Reissue Non-Final Office action
Reissue
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Status of Claims
Claims 1-14 and 16-23 are pending. Claims 1-14, 16, and 19 are amended. Claims 17 and 18 are original. Claims 20-23 are new.
Improper Claim Amendments
The claims filed 1, 3-5, 9, 13, and 14 proposed amendments to the claims that do not comply with 37 CFR 1.173(b), which sets forth the manner of making amendments in reissue applications.
In particular claims 1, 3-5, 9, 13, and 14 all indicate omitted matter using strikethrough not the single brackets as required by 37 CFR 1.173(b). Proper correction is required.
Declaration
The reissue oath/declaration filed with this application is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following:
The declaration states that the reissue is broadening but does not identify a single word, phrase, or expression in the specification or in an original claim, and how it renders the original patent wholly or partly inoperative or invalid. Additionally, while the declaration recites that claims 11 and 12 recite series of discontinuous temperatures, while the disclosure supports continuous temperature ranges, the declaration does not indicate how the instant reissue application seeks to broaden the patent. It is noted that broadening a dependent claim does not affect the scope of the patent. See MPEP 1414 II
Claims 1-14 and 16-23 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office action.
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.
Claims 3-5 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 3-5 each recite “which are each at an indicated percentage of that found in a control experiment that is conducted at zero degrees C”. The claims do not recite the particular details of the control experiment. Based on the language of the claims it is unclear what the reaction conditions (such as time, agitation, reagents, amounts) used to produce the control sample are. Additionally, it is noted that the claimed control experiment is not defined in the ‘072 patent. As such, in light of the specification, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of claims 3-5.
For the purpose of examination, a method comprising exposing a cannabis plant material to an ethanolic solvent at the claimed temperature followed by subsequent filtration and evaporation steps will be interpreted as meeting the requirements of claims 3-5. Appropriate action is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5, 11, 12, 16, 17, and 22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ayres, US 2017/0333503 (“Ayres”).
Regarding claim 1, Ayres discloses a method of processing cannabis plant matter to produce a cannabis extract [abstract, 0002, 0012]. The method comprises exposing the cannabis plant matter to an ethanol containing solvent system wherein the solvent system is at a temperature between -25 ˚C and -100 ˚C [0012, 0026, 0028, claim 1]. The disclosed temperature range meets the temperature range limitation recited in claim 1.
Ayres teaches grinding the plant material into a find powder prior to adding to the polar solvent [0039, 0040] which would produce a suspension of plant material in the solvent system. Ayres further teaches that extraction of cannabinoids from the cannabis plant material is complete in about 30 minutes or less [0032, 0033] which corresponds to maintaining said exposing for a predetermined time so as to produce plant matter residue and an extract comprised of said solvent and extract substances. Ayres goes on to teaches separating the plant matter from the solvent system via filtering [0035] which corresponds to the claimed separating said extract from said plant matter residue. Ayres further teaches removing the solvent under vacuum [0035] which corresponds to the claimed drying extract to remove said solvent and any water present, thereby to produce a dried extract.
Regarding claims 3-5, in accordance with the interpretation discussed above when addressing the indefiniteness of claims 3-5, since Ayres teaches a method comprising exposing a cannabis plant material to an ethanolic solvent at the claimed temperature followed by subsequent filtration and evaporation steps, it is reasonably interpreted as meeting the limitation of claims 3-5.
Regarding claims 11, 12, and 21, as is noted above when addressing claim 1, the method of Ayres comprises exposing the cannabis plant matter to a polar solvent wherein the solvent is at a temperature between -25 ˚C and -100 ˚C [0012, 0028] which anticipates the claimed temperature ranges.
Regarding claims 16 and 22, Ayres teaches performing the extraction in a beaker [0039] which reasonably reads on the reservoir and/or bucket recited in claim 16 and the vessel including a bottom recited in claim 22.
Regarding claim 17, Ayres teaches that the disclosed method produces an oil [0040].
Claims 1, 3-7, 10-13, 17-19, and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Finley et al., US 2016/0346339 (“Finley”).
Regarding claim 1, Finley discloses a method extracting oils from cannabis plant material wherein the method comprises exposing cannabis plant material to an ethanolic solvent at a temperature of from about -80 ˚C to about -20 ˚C [abstract, 0054, 0060-0064]. The cannabis plant material may be buds that have been broken into pieces [0060]. The cannabis bud pieces in the ethanolic solvent constitutes a suspension as claimed. After exposing the cannabis plant material to the solvent, the plant material is removed from the solvent by filtering to produce an eluate which is then evaporated (i.e., dried) to remove the solvent [0007-0011, 0054, 0066-0069, 0093, 0094, Fig. 1A]. The temperature range during which the cannabis plant material is exposed to the solvent fall within the temperature range recited in claim 1.
Regarding claims 3-5, in accordance with the interpretation discussed above when addressing the indefiniteness of claims 3-5, since Finley teaches a method comprising exposing a cannabis plant material to an ethanolic solvent at the claimed temperature followed by subsequent filtration and evaporation steps, it is reasonably interpreted as meeting the limitation of claims 3-5.
Regarding claims 6 and 17, Finley teaches that evaporation of the solvent from the eluate leaves an oil [abstract, 0196, 0204].
Regarding claim 7, Finley teaches suspending the cannabis plant material in the ethanolic solvent wherein no additional materials are present [0194] which corresponds to the claimed at least a partial suspension that is entirely a suspension of the cannabis plant material in said solvent.
Regarding claim 10, Finley teaches using 190 proof organic grain wheat spirit as the ethanolic solvent [0064] which reads on the claimed mixture comprising ethanol in a range between less than 100% and about 90% ethanol with the remaining percentage totaling 100% comprising water.
Regarding claims 11, 12, and 21, as is noted above when addressing claim 1, the method of Finley comprises exposing the cannabis plant matter to a polar solvent wherein the solvent is at a temperature between about -80 ˚C to about -20 ˚C [0012, 0028] which anticipates the claimed temperature range.
Regarding claim 13, Finley teaches that the cannabis plant material may consist essentially of buds (i.e., flower) [0060] which reads on the claimed at least 90% flowers. Finley further teaches that the cannabis material may be from a cannabis sativa plant [0056] as claimed.
Regarding claim 18, Finley teaches using the oil produced by the disclosed method in a vaporizer (i.e., a vaping device) [0173].
Regarding claim 19, Finley teaches that the disclosed method produces a composition which may comprise α-humulene [0134].
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 2, 8, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ayres as applied to claim 1 above.
Regarding claim 2, Ayres is silent regarding the temperature at which the filtering step occurs. However, Ayres teaches that it is believed that both the cold temperatures and the solvent system result in waxes and resins not being extracted from cannabis [0030]. Ayres further teaches an example of the disclosed method in which the cannabis extraction step is performed at a temperature of -70 ˚C, the extract containing solvent system is then filtered to produce a filtrate, and the filtrate is subsequently warmed after filtration [0039]. As such, Ayres reasonably teaches or suggests filtering at a cold temperature. In light of Ayre’s teaching it would have been obvious to one of ordinary skill in the art at the time the instant invention was effectively filed to have filtered the extract containing solvent system at the same temperature as the step of exposing the cannabis plant material to the solvent system (i.e., from -25 ˚C to -100 ˚C) in order to (a) avoid the presence of waxes and resins in the final product and (b) avoid having to change temperatures during the process.
Regarding claims 8 and 20, Ayres teaches that extraction of cannabinoids from the cannabis plant material is complete in about 30 minutes or less [0032, 0033] which encompasses, and therefore renders obvious, the claimed range of time (see MPEP 2144.05).
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Finley as applied to claim 1 above.
Regarding claims 8 and 20, Finley teaches incubating the cannabis plant material in the ethanolic solvent for a period of time of from less than 1 minute to 10 minutes [0078] which overlaps, and therefore renders obvious, the claimed range of time.
Claims 9, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Finley as applied to claim 1 above, and further in view of 420 Motoco “How To Make Concentrated Cannabis Oil” https://www.420magazine.com/community /threads/how-to-make-concentrated-cannabis-oil.217727/ and published online on 20 April 2014 (“420 Motoco”)(copy provided herewith).
Regarding claims 9, 22, and 23, as is described above, Finley teaches a method which meets all the limitations of claim 1. Finley teaches that the cannabis plant material may be macerated by mechanical force while soaking in the ethanol solvent [0077]. Finley is silent regarding exposing the cannabis plant material to the solvent in a vessel including a bottom wherein a portion of the plant material is in constant or occasional contact with the bottom of the vessel.
420 Motoco discloses a method of making a cannabis extract comprising a step in which cannabis plant material is exposed to cold ethanol in a vessel comprising a bottom (under “Begin Making Concentrated Cannabis Oil”). 420 Motoco teaches mixing the cannabis plant material and the ethanol by quickly squashing the plant material against the bottom of the vessel with a mixing tool (under “Begin Making Concentrated Cannabis Oil”). The mixture resulting from the squashing of the plant material in the ethanol is subsequently filtered (under “Begin Making Concentrated Cannabis Oil”)
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Figure from 420 Motoco illustrating the disclosed squashing of the plant material.
Finley and 420 Motoco are both directed towards methods of making cannabis extracts using cold ethanol. In light of the teachings of 420 Motoco, it would have been obvious to one of ordinary skill in the art at the time the instant invention was effectively filed to have practiced the method of Finley by exposing the cannabis plant material to the ethanol solvent in a vessel comprising a bottom and squashing the plant material with a mixing tool because it was art recognized to be a suitable method of mixing cannabis plant material with an ethanolic solvent when making cannabis extracts (see MPEP 2144.07). The resulting method would have met the limitations of claim 22 and 23.
Additionally, while modified Finley is silent regarding the ethanolic solvent and plant matter being agitated or shaken for about one minute, one of ordinary skill in the art would have understood that the amount of time for which the squashing taught by 420 Motoco occurs can be increased or decreased depending on how much plant material is being exposed to the ethanolic solvent and/or how much of the plant material is to be exposed to the ethanolic solvent. As such, it would have been obvious to one of ordinary skill in the art at the time the instant invention was effectively filed to have adjusted the time duration of squashing through routine experimentation and thereby arrive at the amount of time recited in claim 9.
Further, one of ordinary skill in the art would readily understand that the squashing taught by 420 Motoco serves the purpose of crushing the plant material in order to allow the ethanolic solvent to extract more of the desired plant compounds. As such, it would have been obvious to one of ordinary skill in the art at the time the instant invention was effectively filed to have initiated squashing of the cannabis plant material immediately after the addition of the ethanolic solvent in order to maximize the extraction time. The resulting method would have had the plant material being squashed less than two minutes after exposure to the ethanolic solvent as recited in claim 9.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 9-12, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-7 of U.S. Patent No. 10,814,249. Although the claims at issue are not identical, they are not patentably distinct from each other because every limitation recited in claims 1, 9-12, and 21 is recited in claims 1 and 4-7 of the reference patent.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10,507,407. Although the claims at issue are not identical, they are not patentably distinct from each other because every limitation recited in claim 1 is recited in claims 1 and 4 of the reference patent.
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 12,157,072 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEE E SANDERSON whose telephone number is (571)270-1079. The examiner can normally be reached M-F: 9:30AM to 7:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEE E SANDERSON/ Reexamination Specialist, Art Unit 3991
Conferees:
/KSO/ Reexamination Specialist, Art Unit 3991
/Patricia L Engle/ SPRS, Art Unit 3991
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