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 . Claims included in prosecution are claims 1-8, 11, & 19-21.
Previous Rejections
Applicants' arguments, filed 9/18/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claims 12-14 & 16-17 are objected to because of the following informalities: Claims 12-14 & 16-17 are withdrawn as recognized by the previous Office Action and Applicant’s response but appear to be inadvertently marked as “(Previously Presented)”, “(Original)”, and/or “(Currently Amended)”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claim(s) 1-8 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 5,922,379, Jul. 13, 1999) (hereinafter Wang). Wang teaches a biodegradable protein/starch-based thermoplastic composition (Abstract). The compositions preferably contain about 20 to 46 wt.% starch, about 8 to 20 wt.% water, about 5 to 25 wt.% plasticizer, about 0.5 to 2 wt.% lubricant, and other desired additives, such as coloring agents, modifiers, cross-linking reagents, and preservatives (satisfies claim 6) (col 2, line 57-65). The compositions are preferably mixed, extruded and pelletized (satisfies particles of claim 1) (col 2, line 66-67). The composition may be made using extrusion via twin screw or single screw extruders (satisfies extrusion of claim 1) (col 3, line 21-35). Suitable starches to be used in the composition include potato starch, rice starch, and/or a combination thereof (satisfies starch of claim 1-3) (col 3, line 53-58). Suitable plasticizers include sorbitol and mannitol (satisfies viscosity modifying agent of claim 1 & 4-5) (col 4, line 45-55). Water is also used as both a plasticizer and a blowing agent in the composition (satisfies water of claim 1) (col 4, line 58-59). Lubricants such as lecithin are preferably used to reduce the processing torque and lower energy input for processing (satisfies emulsifier of claim 1 & 7) (col 6, line 3-8). Coloring agents can be included in the compositions to produce articles of a desired color where suitable coloring agents include tartrazine (satisfies CI19140 of claim 8) (col 6, line 10-15). Suitable additives include, but are not limited to, flavoring agents (satisfies claim 19) (col 6, line 20-25).
The prior art is not anticipatory insofar as this combination must be selected from different lists/locations in the reference. Although, Wang does not exemplify a composition comprising potato/rice starch, sorbitol/mannitol, lecithin, and water, it does suggest such a combination since it discloses a composition where suitable starches include potato and/or rice starch, suitable plasticizers include sorbitol and/or mannitol, and suitable lubricants include lecithin; further comprising water. Therefore, it would have been obvious to one of ordinary skill in the art, prior to filing the instant application, to have used a mixture of potato/rice starch, sorbitol/mannitol, lecithin, and water in the disclosed amounts because Wang suggests using these components in mixture and since all the claimed elements were known in the prior art. 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. See MPEP § 2143 (I)(A).
Regarding claim 1 reciting color particles, as discussed above, Wang discloses wherein the composition is extruded and pelletized (satisfying particle) and wherein coloring agents can be included in the composition to yield the desired color. As such, it would have been reasonable for one of ordinary skill in the art to conclude that the resulting product of Wang would be in the form of colored particles.
Regarding the amount of starch and viscosity modifying agent recited in instant claim 1 (i.e., 50-98%), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Wang discloses that the amount of starch used is up to 46 wt.% and the amount of plasticizers, sorbitol or mannitol, is up to 25 wt.%. Combined these components constitute an amount of up to 71 wt.%. Accordingly, because the range recited in the instant claims overlaps with the range disclosed by Wang, the range disclosed by Wang meet the instantly recited limitations.
Regarding the amount of emulsifier and water recited in instant claim 1, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Wang discloses that the composition comprises about 8 to 20 wt.% water and about 0.5 to 2 wt.% lubricant such as lecithin. Accordingly, because the ranges recited in the instant claims overlaps with the ranges disclosed by Wang, the ranges disclosed by Wang meet the instantly recited limitations.
Regarding the amount of colorant recited in instant claim 1, 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. See MPEP 2144.05(II)(A). The amounts of coloring agents are a result effective variable, since amounts directly impact the resulting color of the composition. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of colorant to yield the desired color profile.
Regarding the amylopectin contents recited in instant claims 1-2 and 6 (i.e., at least 80% and/or at least 90%), as noted by par. [0172] of the instant specification, potato starch and rice starch have “an amylopectin content of at least 80%” and “an amylopectin content of at least 90%”. Therefore the rice and potato starch Wang meet the limitation of at least 80% and/or at least 90% of the instant claims.
Regarding the ratio of starch to viscosity modifying agent recited in instant claim 6, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Wang discloses that the amount of starch used is up to 46 wt.% and the amount of plasticizers, sorbitol or mannitol, is up to 25 wt.%. Accordingly, the claimed weight ratio would have been obvious from one of ordinary skill in the art selecting an amount of starch and an amount of sorbitol or mannitol from the above ranges and the ratio thereof overlapping with the claimed ratio.
Therefore, the teachings of Wang render obvious claim 1-8 and 19.
2. Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 5,922,379, Jul. 13, 1999) (hereinafter Wang) in view of Verbeek et al. (Materials Letters, 57, 1919 – 1924, 2003) (hereinafter Verbeek).
The teachings of Wang are discussed above.
Wang differs from the instant claim insofar as not disclosing a specific particle size for their pellets.
However, Verbeek discloses that particle size influences the mechanical properties of thermoplastic composites. In a study, thermoplastic composite particles smaller than 240 microns (i.e., 0.24 mm) had lower tensile strengths than the particles above 240 microns (Abstract).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant claims, to have modified the pellets of Wang to have a particle size of larger than 240 microns (i.e., 0.24 mm) motivated by the desire to achieve particles with higher tensile strength as taught by Verbeek.
Therefore, the combined teachings of Wang and Verbeek render obvious claim 11.
3. Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 5,922,379, Jul. 13, 1999) (hereinafter Wang) in view of Bond et al. (US 2014/0142226, May 22, 2014) (hereinafter Bond).
The teachings of Wang are discussed above.
Wang differs from the instant claim insofar as not disclosing wherein the composition comprises an odoriferous substance.
However, Bond teaches a starch thermoplastic composition (Abstract). The compositions can include an additive (¶ [0088]). Suitable additives include perfumes (¶ [0089]). The term "perfume" is used to indicate any odoriferous material (¶ [0090]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Wang discloses wherein the composition may contain additives. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Wang to comprise an odoriferous material, since it is a known additive for use in starch thermoplastics as taught by Bond.
Therefore, the combined teachings of Wang and Bond render obvious claim 20.
4. Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Magistrali et al. (US 2019/0021979, Jan. 24, 2019) (hereinafter Magistrali) as evidenced by Elephchem (The role of polyvinyl alcohol in cosmetics, Sep. 22, 2020) (hereinafter Elephchem) and Transparency Market Research (Organic Glycerin for Cosmetics Market, Apr. 19, 2024) (hereinafter Transparency). Magistrali discloses microgranules comprising destructurized starch for use in cosmetic, dermatological, detergent, and cleansing formulations (Abstract). The composition preferably comprises: i. 30-80% of destructurized starch; ii. 20-70% of polymers containing hydrophilic groups intercalated with hydrophobic sequences (satisfies viscosity modifying component of claim 21); iii. 0-25% of plasticizers; iv. 0-50% of water (¶ [0013-0017]). Preferred starches include native starches such as potato starch (satisfies starch of claim 21) (¶ [0018]). Suitable polymers include polyvinyl alcohol (¶ [0030]). Suitable plasticizers include glycerin (satisfies emulsifier of claim 21) (¶ [0039]). The microgranules may be prepared by a process involving extrusion (¶ [0047]). Suitable additives to components i.-iv. include pigments and coloring agents (satisfies colorant of claim 21) (¶ [0040]).
Magistrali differs from the instant claims insofar as not disclosing the exact amount of a coloring agent.
However, 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. See MPEP 2144.05(II)(A). The amounts of pigments and coloring agents are a result effective variable, since amounts directly impact the resulting color of the composition. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts of colorant to yield the desired color profile.
Regarding the viscosity modifying component recited in instant claim 21, as evidenced by Elephchem, polyvinyl alcohol is a thickening agent that affects the viscosity of cosmetics.
Regarding the emulsifier recited in claim 21, as evidenced by Transparency, glycerin is an excellent emulsifier for cosmetics (Pg. 2)
Regarding the amounts of starch, viscosity modifying component, emulsifier, and water recited in instant claim 21, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Magistrali’s microgranules contain i. 30-80% of destructurized starch; ii. 20-70% of polymers containing hydrophilic groups intercalated with hydrophobic sequences (satisfies viscosity modifying component of claim 21); iii. 0-25% of plasticizers; iv. 0-50% of water. Accordingly, because the ranges recited in the instant claims overlap with the ranges disclosed by Magistrali, ranges disclosed by Magistrali meet the instantly recited limitations.
Therefore, the teachings of Magistrali, as evidenced by Elephchem and Transparency, render obvious claim 21.
Response to Arguments
Regarding Applicant’s arguments that the art of record does not teach the amount of starch and viscosity modifying agent, the Examiner submits that the “50-98% by weight” required by instant claim 1 represents the total amount of starch and viscosity modifying component. As discussed above, Wang discloses that the amount of starch used is up to 46 wt.% and the amount of plasticizers, sorbitol or mannitol, is up to 25 wt.%. Combined these components constitute an amount of up to 71 wt.%. Accordingly, in view of this overlap, Wang does indeed disclose an amount of starch and viscosity modifying component that satisfies the instantly recited limitations.
Regarding Applicant’s Argument that Verbeek and Bond do not cure the alleged deficiencies of Wang, the Examiner submits that Verbeek cures any alleged deficiencies of Wang where Verbeek provides motivation for one of ordinary skill in the art to utilize particle sizes larger than 240 microns (i.e., 0.24 mm) in thermoplastic compositions. Bond further cures any alleged deficiencies of Wang where Bond discloses that odoriferous materials are a known additive for use in starch thermoplastics.
Regarding the allegations of unexpected results (page 7-8 of Applicant’s response), any differences between the claimed invention and the prior art may be expected to result in some difference in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The burden is on applicant to establish that the results are in fact really unexpected and of statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992). See also MPEP § 716.02.
Applicant does not appear to have discussed same with respect to objective data. Furthermore, Applicant’s data does not appear to be unexpected. For instance, Example 8 which exhibited color bleeding contained more than 3x the amount of water that Example 5 had. Significantly increasing the amount of solvent in a composition can be reasonably expected to materially affect color bleeding. Solvents, such as water, function to dissolve other substances and an increased solvent content would likely enhance the mobility of the colorant in the color particle. This is would probably make the color particles more susceptible to color bleeding since the color is likely migrating beyond its intended target. Accordingly, color particles with a higher solvent (i.e., water) content would logically be expected to exhibit greater color bleeding in comparison to a color particle with a lower water content. As such, one of ordinary skill in the art cannot conclusively determine that the change in starch is the only factor that resulted in the composition exhibiting increased color bleeding. Therefore, these findings do not appear to be “unexpected”.
Finally, assuming purely arguendo that unexpected results have been established, the probative value of the evidence as compared to the invention as claimed must then be determined, i.e., the claims must be “commensurate in scope” with the showing. MPEP § 716.02(d). See also MPEP § 2145. Applicant must explain the “manner in which the specific compositions illustrated are considered to be commensurate in scope with the claimed invention”; see Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992); see also MPEP 716.02, citing same.
For instance, Applicant’s claim 1 merely requires the presence of a starch, a viscosity modifying component, an emulsifier, and a colorant generically, and in very broad ranges. However, the example tested contain only very specific starches, viscosity modifying components, emulsifiers, and colorants, and in very specific amount. Namely, Example 5 contained: potato starch (72.1%), sorbitol (20%), monoglycerides (1.7%), and CI74160 (0.2%). As such, it is unclear if only this specific combination of components causes the alleged unexpected result, or if all starches, viscosity modifying components, emulsifiers, and colorants, and amounts thereof, encompassed by the instant claims do. Further, it is not clear if the results would vary if other starches, viscosity modifying components, emulsifiers, and colorants, and amounts thereof were used in place of potato starch, sorbitol, monoglycerides, and CI74160. In order for this to be established, potato starch, sorbitol, monoglycerides, and CI74160 must be reasonably representative of carotenoids and flavonoids in general. However, no evidence of this has been provided. As such, it would be difficult for one of ordinary skill in the art to ascertain whether potato starch, sorbitol, monoglycerides, and CI74160 would be representative of starches, viscosity modifying components, emulsifiers, and colorants. Accordingly, Applicant’s data is not commensurate in scope with the instant claims.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejection is maintained.
Conclusion
Claims 1-8, 11 & 19-21 are rejected.
Claims 12-14 & 16-17 are withdrawn.
No claims are allowed.
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 Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612