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 .
DETAILED ACTION
The Amendments filed on July 28, 2025 has been received and entered.
Claims 1-4 and 6-21 are pending. Claims 1-4 and 6-7 are examined on the merits. Claims 8-21 are withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-7), the species spinach, cellulase, erythritol in the reply filed on Aug. 2, 2024 is acknowledged.
Claims 8-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Aug. 2, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Nov. 9, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Claim Rejections - 35 USC § 103
Claim(s) 1-4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Duquenne et al. (2007, Plant Cell Tiss Organ Cult, DOI 10.1007/s11240-007-9226-3). This is not a new rejection.
Duquenne et al. teaches a method of isolating protoplasts from plant tissues by chopping fresh leaves into small pieces and incubating for 1 hour in 0.5 M mannitol, then 6 mL enzymatic mixture containing cellulase dissolved in mannitol (page 2, right column, Protoplast Isolation), which is steps 1 (a) and (d). After the incubation in enzymatic mixture, the suspension was incubated in darkness for 16 h at 23 degree C for PP (protoplasts) of leaves, which is steps (d) and (e). The digest was passed through a 50 mm nylon sieve and the filtrate was centrifuged in a swing-out rotor (100 g, 10 min). The pellet was resuspended in 10 ml flotation medium [0.6 M sucrose, 3 mM MES (morpholino-ethane sulfonic acid), pH 6], which is step (f). Protoplasts were separated from debris by density gradient centrifugation (100 g, 10 min) after gently layering 1ml of rinse medium (0.5 M sorbitol, 10 mM CaCl2, 3 mM MES, pH 6) upon this flotation medium. Floated PP were transferred into a fresh tube and washed with rinse medium to flush out the remaining debris. After centrifugation (100 g, 10 min), the pellet was resuspended in 0.5 M mannitol. The drying the protoplast mixture would occur during centrifugation, which is step (g). The protoplast yield was determined using a Burker counting chamber under visible light (page 3, left column, paragraph 1). The steps without temperature mentioned as in room temperature, which is about 27 degree C. Mannitol is a sugar alcohol, which is an osmotic protectant. Sucrose is an oligosaccharide that enhances the bulk density. The protoplast would be isolated intact because the protoplasts are stained for viability (Fig. 3A), which is step (h).
However, Duquenne et al. does not teach plant material of about 0.1-50% weight, heating to about 30-37 degree C, degrading enzyme for up to 2 hours, spinach.
It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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). (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). see MPEP § 2144.05 part II A. Although the prior art did not specifically disclose the amounts of each constituent, it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of components because concentrations of the claimed components are art-recognized result effective variables because they have the ability for plant material of about 0.1-50% weight, heating to about 30-37 degree C, degrading enzyme for up to 2 hours, which would have been routinely determined and optimized in the pharmaceutical art.
Accordingly, the instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him.
It is obvious to substitute mannitol for erythritol because sugar alcohols are considered obvious to substitute for one another (see MPEP 2144.09). Since isomers are structurally similar, an artisan of ordinary skill would reasonably expect that the isomers would function equivalently to each other. This reasonable expectation of success provides the motivation for the substitution.
It is obvious to substitute one plant leaf for spinach because plant leaves are considered obvious to substitute for one another (see MPEP 2144.09). Since isomers are structurally similar, an artisan of ordinary skill would reasonably expect that the isomers would function equivalently to each other. This reasonable expectation of success provides the motivation for the substitution.
Response to Arguments
Applicant argues that there is no obvious reason to try to optimize the cell wall degradation step.
In response to Applicant’s argument, the claims are drawn toward a method of preparing protoplasts by enzymatic method. Duquenne et al. teaches a method of isolating protoplasts from plant tissues by chopping fresh leaves into small pieces and incubating for 1 hour in 0.5 M mannitol, then 6 mL enzymatic mixture containing cellulase dissolved in mannitol (page 2, right column, Protoplast Isolation). After the incubation in enzymatic mixture, the suspension was incubated in darkness for 16 h at 23 degree C for PP (protoplasts) of leaves. The method of breaking down cell walls by enzymes, such as cellulase if a known method that would depend the amounts of starting plant cell material, the concentration of the cellulase, the pH, the temperature for incubation of the plant cells. The concentrations of the claimed components are art-recognized result effective variables because they have the ability to adjust for plant material of about 0.1-50% weight, heating to about 30-37 degree C, degrading enzyme for up to 2 hours, which would have been routinely determined and optimized in the pharmaceutical art.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655