or after September 16, 2012. The party identified in the terminal disclaimer is not the applicant of record. A request to change the applicant under 37 CFR 1.46(c) must be filed and must include an application data sheet specifying the applicant in the applicant information section and comply with 37 CFR 3.71 and 3.73. To be reconsidered, the terminal disclaimer must be filed with the request under 37 CFR 1.46(c).
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.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi et al (US 2015/0297469 A1) in view of Gatenholm (US 2017/0368225 A1), Yamaguchi et al (JP2009-179913A and its English translation), Hogsett et al (US 2020/0157581 A1) and Tanioka (JP2008-50595A and its English translation) (with (i) Ougiya et al (“Relationship between Suspension Properties and Fibril Structure of Disintegrated Bacterial Cellulose”, Bioscience, Biotechnology, and Biochemistry, Vol.62(9) (1998), pg.1714-1719), which is being cited here merely to support the Examiner’s assertion that the optical density of a suspension of a solid material is related to the wavelength of light and the diameter of the solid material particles; (ii) “High Quality Gold Nanoparticles for Better Results” (an internet article by Nano Hybrids obtained from the website https://nanohybrids.net/pages/differences-between-optical-density-absorbance-and-extinction-of-gold-nanoparticles), which is being cited here merely to support the Examiner’s assertion that optical density is directly proportional to concentration of the nanoparticles in a nanoparticle solution; and (iii) Li et al (“Solute Concentration-Dependent Contact Angle Hysteresis and Evaporation Stains”, Langmuir, vol.30 (26) (2014), pg.7716-7723), which is being cited here merely to support the Examiner’s assertion that the contact angle of a liquid drop on a surface depends on the type of solute and concentration of the solute in the liquid drop).
Hayashi teaches (claim 1 and [0047]) a cosmetic additive containing cellulose fibers having an average diameter of 0.001-0.05 mm (i.e., 1-50 nm), and a ratio of L/D (an aspect ratio) of 5-500. Specifically, in Production Example 3 (“Production of Cellulose Fibers Derived from Bacterial Cellulose”), Hayashi teaches an aqueous dispersion of cellulose fibers derived from bacterial cellulose, and as shown in Table 1, the average diameter of the bacterial cellulose fibers is 36 nm; the average length is 2470 nm; and the aspect ratio (L/D) is 69: The average length 2470 nm falls within instant range (2000-3000 nm) for the biocellulose length and thus teaches instant range, and the aspect ratio 69 falls within instant range (66-150) for the biocellulose aspect ratio and thus teaches instant range. Although the average diameter of the bacterial cellulose fibers is 36 nm in Hayashi’s production example, as discussed above, Hayashi gives general teaching that the average diameter of its inventive cellulose fibers can range anywhere from 1 nm to 50 nm (preferably from 10 nm to 50 nm), and this range overlaps with instant range (20-30 nm) for the biocellulose diameter, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, Hayashi teaches a cellulose composition comprising plurality of biocelluloses formed by bacteria having an average diameter range (10-50 nm) which renders obvious instant diameter range (20-30 nm) of claim 1, an average length (2470 nm) which teaches instant length range (2000-3000 nm) of claim 1 and an aspect ratio (69) which teaches instant aspect ratio range (66-150) of claim 6; and a liquid medium.
With respect to instant limitation of claims 1 and 6 “wherein bacteria is at least one genus selected from the group consisting of Gluconacetobacter, Acetobacter, Rhizobium, Sarcina, Pseudomonas, Achromobacter, Alcaligenes, Enterobacter, Azotobacter and Agrobacterium”, Hayashi is silent as to what kind of bacteria are used to produce its bacterial cellulose. As evidenced by Gatenholm (see [0029]), Acetobacter, Rhizobium, Sarcina, Gluconacetobacter, Pseudomonas, Achromobacter, Alcaligenes, Enterobacter, Azotobacter and Agrobacterium are well known in the art as preferred examples of bacteria that produces bacterial cellulose. It would have been obvious to one skilled in the art to use one of the well-known bacteria as listed by Gatenholm to produce Hayashi’s bacterial cellulose with a reasonable expectation of success. Thus, Hayashi in view of Gatenholm renders obvious instant limitation.
With respect to instant limitation of claim 1 and 6 “wherein the plurality of the biocelluloses are in an amount of from 0.5% by weight to 1.2% by weight, based on a total weight of the cellulose composition”, Hayashi teaches ([0043]) that the concentration of cellulose in the aqueous dispersion during the refining (pulverization) process ranges from 0.1% by mass to 30% by mass (preferably 1% by mass to 10% by mass). At below 0.1%, the productivity is low ([0045]), and at above 30%, the pulverization efficiency decreases and the desired cellulose fibers are not obtained. It would have been obvious to one skilled in the art to have the bacterial cellulose concentration to be in the range of 0.1-30% by mass (or preferably 1-10% by mass) in Hayashi so as to obtain pulverization efficiency and desired cellulose fibers. Such range overlaps with instant range of 0.5-1.2% by weight, thus rendering instant range prima facie obvious. In re Wertheim, supra. Alternatively, Hayashi further teaches ([0046]) that when the cellulose concentration ranges 0.1-1% by mass, the number or processing times is about 10-100 to achieve sufficient refinement whereas if it is 1-10% by mass, the processing times need to be about 10-1,000. It would have been obvious to one skilled in the art to have the bacterial cellulose concentration to be in the range of 0.1-1% by mass in Hayashi so as to limit the number of processing times to be less than 100. Such concentration range overlaps with instant range of 0.5-1.2% by weight, thus rendering instant ranges prima facie obvious. In re Wertheim, supra. Thus, Hayashi teaches instant limitation.
With respect to instant limitation of the independent claim 6 (and also of claim 3) as to the OD620 value that ranges from 0.29 to 1.22, Hayashi does not explicitly teach instant OD620 value. However, as evidenced by Ougiya et al (see pg.1716, left-hand column, 2nd paragraph), the optical density of a suspension of a solid material is related to the wavelength of light and the diameter of the solid material particles. Also, as evidenced by “High Quality Gold Nanoparticles for Better Results” (an internet article by Nano Hybrids), optical density is directly proportional to concentration of the nanoparticles in a nanoparticle solution (or dispersion). Since Hayashi’s bacterial cellulose has a diameter range of 1-50 nm (preferably from 10 nm to 50 nm), which overlaps with instant range of 20-30 nm, and since a solid content concentration of Hayashi’s bacterial cellulose in an aqueous dispersion is taught to be 0.1-30% by mass or 0.1-1% by mass, which overlaps with instant range of 0.5-1.2 wt.%, it follows that the OD620 value for bacterial cellulose of Hayashi’s compositions would at least overlap with instant range 0.29-1.22 of claims 6 and 3 (as well as instant OD620 range 0.43-1.22 as recited in claim 4). Thus, Hayashi renders obvious instant limitation.
With respect to instant limitation of claims 1 and 6 “wherein the plurality of the biocelluloses is treated with swelling treatment liquid . . . wherein the swelling treatment liquid is at least one selected from the group consisting of an inorganic salt solution and an aqueous ionic liquid solution”, in Hayashi’s Production Example 3, commercially available bacterial cellulose was pulverized using a mixer. Then the resulting slurry was filtered and dispersed in pure water, and these steps were repeated until the pH became neutral. The resulting dispersion of bacterial cellulose was subjected to a pulverization treatment 30 times at 200 MPa using a high-pressure pulverization device to obtain an aqueous dispersion of bacterial cellulose fibers. Hayashi does not teach instant limitation of treating the biocellulose with swelling treatment liquid chosen from an inorganic salt solution or an aqueous ionic liquid solution. Yamaguchi teaches ([0015], [0032] and [0019]-[0020]) an efficient method for producing fine fibers of cellulose, in which the cellulose raw material is first dispersed in a solution containing an ionic liquid and the raw material is allowed to swell or partially dissolve while standing or under stirring and then defibrated by homogenization. In cellulose raw materials that have been swollen with the ionic liquid solution, the bonds between the fine fibers are weakened, thus making defibration by mechanical treatment easy and thereby reducing damage to the fine fibers. (i) Although Yamaguchi does not explicitly teach that the ionic liquid pre-treatment can be used with a biocellulose, as evidenced by Hogsett ([0502], [0507], [0508] and [0511), it is already known in the art that cellulosic-containing material, such as bacterial cellulose, can be pre-treated with ionic liquid. (ii) Yamaguchi does not teach that its ionic liquid solution is an aqueous mixture. Yamaguchi teaches ([0027]) that the ionic liquid (such as 1-butyl-3-methylimidazolium chloride) is contained in a solvent such as methanol, ethanol or N,N-dimethylacetamide. Tanioka teaches ([0004], [0032] and [0027]) that a dissolving solvent capable of dissolving cellulose, such as plant or bacterial cellulose, may be one of the following: (1) a two-component solvent consisting of an ionic liquid and water; (2) a two-component solvent consisting of an ionic liquid and a water-miscible organic solvent; or (3) a three-component solvent consisting of an ionic liquid, water and a water-miscible organic solvent. Tanioka further teaches ([0019] and [0026])) that a preferred ionic liquid is 1-butyl-3-methylimidazolium chloride and the preferred water-miscible organic solvent are methanol, ethanol and dimethylacetamide. Since Tanioka teaches the equivalence of using an ionic liquid (such as 1-buty-3-methylimidazolium chloride) and a water-miscible organic solvent (such as methanol, ethanol or N,N-dimethylacetamide) and using an ionic liquid, water and a water-miscible organic solvent, and since it is known in the art that cellulosic-containing material, such as bacterial cellulose, can be pre-treated with ionic liquid (as evidenced by Hogsett), it would have been obvious to one skilled in the art to pre-treat Hayashi’s commercially obtained bacterial cellulose by dispersing it in a solution containing ionic liquid, water and a water-miscible organic solvent (such solution teaches instant aqueous ionic liquid solution) to allow the bacterial cellulose to swell before the pulverization step (using a mixer) so as to weaken the bonds between the fibers, thus making defibration (pulverization) easier (leading to less number of pulverization treatments) and reducing the damage to the fibers as taught by Yamaguchi. Thus, Hayashi in view of Yamaguchi, Hogsett and Tanioka renders obvious instant limitation.
With respect to instant limitation of claims 1 and 6, “wherein the plurality of the biocelluloses . . . does not agglomerate”, Hayashi teaches ([0031]) that its cosmetic additive containing cellulose fibers does not deposit an agglomerate. Thus, Hayashi teaches instant limitation.
Thus, Hayashi in view of Gatenholm, Yamaguchi, Hogsett and Tanioka renders obvious instant claims 1-4, 6 and 7 (since Hayashi in view of Gatenholm, Yamaguchi, Hogsett and Tanioka teaches or renders obvious all the elements of instant cellulose composition, it is the Examiner’s position that the cellulose composition taught by Hayashi in view of the other cited prior arts would naturally be capable of being used on the skin and would naturally improve absorption and transmission efficiency of its contents when applied on the skin surface as instantly recited).
With respect to instant claims 5 and 8, Hayashi does not explicitly teach presently claimed contact angle range (95.5o – 107o). However, as evidenced by Li et al (see abstract), the presence of non-volatile solutes in a liquid drop on a solid surface affects the wetting properties; that is, the contact angle of the liquid drop on the surface depends on the type of solute and concentration of the solute in the liquid drop. Since Hayashi teaches instant biocellulose, and since the solid content of bacterial cellulose (in water) in Hayashi is taught to be 0.1-1 wt.% (as explained above), which overlaps with (and thus renders obvious) instant biocellulose concentration range (0.5-1.2 wt.%) of claims 1 and 6, it follows that the contact angle of Hayashi’s compositions with a surface of a sealing wax film would at least overlap with instant range of claims 5 and 8. Thus, Hayashi in view of Gatenholm, Yamaguchi, Hogsett and Tanioka renders obvious instant claims 5 and 8.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 6-11 of copending Application No. 17/390,048 (reference application, which is now US 11,951,122 B2) in view of Yamaguchi et al (JP2009-179913A and its English translation), Hogsett et al (US 2020/0157581 A1) and Tanioka (JP2008-50595A and its English translation). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Claims 1 and 3 of App.’048 teach a composition containing (i) a fiber formed of b-1,4-glucan (instant biocellulose) and having a diameter of 15-35 nm, a mean length of 1.5-3.5 mm, an aspect ratio of 60-150 and (ii) a carrier. Such ranges for the diameter, mean length and the aspect ratio overlap with instant ranges for the diameter, length and the aspect ratio as claimed in instant claims 1 and 6, thus rendering instant ranges prima facie obvious. In re Wertheim, supra. Claims 6-7 of App.’048 teaches that the composition is administered to a subject in a form of fibers with a liquid medium (water). Claim 8 of App.’048 teaches that the fiber is in a range of 0.2-1.2 wt.% based on a total weight of the composition, and such range overlaps with instant range (0.5-1.2 wt.%) of claims 1 and 6, thus rendering instant range prima facie obvious. In re Wertheim, supra. Claims 9-10 of App.’048 teaches that the composition comprises 0.1 mL of water with OD620 between 0.4 and 1.22, and such range overlaps with instant OD620 ranges of claims 3, 4 and 6, thus rendering instant ranges prima facie obvious. In re Wertheim, supra. Claim 11 of App.’048 teaches that the fiber formed of b-1-4-glucan is formed by bacteria chosen from Gluconacetobacter, Acetobacter, Rhizobium, Sarcina, Pseudomonas, Achromobacter, Alcaligenes, Enterobacter, Azotobacter or Agrobacterium (which are the same bacteria specified in present specification). Since claims 1, 3 and 6-11 of App.’048 teaches instant cellulose composition of claims 1 and 6 (including biocelluloses formed by the same bacteria mentioned in present specification), it is the Examiner’s position that plurality of b-1,4-glucan (instant biocellulose) naturally would not agglomerate.
With respect to instant limitation of claims 1 and 6 “wherein the plurality of the biocelluloses is treated with swelling treatment liquid . . . wherein the swelling treatment liquid is at least one selected from the group consisting of an inorganic salt solution and an aqueous ionic liquid solution”, claims of 17/390,048 do not teach instant limitation. Yamaguchi teaches ([0015], [0032] and [0019]-[0020]) an efficient method for producing fine fibers of cellulose, in which the cellulose raw material is first dispersed in a solution containing an ionic liquid and the raw material is allowed to swell or partially dissolve while standing or under stirring and then defibrated by homogenization. In cellulose raw materials that have been swollen with the ionic liquid solution, the bonds between the fine fibers are weakened, thus making defibration by mechanical treatment easy and thereby reducing damage to the fine fibers. (i) Although Yamaguchi does not explicitly teach that the ionic liquid pre-treatment can be used with a biocellulose, as evidenced by Hogsett ([0502], [0507], [0508] and [0511), it is already known in the art that cellulosic-containing material, such as bacterial cellulose, can be pre-treated with ionic liquid. (ii) Yamaguchi does not teach that its ionic liquid solution is an aqueous mixture. Yamaguchi teaches ([0027]) that the ionic liquid (such as 1-butyl-3-methylimidazolium chloride) is contained in a solvent such as methanol, ethanol or N,N-dimethylacetamide. Tanioka teaches ([0004], [0032] and [0027]) that a dissolving solvent capable of dissolving cellulose, such as plant or bacterial cellulose, may be one of the following: (1) a two-component solvent consisting of an ionic liquid and water; (2) a two-component solvent consisting of an ionic liquid and a water-miscible organic solvent; or (3) a three-component solvent consisting of an ionic liquid, water and a water-miscible organic solvent. Tanioka further teaches ([0019] and [0026])) that a preferred ionic liquid is 1-butyl-3-methylimidazolium chloride and the preferred water-miscible organic solvent are methanol, ethanol and dimethylacetamide. Since Tanioka teaches the equivalence of using an ionic liquid (such as 1-buty-3-methylimidazolium chloride) and a water-miscible organic solvent (such as methanol, ethanol or N,N-dimethylacetamide) and using an ionic liquid, water and a water-miscible organic solvent, and since it is known in the art that cellulosic-containing material, such as bacterial cellulose, can be pre-treated with ionic liquid (as evidenced by Hogsett), it would have been obvious to one skilled in the art to pre-treat b-1,4-glucan (which is a biocellulose) of claims of App.’048 by dispersing it in a solution containing ionic liquid, water and a water-miscible organic solvent (such solution teaches instant aqueous ionic liquid solution) to allow the b-1,4-glucan to swell so as to weaken the bonds between the fibers, thus making defibration (pulverization) easier and reducing the damage to the fibers as taught by Yamaguchi. Thus, claims of 17/390,048 in view of Yamaguchi, Hogsett and Tanioka renders obvious instant limitation.
Thus, claims 1, 3 and 6-11 of App.’048 in view of Yamaguchi, Hogsett and Tanioka renders obvious instant claims 1-8 (since claims 1, 3 and 6-11 of App.’048 in view of Yamaguchi, Hogsett and Tanioka teach all the elements of instant cellulose composition of claims 1 and 6, it is the Examiner’s position that the composition taught in claims of App.’048 in view of Yamaguchi, Hogsett and Tanioka would naturally improve absorption and transmission efficiency of its contents when applied on the skin surface as recited in claims 1 and 6 and would also naturally have instant contact angle range of claims 5 and 8).
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7 and 9-11 of copending Application No. 17/455,033 (reference application, which is now US 12,220,425 B2) in view of Yamaguchi et al (JP2009-179913A and its English translation), Hogsett et al (US 2020/0157581 A1) and Tanioka (JP2008-50595A and its English translation). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Claims 1, 3, 7 and 8 of App.’033 teach a composition containing (i) a fiber formed of b-1,4-glucan (instant biocellulose) and having a diameter of 15-35 nm, a mean length of 1.5-3.5 mm, an aspect ratio of 60-150, and (ii) a carrier (a liquid medium which is water). Such ranges for the diameter, mean length and the aspect ratio overlap with instant ranges for the diameter, length and the aspect ratio as claimed in instant claims 1 and 6, thus rendering instant ranges prima facie obvious. In re Wertheim, supra. Claims 7 and 9 of App.’033 teach that the fibers are present in the amount of 0.2-1.2 wt.%, and such range overlaps with instant range (0.5-1.2 wt.%) of claims 1 and 6, thus rendering instant range prima facie obvious. In re Wertheim, supra. Claims 10-11 of App.’033 teaches that the composition comprises 0.1 mL of water with OD620 between 0.4 and 1.22, and such range overlaps with instant OD620 ranges of claims 3, 4 and 6, thus rendering instant ranges prima facie obvious. In re Wertheim, supra. Claim 12 of App.’033 teaches that the fibers formed of b-1-4-glucan are formed by bacteria chosen from Gluconacetobacter, Acetobacter, Rhizobium, Sarcina, Pseudomonas, Achromobacter, Alcaligenes, Enterobacter, Azotobacter or Agrobacterium (which are the same bacteria specified in present specification). Since claims 1, 3 and 7-12 of App.’033 teaches instant cellulose composition of claims 1 and 6 (including biocelluloses formed by the same bacteria mentioned in present specification), it is the Examiner’s position that plurality of b-1,4-glucan (instant biocellulose) in claims of App.’033 naturally would not agglomerate.
With respect to instant limitation of claims 1 and 6 “wherein the plurality of the biocelluloses is treated with swelling treatment liquid . . . wherein the swelling treatment liquid is at least one selected from the group consisting of an inorganic salt solution and an aqueous ionic liquid solution”, claims of 17/455,033 do not teach instant limitation. Yamaguchi teaches ([0015], [0032] and [0019]-[0020]) an efficient method for producing fine fibers of cellulose, in which the cellulose raw material is first dispersed in a solution containing an ionic liquid and the raw material is allowed to swell or partially dissolve while standing or under stirring and then defibrated by homogenization. In cellulose raw materials that have been swollen with the ionic liquid solution, the bonds between the fine fibers are weakened, thus making defibration by mechanical treatment easy and thereby reducing damage to the fine fibers. (i) Although Yamaguchi does not explicitly teach that the ionic liquid pre-treatment can be used with a biocellulose, as evidenced by Hogsett ([0502], [0507], [0508] and [0511), it is already known in the art that cellulosic-containing material, such as bacterial cellulose, can be pre-treated with ionic liquid. (ii) Yamaguchi does not teach that its ionic liquid solution is an aqueous mixture. Yamaguchi teaches ([0027]) that the ionic liquid (such as 1-butyl-3-methylimidazolium chloride) is contained in a solvent such as methanol, ethanol or N,N-dimethylacetamide. Tanioka teaches ([0004], [0032] and [0027]) that a dissolving solvent capable of dissolving cellulose, such as plant or bacterial cellulose, may be one of the following: (1) a two-component solvent consisting of an ionic liquid and water; (2) a two-component solvent consisting of an ionic liquid and a water-miscible organic solvent; or (3) a three-component solvent consisting of an ionic liquid, water and a water-miscible organic solvent. Tanioka further teaches ([0019] and [0026])) that a preferred ionic liquid is 1-butyl-3-methylimidazolium chloride and the preferred water-miscible organic solvent are methanol, ethanol and dimethylacetamide. Since Tanioka teaches the equivalence of using an ionic liquid (such as 1-buty-3-methylimidazolium chloride) and a water-miscible organic solvent (such as methanol, ethanol or N,N-dimethylacetamide) and using an ionic liquid, water and a water-miscible organic solvent, and since it is known in the art that cellulosic-containing material, such as bacterial cellulose, can be pre-treated with ionic liquid (as evidenced by Hogsett), it would have been obvious to one skilled in the art to pre-treat b-1,4-glucan (which is a biocellulose) of claims of App.’033 by dispersing it in a solution containing ionic liquid, water and a water-miscible organic solvent (such solution teaches instant aqueous ionic liquid solution) to allow the b-1,4-glucan to swell so as to weaken the bonds between the fibers, thus making defibration (pulverization) easier and reducing the damage to the fibers as taught by Yamaguchi. Thus, claims of 17/455,033 in view of Yamaguchi, Hogsett and Tanioka renders obvious instant limitation.
Thus, claims 1, 3, and 7-12 of App.’033 in view of Yamaguchi, Hogsett and Tanioka renders obvious instant claims 1-8 (since claims 1, 3 and 7-12 of App.’033 in view of Yamaguchi, Hogsett and Tanioka teach all the elements of instant cellulose composition of claims 1 and 6, it is the Examiner’s position that the composition taught in claims of App.’033 in view of Yamaguchi, Hogsett and Tanioka would naturally improve absorption and transmission efficiency of its contents when applied on the skin surface as recited in claims 1 and 6 and would also naturally have instant contact angle range of claims 5 and 8).
Response to Arguments
Applicant argue that they discovered that biocellulose (formed by bacteria) having a diameter of 20-30 nm and a length of 2000-3000 nm yields unexpected results in terms of achieving stable dispersion of the biocellulose within a dispersion composition without agglomeration over extended periods as well as enhancing the absorption and transmission efficiency of its contents upon skin application.
Applicant first argue that present Example 2 (Test 2) demonstrates that the dispersion composition comprising biocellulose with the specified dimensions and concentrations remains stable without agglomeration for at least 3 days. The Examiner disagrees. First of all, there is no specified dimensions indicated for Samples Nos. 1-9. Applicant simply state in Test 2 that samples of the cellulose composition of various biocellulose contents were prepared “according to the method described above”, and in [0039] of US-PGPUB version or present application, applicant state that the mechanical grinding is carried out by diluting the dispersion with water and then grinding it with a horizontal ball mill device to fibrillate a surface of the biocellulose to have a diameter of from 20 to 30 nm and “a diameter” (the Examiner believes that applicant meant to say “a length” instead of “a diameter”) of from 2,000 to 3,000 nm, but nonetheless, Table 2 does not give actual values of the diameter and length for Samples Nos.1-9. Secondly, applicant did not show the criticality of instant range 0.5-1.2 wt.% for the biocellulose content because (i) both 0.3 wt.% and 0.4 wt.% of biocellulose content show no sedimentation for 3 days even though they both fall outside of the claimed range and (ii) applicant do not show any data point higher than the high end (i.e., 1.2 wt.%) of the claimed range. To establish unexpected results over a claimed range, applicant should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
Applicant further argue that present Example 4 (Test 4) illustrates superior processability, allowing the composition to be transformed into a frozen ingot. However, again, applicant do not show any data point higher than the high end (i.e., 1.2 wt.%) of the claimed range, and thus, the criticality of the claimed range (0.5-1.2 wt.%) for the biocellulose content is not shown. Besides, ability of the composition to be transformed into a frozen ingot is not a claimed feature of instant claims.
Applicant also argue that Examples 5 and 6 (Test 5 and Test 6) demonstrate that the biocellulose facilitates the transdermal absorption of L-ascorbic acid and arbutin, respectively. However, in Example 5, the concentration of biocellulose is 2 wt.%, which falls outside of the claimed range, and in Example 6, the concentration of biocellulose is 5 wt.%, which also falls outside of the claimed range. Also, again, applicant do not give actual values of the diameter and length of the biocellulose used in Examples 5 and 6.
Applicant’s argument involving Supplementary Experiment 1 was carefully considered but was found to be unpersuasive for the following reasons: First of all, although applicant state “[a]ttached hereto is a Declaration attesting to the authenticity and veracity of the supplemental experiments provided herein”, no such declaration was filed yet. Secondly, the comparison between Supplementary Experiment 1 (D = 25.13 nm and L = 2262 nm) and reproduction of Hayashi’s Production Example 3 (D = 3850 nm and L = 34.63 nm) is not a fair comparison because these two experiments were carried out in two completely different ways. That is, as already stated above, applicant argue that biocellulose (formed by bacteria) having a diameter of 20-30 nm and a length of 2000-3000 nm yields unexpected results in terms of achieving stable dispersion of the biocellulose within a dispersion composition without agglomeration over extended periods as well as enhancing the absorption and transmission efficiency of its contents upon skin application. Thus, in order to show unexpected results of having a diameter and a length of biocellulose in the claimed range in a fair manner, applicant need to carry out an experiment representing present invention and a comparative experiment where the only difference between the two are dimensions (diameter and length) of the biocellulose while carrying out the two experiments in the same way (e.g., starting out with the same bacteria, pre-treating the biocellulose (formed from the bacteria) with the same swelling treatment, etc.) except for the processes which control the diameter and length for the biocellulose. This way, one would be able to ascertain whether the unexpected superior results are due to having the diameter and length of the biocellulose in the claimed ranges (and not because of anything else). Thirdly, the Examiner also notes that in the stability experiment, the biocellulose content was 0.4 wt.% which falls outside of the claimed range (0.5-1.2 wt.%). Furthermore, even though the photograph for the stability experiment of the reproduced Production Example 3 of Hayashi appears turbid and white with low transparency, the actual Production Example 3 Hayashi has diameter of 36 nm; length of 2470 nm; and aspect ratio (L/D) is 69, which is very different than what applicant has reported (diameter of 34.63 nm and length of 3850 nm). Thus, the result shown for the reproduced production Example 3 of Hayashi does not represent the result of the actual Production Example 3 of Hayashi (besides, Hayashi already states ([0031]) that their biocelluloses do not agglomerate).
As to Supplementary Experiment 2 involving berberine penetration, the Examiner again notes that the tested biocellulose contents (2 wt.%, 4 wt.% and 6 wt.%) are outside of the claimed range. Furthermore, in both of the experiments involving berberine and glycyrrhizic acid, the comparison is between a composition with biocellulose and the active ingredient and a composition of the active ingredient without biocellulose. However, such experiment would not help overcome instant 103 rejection because Hayashi (in view of other cited prior arts) already teaches or renders obvious instant biocellulose.
Regarding instant rejection of claim 6, applicant argue that Hayashi’s ranges (5-500, 10-500 or 20-110) for the ratio for L/D are substantially broader than instant range of 66-150. Since the aspect ratio if a function of both fiber length and diameter, applicant argue that their augments above regarding the biocellulose diameter and length also apply here. For the same reasons explained above, the Examiner disagrees. Besides, in its Production Example 3, Hayashi’s Production Example 3, the aspect ratio (L/D) is 69, which falls within instant range of 66-150. As to applicant’s argument about instant limitation “the cellulose composition improves absorption and transmission efficiency of its contents when applied on the skin surface”, as already discussed above, since Hayashi in view of Gatenholm, Yamaguchi, Hogsett and Tanioka teaches or renders obvious all the elements of instant cellulose composition, it is the Examiner’s position that the cellulose composition taught by Hayashi in view of the other cited prior arts would naturally be capable of being used on the skin and would naturally improve absorption and transmission efficiency of its contents when applied on the skin surface as instantly recited.
With respect to instant double patenting rejections, although applicant state that they filed terminal disclaimers for 17/390,048 (US 11,951,122 B2) and 17/455,033 (US 12,220,425 B2), there is no terminal disclaimer found for 17/455,033 (US 12,220,425 B2). Also, as already discussed in Paragraph 2 above, the terminal disclaimer (filed on March 2, 2026) for 17/390,048 (US 11,951,122 B2) is NOT accepted.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
May 30, 2026
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