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
Response to Arguments/Affidavit
Applicant's arguments filed in the response have been fully considered but they are not persuasive.
Regarding the applicant’s argument that a reasonable expectation of success has not been shown, the examiner disagrees. Ling discloses the general conditions of the claimed method but does not disclose the claimed type of heating (i.e. tray/shelf heating) or the more specific times and temperatures that the product is held at. Velardi demonstrates successful heating of a product by heating a tray/shelf upon which the product is placed (conduction). Therefore, there is a reasonable expectation of success that the product of Ling could be heated by conduction. Likewise, Sato and Delaveau, teach that modifying time and temperature of treatment is necessary based on the product to adequately dry the product while reducing damage. Therefore, there is an expectation that success is dependent on the selection and modification of time and temperature.
The applicant argues that the claimed method is directed to preserving particular compounds and preserving target weight. The examiner first notes that these are not claimed limitations, but if they were they would be an intended use/result. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the present case, there is reason in the art to modify drying time/temperature even if it may not be for the same stated reasons as the applicant’s.
The remainder of the applicant’s arguments appear to relate to the affidavit and will thus be addressed in the following section.
Regarding the affidavit submitted 9/30/2025:
The affiant presents the argument that a person having ordinary skill in the art would not assume the interchangeability of the product of Ling with a plant product as claimed. The examiner points out that "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. In this case, differences in the product to be dried may require creative steps. The affiant additionally argues that Ling does not disclose a plant part. The examiner disagrees. Ling states “Yanhuning, the chemical name is 14-dehydroxyl - -11, 12-bi-dehydrogenation common andrographis herb lactone, -3, 19-di-potassium dehydroandrographolide succinate sodium salt. from the plant extract of diterpene lactone compound through esterification, dehydration, salt forming method such as structure after modification of dehydroandrographolide succinate sodium potassium salt, is the same substance in vivo active metabolites with potassium” (emphasis added). Ling thus discloses a plant part. The examiner concedes that the plant part of Ling does not appear to enter the dryer as a leaf, stem, or flower. The affiant additionally states that sublimation, based on the current state of the art, is impossible with a complex biological system such as a fully constituted plant or plant part. The examiner points out that previously applied art such as Liu teaches sublimating water from flowers (consequently, the similarity in method of Liu and Ling suggests an interchangeability).
The affiant states that there is a long-felt need and failure of others to freeze-dry terpene containing plants and plant parts. The examiner points out that establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution. The relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors. First, the need must have been a persistent one that was recognized by those of ordinary skill in the art. In re Gershon, 372 F.2d 535, 539, 152 USPQ 602, 605 (CCPA 1967). Additionally long-felt need is analyzed as of the date the problem is identified and articulated, and there is evidence of efforts to solve that problem, not as of the date of the most pertinent prior art references. Texas Instruments Inc. v. Int’l Trade Comm’n, 988 F.2d 1165, 1179, 26 USPQ2d 1018, 1029 (Fed. Cir. 1993). Also, the failure to solve a long-felt need may be due to factors such as lack of interest or lack of appreciation of an invention’s potential or marketability rather than want of technical know-how. Scully Signal Co. v. Electronics Corp. of America, 570 F.2d 355, 196 USPQ 657 (1st. Cir. 1977). In this case, the affiant does not establish a timeline for “long-felt.” The examiner points out that the legality of cannabis use, especially recreational, is relatively recent and not universal. Therefore, the examiner questions the assertion that the applicant’s claims solve a long-felt need. Further, if the timeframe could be considered as satisfying “long-felt,” the failure to satisfy the need may likewise be explained by dubious legality. In other words, those with technical know-how may not have pursued solving the problem for legal reasons or even marketability reasons created by uneven legal status.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-17, 19, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ling (CN 107773540 A), hereinafter Ling, in view of Velardi (US 20100107436 A1), hereinafter Velardi, in view of Sato (US 4612200 A), hereinafter Sato, and further in view of Delaveau (FR 3050262 A1), hereinafter Delaveau, and further in view of Baugh (US 20160245588 A1), hereinafter Baugh.
Regarding claims 1, 6-8, 13-15, and 22, Ling discloses a method of cryo-curing a terpene-containing plant part to obtain a reduced moisture cured terpene-containing plant part (“An Andrographolide Freeze-dried Powder” title. All citations from the machine translation appended to the foreign reference. Andrographolide is a labdane diterpenoid), said method comprising:
a. freezing the terpene-containing plant part for a period of at least about 1 hour at a temperature of less than about -10° F to obtain a frozen plant part (“cooling the temperature of the product to -45 degrees centigrade for 4~5 h, and keeping for 1.5 hours at -45 degrees centigrade”); and
b. curing the frozen terpene containing plant part at a temperature and at a pressure between about 50 millibars and about 0.167 millibars, said curing comprising the steps of:
(i) heating the frozen terpene-containing plant part to an initial temperature for a first time (“a primary sublimation for 80~120 min raising the temperature to -11 degrees centigrade, and keeping for 8~12 hours at -11 degrees centigrade; the vacuum degree is 15~25Pa”);
(ii) heating the terpene-containing plant part to a second temperature of about 10° F to about 40° F for a second amount of time comprising about 30 minutes to about 80 minutes (“secondary subliming: subliming for the first time the temperature of the product after raising the temperature to -6 degrees centigrade, the heating speed is 1 degrees centigrade/min, and keeping for 1~2 hours at -6 degrees centigrade; the vacuum degree is 15~25Pa”);
(iii) heating the terpene-containing plant part to a third temperature of about 40° F to about 60° F for a third time comprising about 2 hours to about 4 hours (“first desorption drying: heating up the temperature of the product to 2 degrees centigrade, the heating speed is 1 degrees centigrade/min, and keeping for 1~2 hours at 2 degrees centigrade; the vacuum degree is 15~25Pa”); and
(iv) heating the terpene-containing plant part to a fourth temperature for a fourth time (“desorption drying for the second time: drying the first desorption of product after heating to 12 degrees centigrade, the heating speed is 1 degrees centigrade/min, and keeping for 1~3 hours at 12 degrees centigrade”),
whereby the frozen terpene-containing plant part is cured under vacuum and obtains the reduced moisture cured turpene-containing plant part, with curing comprising steps (i) to (iv) having time comprising about 8 hours to about 18 and 2/3 hours (“the total time of the drying step is 18~24 hours”); and wherein freezing and curing is performed within a time comprising about 19 and 2/3 hours or about 20 hours to about 36 hours (Add “cooling the temperature of the product to -45 degrees centigrade for 4~5 h, and keeping for 1.5 hours at -45 degrees centigrade” to ” the total time of the drying step is 18~24 hours”).
Ling does not disclose:
said plant part comprising a flower or bud of a cannabis plant;
b. curing the frozen terpene-containing plant part at a temperature maintained below 70° F, said curing comprising the steps of:
(i) heating a surface holding the frozen terpene-containing plant part to an initial temperature of about -5° F to about 5° F for a first time comprising about 30 to about 80 minutes;
(iv) heating the surface to a fourth temperature of about 60° F to less than about 70° F for a fourth time comprising about 8 hours to about 12 hours,
whereby the frozen terpene-containing plant obtains a reduced moisture cured terpene-containing plant part having the moisture content between about 10% to about 12% by weight.
However, Velardi teaches heating a surface holding the product (“A further object is to provide a method and a system for finding in an automated way the optimal process conditions for the main drying phase of a freeze-drying cycle for a product, minimizing the drying time using an optimal heating shelf temperature control strategy arranged for continuously adjusting the temperature of the temperature-controlled shelves through the freeze-drying process” paragraph [0029]).
In view of Velardi’s teachings, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include heating a surface holding the product as is taught in Velardi, in the method disclosed by Ling because Velardi states “accurately controlling a heat flux generated by said temperature-controlled shelves in order to minimize the duration of drying phase and at the same time to maintain the product at a safe temperature level” (paragraph [0038]). Therefore, heating the product of Ling via shelves as in Velardi will reduce drying time and maintain the product at safe temperatures in Ling.
Ling, as modified by Velardi, does not disclose:
said plant part comprising a flower or bud of a cannabis plant;
b. curing the frozen terpene-containing plant part at a temperature maintained below 70° F, said curing comprising the steps of:
(i) heating to an initial temperature of about -5° F to about 5° F for a first time comprising about 30 to about 80 minutes;
(iv) heating to a fourth temperature of about 60° F to less than about 70° F for a fourth time comprising about 8 hours to about 12 hours,
whereby the frozen terpene-containing plant obtains a reduced moisture cured terpene-containing plant part having the moisture content between about 10% to about 12% by weight.
However, it has been held that “[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.” See MPEP §2144.05(II)(A) (quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Although, it has been further held that "[a] particular parameter must first be recognized as a result-effective variable, i.e. a variable which achieves a recognized result, before determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. Refer to MPEP §2144.05(II)(B)(quoting In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In this case, Ling discloses temperatures that are at or near the claimed curing time and temperature values, but does not specifically recite all of the claimed times and temperatures. Achieving the claimed time/temperature values is a results-effective variable. Sato states “To avoid any change of the texture of the fresh meat or the food being dried, the irradiation of the infrared rays onto the meat or other food is stopped when the temperature of the meat or other food is raised to a temperature which is high enough for satisfactory drying but low enough not to cause detrimental effect on the texture of the fresh meat or other food, such as dissolution and denaturing of the protein contained in the meat, which temperature is for instance in the range of +20° C. to +40° C. Termination of the irradiation may be effected by interrupting the power supply to the infrared ray heater. The heating time necessary for achieving the satisfactory drying of the meat varies considerably depending on various factors such as the size of the equipment used for the drying, the distance from the infrared ray heater to the meat, the heating temperature of the infrared ray heater, the kind and thickness of the meat, and the like. In the examples to be described hereinafter, the heating time was about 8-12 hours” column 4, line 9 emphasis added. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify temperatures and times, because the selection of temperatures and times to achieve satisfactory and expedient drying without causing damage constitutes the optimization of design parameters, which fails to distinguish the claim. Furthermore, Delaveau states “Freeze-drying can reduce the moisture content of the product to an extremely low level, between 1% and 10% of the product's density, and prevent bacteria and molds from proliferating and the enzymes from triggering chemical reactions to deteriorate the product” (Citation from the machine translation appended to the foreign reference). Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the target moisture content, because the selection of final moisture content to spoilage and deterioration constitutes the optimization of design parameters, which fails to distinguish the claim.
Ling, as modified by Velardi, Sato, and Delaveau, does not disclose said plant part comprising a flower or bud of a cannabis plant.
However, Baugh teaches said plant part comprising a flower or bud of a cannabis plant (“the devices, components, and methods for a botanical or herb freeze drying system 100 in accordance with the present invention are provided. Embodiments can be employed to modularly freeze dry various botanical items such as, but not limited to, cannabis, tobacco, and a myriad of other herbs or like items/products” paragraph [0022]).
Ling does not disclose cannabis. Baugh teaches cannabis. The substitution of one known element (the plant part of Ling) for another (the cannabis of Baugh) would have been obvious to one having ordinary skill in the art at the time of the invention, since the substitution of cannabis taught in Baugh would have yielded predictable results, namely, a terpene-containing plant product to be dried Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337, 86 USPQ2d 1110 (Fed. Cir. 2008).
Regarding claims 2-5, 11, and 17, Ling, as modified by Velardi, Sato, Delaveau, and Baugh, discloses the method of claim 1.
Ling, as modified by Velardi, Sato, Delaveau, and Baugh,does not disclose:
wherein the initial temperature of step (i) is about 0°F;
wherein the second temperature of step (ii) is about 10°F;
wherein the third temperature of step (iii) is about 50°F;
wherein the curing is performed in about 12 hours;
wherein the freezing and curing is performed in about 20 hours;
wherein the freezing and curing is performed in about 36 hours.
However, it has been held that “[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.” See MPEP §2144.05(II)(A) (quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Although, it has been further held that "[a] particular parameter must first be recognized as a result-effective variable, i.e. a variable which achieves a recognized result, before determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. Refer to MPEP §2144.05(II)(B)(quoting In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In this case, Ling discloses temperatures that are at or near the claimed curing time and temperature values, but does not specifically recite all of the claimed times and temperatures. Achieving the claimed time/temperature values is a results-effective variable. Sato states “To avoid any change of the texture of the fresh meat or the food being dried, the irradiation of the infrared rays onto the meat or other food is stopped when the temperature of the meat or other food is raised to a temperature which is high enough for satisfactory drying but low enough not to cause detrimental effect on the texture of the fresh meat or other food, such as dissolution and denaturing of the protein contained in the meat, which temperature is for instance in the range of +20° C. to +40° C. Termination of the irradiation may be effected by interrupting the power supply to the infrared ray heater. The heating time necessary for achieving the satisfactory drying of the meat varies considerably depending on various factors such as the size of the equipment used for the drying, the distance from the infrared ray heater to the meat, the heating temperature of the infrared ray heater, the kind and thickness of the meat, and the like. In the examples to be described hereinafter, the heating time was about 8-12 hours” column 4, line 9 emphasis added. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify temperatures and times, because the selection of temperatures and times to achieve satisfactory and expedient drying without causing damage constitutes the optimization of design parameters, which fails to distinguish the claim.
Regarding claims 9 and 10, Ling, as modified by Velardi, Sato, Delaveau, and Baugh,discloses the method of claim 1.
Ling, as modified by Velardi, Sato, Delaveau, and Baugh, does not explicitly disclose wherein the cryo-cured plant has a terpene content of about 0.5% to about 4% by weight. However, it has been held that “[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.” See MPEP §2144.05(II)(A) (quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Although, it has been further held that "[a] particular parameter must first be recognized as a result-effective variable, i.e. a variable which achieves a recognized result, before determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. Refer to MPEP §2144.05(II)(B)(quoting In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In this case, Ling discloses “The invention claims a traditional Chinese medicine preparation technology field, specifically claims a dehydroandroandrographolide succinate freeze-dried powder and preparation method thereof” (The examiner again points out Andrographolide is a labdane diterpenoid). Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the terpene content, because the selection of terpene content (as an active medicinal ingredient) constitutes the optimization of design parameters, which fails to distinguish the claim.
Regarding claim 12, Ling, as modified by Velardi, Sato, Delaveau, and Baugh, discloses the method of claim 1, wherein the freezing and curing is performed in about 24 to about 36 hours (Add “cooling the temperature of the product to -45 degrees centigrade for 4~5 h, and keeping for 1.5 hours at -45 degrees centigrade” to ” the total time of the drying step is 18~24 hours”).
Regarding claim 16, Ling, as modified by Velardi, Sato, Delaveau, and Baugh, discloses the method of claim 1, wherein the freezing and curing is performed in about 24 hours (Add “cooling the temperature of the product to -45 degrees centigrade for 4~5 h, and keeping for 1.5 hours at -45 degrees centigrade” to ” the total time of the drying step is 18~24 hours”).
Regarding claim 19, Ling, as modified by Velardi, Sato, Delaveau, and Baugh, discloses the method of claim 1, wherein the freezing and curing is performed in about less than 24 hours (Add “cooling the temperature of the product to -45 degrees centigrade for 4~5 h, and keeping for 1.5 hours at -45 degrees centigrade” to ” the total time of the drying step is 18~24 hours”).
Regarding claim 20, Ling, as modified by Velardi, Sato, Delaveau, and Baugh, discloses the method of claim 1, wherein the freezing and curing is performed in about 20 hours to about 36 hours (Add “cooling the temperature of the product to -45 degrees centigrade for 4~5 h, and keeping for 1.5 hours at -45 degrees centigrade” to ” the total time of the drying step is 18~24 hours”).
Claims 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ling, in view of Velardi, in view of Sato, in view of Delaveau, in view of Baugh, and further in view of Zhang (CN 107751354 A), hereinafter Zhang.
Regarding claims 18 and 21, Ling, as modified by Velardi, Sato, Delaveau, and Baugh, discloses the method of claim 1, wherein freezing is performed for a period at a temperature (“cooling the temperature of the product to -45 degrees centigrade for 4~5 h, and keeping for 1.5 hours at -45 degrees centigrade”).
Ling, as modified by Velardi, Sato, Delaveau, and Baugh, does not disclose a period comprising about 8 hours at a temperature of about -40°F to about -20°F.
However, Zhang teaches a period comprising about 8 hours at a temperature of about -40°F to about -20°F (“-15 to -30 degrees centigrade, freezing for 4-8 hours, freezing” all citations from the machine translation appended to the foreign reference).
Ling discloses a lower freezing time for a shorter period than claimed. Zhang teaches the claimed higher temperature for a longer period. The substitution of one known (the low temp/short time freeze of Ling) for another (the high temp/long time freeze) would have been obvious to one having ordinary skill in the art at the time of the invention, since the substitution of the high temp/long time freeze taught in Zhang would have yielded predictable results, namely, freezing a product in preparation for freeze drying Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337, 86 USPQ2d 1110 (Fed. Cir. 2008).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Ling, in view of Velardi, in view of Sato, in view of Delaveau, in view of Baugh, and further in view of Corver (US 20140215845 A1), hereinafter Corver.
Regarding claim 23, Ling, as modified by Velardi, Sato, Delaveau, and Baugh, discloses the method of claim 1, wherein step (iv) comprises heating the surface at ramp rate such that a temperature of the surface increases (“desorption drying for the second time: drying the first desorption of product after heating to 12 degrees centigrade, the heating speed is 1 degrees centigrade/min, and keeping for 1~3 hours at 12 degrees centigrade” emphasis added).
Ling, as modified by Velardi, Sato, Delaveau, and Baugh, does not disclose wherein step (iv) comprises heating the surface at ramp rate such that a temperature of the surface increases over the full time period.
However, Corver teaches a slow ramp rate (“Amorphous compositions may require that the temperature increase from primary to secondary drying be controlled at a slow ramp rate to avoid collapse” paragraph [0008]).
In view of Corver’s teachings, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include a slower ramp rate as is taught in Corver, in the method disclosed by Ling because Corver states that a slow ramp rate avoids collapse. Therefore, extending the ramp rate for the duration of the drying step will improve the dried product of Ling.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Hernandez (US 3376652 A) “Thus, there remains for consideration the system of heat transfer employing the direct conduction method. As used hereinafter, the term "conduction" is meant in a direct sense and is not to be confused with those elements of indirect conduction resulting from the use of infrared radiant or microwave radiant heat wherein the application of heat to an ice front may occur by conduction via an already partially or even completely dried portion of the product” column 3, line 66
Musher (US 2278472 A) “The Pressure also may be considerably varied, as, for example, from about 30 or 40 pounds per 65 square inch to 200 to 300 pounds per square inch, although the pressure, temperature, length of time involved, and other conditions may be adjusted to whatever amounts and conditions are necessary to produce the desired results, and depending upon the characteristics of the products treated” page 4, column 2, line 63
Rey (US 3078586 A) “The efficiency and production rate of the apparatus are both increased because the operating temperature is at all times maintained at a value very closely approximating the desirable optimum, positively averting the danger of thawing and resulting damage to the substance while at the same time maintaining the fastest operating rate consistent with safety” column 3, line 59
Dhanaraj (US 20150258142 A1) “The temperature was then ramped to a shelf temperature of minus five (5) degrees Celsius and held for 2 hours with vacuum set to 50 mT. The temperature was then ramped to a shelf temperature of zero (0) degrees Celsius and held for 90 minutes with vacuum set to 50 mT. The temperature was then ramped to a shelf temperature of ten (10) degrees Celsius and held for 90 minutes with vacuum set to 50 mT. The temperature was then ramped to a shelf temperature of twenty (20) degrees Celsius and held for 60 minutes with vacuum set to 50 mT” paragraph [0046]
Ho (US 20060051731 A1) “One example of a suitable lyophilization protocol includes freezing the lyophilization composition at -45.degree. C. for 2 hours, maintaining the frozen composition at - 40.degree. C. for 150 minutes at a vacuum of about 100 mTorr, and slowly raising the temperature, in 10.degree. C. increments, to 25.degree. C. (at about 100 mTorr vacuum) over a six hour period. Another example of a suitable lyophilization protocol includes freezing the lyophilization composition at -45.degree. C. for about 4.5 hours, maintaining the frozen composition at -45.degree. C. to -40.degree. C. for one hour under a vacuum of 100 mTorr, and slowly raising the temperature, in 10 degree steps, to 30C over a 24 hour period at 100 mTorr vacuum”
Vehring (US 20100297231 A1) “In a preferred embodiment of secondary drying of microorganisms, the drying temperature is slowly raised from primary drying conditions in a slowly and continuously (e.g., with a temperature gradient profile) or in a series of small steps”
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/LOGAN P JONES/Examiner, Art Unit 3762 /MICHAEL G HOANG/Supervisory Patent Examiner, Art Unit 3762