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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 12, 2026 has been entered.
Election/Restrictions
Claims 15, 26 and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 15, 2025.
Claim Objections
Claim 24 is objected to because of the following informalities:
In line 2, do Applicants intend to recite --of-- instead of “if”?
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 24 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 24, there is no express antecedent basis for “low-melting point” defining the support polymer.
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.
Claims 1-4, 6, 9, 11, 13, 16, 19-24 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0190279 (Guemard).
Guemard discloses a masterbatch comprising:
a liquid composition [0008-0011] which includes:
from 0.01 to 35 wt.% of a biological entity such as a protease, esterase or lipase enzyme (meets Applicants’ enzyme component);
from 15 to 95 wt.% of water (meets Applicants’ aqueous component); and
from 3 to 80 wt.% of a polysaccharide carrier powder (meets Applicants’ polysaccharide powder); and
a low melting point polymer such PCL, PBSA, PBAT, PHA or PLA [0154] (meets Applicants’ support polymer) (e.g., abstract, [0008-0019], [0032], [0049-0137], [0146-0148], [0154-0159], [0186-0190], examples, claims).
Notably, Guemard discloses [0148] that the enzyme water solution “is mixed with the carrier in a powder form”, that is, the enzyme aqueous solution and polysaccharide powder are introduced separately to form the liquid composition [0137]. Indeed, in the examples [0284], Guemard expressly discloses that Arabic gum in powder form is mixed with the enzyme aqueous solution. Illustratively, Guemard exemplifies [0284-0288] a masterbatch comprising Arabic gum, an enzyme and polycaprolactone (PCL) wherein the production method comprises:
(a) preparing a liquid composition by pre-mixing an enzyme aqueous solution Savinase 16L (meets Applicants’ enzymatic aqueous solution) with Arabic gum in powder from (meets Applicants’ polysaccharide powder) wherein said components would necessarily have been mixed in an agitating homogenizing vessel [0148] either simultaneously or consecutively at ambient temperature, i.e., less than the melting temperature of the PCL (meets Applicants’ step (a) and materials thereof);
(b) introducing the liquid composition via a pump [0192] into an extruder;
(c) introducing PCL into the extruder (meets Applicants’ step (b) and polymer thereof);
(d) mixing the components (meets Applicants’ step (c)); and
(d) recovering the masterbatch (meets Applicants’ step (d)).
In essence, Guemard’s exemplified method differs from claim 1 in that the enzyme aqueous solution and Arabic gum powder are not pre-mixed in the same compounding machine, e.g., extruder, used to introduce the PCL. It would have been within the purview of one having ordinary skill in the art to pre-mix Guemard’s enzyme aqueous solution and Arabic gum in the same mixer as used to introduce the PCL in the interest of efficiency, e.g., time-savings and minimizing number of compounding devices, with the reasonable expectation of success. Indeed, Guemard discloses the viability of using extruders having a main hopper and several successive zones wherein additional components may be added during the process [0191]. The selection of any order of performing process steps or mixing ingredients is prima facie obvious, in the absence of new or unexpected results, Ex parte Rubin, 128 USPQ 440, In re Gibson, 5 USPQ 230.
As to claim 2, the selection of any order of mixing ingredients is prima facie obvious, in the absence of new or unexpected results. Thus, it would have been within the purview of one having ordinary skill in the art to separately introduce Guemard’s enzyme aqueous solution and polysaccharide carrier at the same time, versus consecutively, with the reasonable expectation of success
As to claims 3 and 4, Guemard expressly exemplifies the polysaccharide Arabic gum [0284].
As to claim 6, Guemard’s liquid composition comprises:
- from 0.01 to 35 wt.% enzyme;
- from 15 to 95 wt.% water; and
- from 3 to 80 wt.% polysaccharide carrier.
As to claim 9, Guemard discloses mixing the enzyme aqueous solution and polysaccharide at an ambient temperature.
As to claim 11, it is within the purview of one having ordinary skill in the art to prepare Guemard’s liquid composition as rapidly as possible (inclusive of presently claimed mixing time) in the interest of time efficiency with the reasonable expectation of success.
As to claim 13, Guemard discloses introducing the PCL in molten form [0286].
As to claim 16, Guemard discloses [0189] a mixing time of between 5 seconds to 3 minutes, preferably less than 2 minutes. Thus, it would have been obvious to one having ordinary skill in the art to carry out the mixing of the PCL within the presently claimed time range with the reasonable expectation of success.
As to claims 19 and 20, Guemard expressly discloses, and renders obvious to one having ordinary skill in the art, the further addition of calcium carbonate [0099] for its expected additive effect.
As to claim 21, Guemard expressly exemplifies an extruder [0286].
As to claim 22, Guemard discloses the use of extruders having a main hopper and several successive heating zones wherein the components may be added at different times and temperatures during the process [0191]. Thus, it would been within the purview of one having ordinary skill in the art to use an extruder with at least four zones to enable the successive addition of the various components with the reasonable expectation of success.
As to claim 23, Guemard expressly exemplifies the production of a granulated masterbatch composition [0287].
As to claim 24, the presently claimed contents fall within the purview of Guemard’s exemplified masterbatch compositions comprising 80 wt.% PCL and 20 wt.% liquid composition (e.g., Table 2).
As to claim 28, Guemard’s exemplified liquid compositions (LC-B and LC-C) have a PCL content as presently claimed.
Response to Arguments
Applicants’ arguments and amendments filed May 12, 2026 have been fully considered and are persuasive. Therefore, the 35 USC rejection over US 2018/0142097 (Guemard) has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2020/0190279 (Guemard).
As noted hereinabove, Guemard ‘279 discloses mixing an enzyme in the form of an aqueous solution with a polysaccharide in the form of a powder, that is, the enzyme aqueous solution and polysaccharide powder are separately added. Moreover, Guemard ‘279 clearly teaches that the liquid composition, obtained by mixing the enzyme aqueous solution and polysaccharide powder, can be “introduced before the polymer in the extruder” [0192]. Review of the present experimental data of record does not demonstrate criticality for preparing the liquid composition per step (a) in the extruder versus preparing it in an agitating device before introducing it into the extruder as taught by Guemard ‘279. Moreover, Applicants’ argument that the present enzyme aqueous solution is introduced on one side of the mixer and the polysaccharide powder on the other part is not commensurate in scope with present claims, which are not so limited. It is noted that in the present examples, the enzyme aqueous solution is introduced “using a peristaltic pump” while the Arabic gum is introduced “using a metering device”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ana L Woodward whose telephone number is (571)272-1082. The examiner can normally be reached M-F 8am-5pm.
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/ANA L. WOODWARD/Primary Examiner, Art Unit 1765
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