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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/21/2026 has been entered.
Claims 1, 3-4 and 6-7 are pending and on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated below are hereby withdrawn.
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Claims 8-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.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 Objections
Claims need to be on its own clean sheet with no other verbiage with the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-4, and 6-7 are 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.
The phrase “generally intact” in claim 1 is a relative term which renders the claim indefinite. The term “generally intact” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. How much or what percentage of protoplasts should be intact for it to be considered “generally intact”?
In Claim 1, the term “from about” is indefinite because “from” indicates a minimum value and “about” indicates a range of values. When the terms “from” and “about” are used together, the term becomes unclear because a minimum value is no longer present. Please amend as appropriate by using either “from” or “about.”
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.
Claim(s) 1, 3-4 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) in view of Kuhn et al. (1981, Methods in Enzymology, 72: 774-783). This is 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.
Kuhn et al. teaches a method of isolating protoplasts from spinach with a mixture of pectinase and cellulase (page 774, paragraph 3) at 30 degree C in a shaking water bath (page 776, paragraph 2) for 4 hours incubation while suspended in mannitol (page 777, paragraph 3).
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. Kuhn et al. teaches a method of isolating protoplasts from spinach with a mixture of pectinase and cellulase (page 774, paragraph 3) at 30 degree C in a shaking water bath (page 776, paragraph 2) for 4 hours incubation (page 777, paragraph 3). “[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 would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to isolate protoplasts from spinach because Kuhn et al. teaches a method of isolating protoplasts from spinach with a mixture of pectinase and cellulase (page 774, paragraph 3) at 30 degree C in a shaking water bath (page 776, paragraph 2) for 4 hours incubation while suspended in mannitol (page 777, paragraph 3). One would have been motivated to use spinach for the expected benefit of isolating protoplasts. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
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. Kuhn et al. teaches a method of isolating protoplasts from spinach with a mixture of pectinase and cellulase (page 774, paragraph 3) at 30 degree C in a shaking water bath (page 776, paragraph 2) for 4 hours incubation while suspended in mannitol (page 777, paragraph 3).
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.
Applicant argues there is hindsight for the use of temperature and time.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Kuhn et al. teaches a method of isolating protoplasts from spinach with a mixture of pectinase and cellulase (page 774, paragraph 3) at 30 degree C in a shaking water bath (page 776, paragraph 2) for 4 hours incubation while suspended in mannitol (page 777, paragraph 3). 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.
Conclusion
No claim is allowed.
Contact Information
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 on Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen
Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
