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
Claim 1 of J.A. Bobier, US 18/134,772 (04/14/2023) are pending, under examination on merits and rejected.
Drawings
The drawing field on 04/14/2023 is objected to because:
(i). The drawing is not clear enough to be recognized;
(ii). “[W]here only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear” See MPEP 608.02 V (u).
Claim Objections
Claim 1 is objected to amended as the follows:
A method whereby an aqueous solution of carbonic acid is used to extract alkaloids from biomatter comprising:
first adding dried ground biomatter to an extraction tank;
then adding purified water to said extraction tank;
then mixing and agitating said combined dried ground biomatter and said purified water to form a slurry;
then cooling said extraction tank to a temperature just above the freezing point;
then introducing carbon dioxide into said slurry causing the formation of carbonic acid pH of the aqueous mixture to lower to approximately a pH3.5;
then continuing mixing for a prescribed period of extraction time depending on the nature of the biomatter and the alkaloids being extracted and injecting additional CO2 from time to time to maintain the low pH; and,
then once the prescribed period of extraction time has been reached pumping the slurry to a water / solid separator.
Claim Interpretation
Examination requires claim terms first be construed in terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. See, MPEP § 2111. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01. It is also appropriate to look to how the claim term is used in the prior art, which includes prior art patents, published applications, trade publications, and dictionaries. MPEP § 2111.01 (III).
Interpretation of the “Extraction Tank” Clauses
The specification does not define the term of “extraction tank”, based on its plain meaning, the term “extraction tank” is broadly and reasonably interpreted as any container which can be used for an extraction.
Interpretation of the “Whereby” Clauses
There is a “whereby” clause in the preamble of claim 1. The determination of whether a “whereby” clause is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). MPEP 2144.04.I. Herein, the “whereby” clause in the preamble of claim 1 also gives a meaning and purpose to the manipulative steps, therefore, the “whereby” clause is a limitation in the claim.
Interpretation of the Claim Term “Biomatter”
The specification does not provide definition for “Biomatter”, and the closet information disclosed in the specification as:
[0005] The method of this disclosure belongs to the field chemical extractions. More specifically this disclosure addresses a process whereby an aqueous solution of carbonic acid is used to extract alkaloids from biomatter.
Specification at page 1, [0005].
According to the information disclosed by the specification, the term “biomatter” is broadly and reasonably interpreted as any material comprising one or more alkaloid.
Interpretation of the Claim Term “Alkaloids”
The specification does not provide definition for “alkaloids”. The prior art Ji teaches that:
Alkaloids is from the biological world, mainly refers a class of nitrogen-containing organic compounds in the Plantae, most of them have more complex cyclic structure, the nitrogen atom is combined with inside the loop, mostly appears alkaline.
Y. Ji, et al. 6 Journal of Chemical and Pharmaceutical Research 338-345 (2014)(“Ji”) at page 38, introduction.
Therefore, according to the teaching from art, the term “alkaloids” is broadly and reasonably interpreted as any compound has a basic character carrying one or more nitrogen atoms in a ring.
Interpretation of the language of “causing the formation of carbonic acid (H2CO3) which will cause the PH of the aqueous mixture to lower to approximately a PH3.5” and “to maintain the low PH”
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. MPEP § 2111.04 (citing In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005). In the instant case, recitation of the language of
Claim 1 . . . causing the formation of carbonic acid (H2CO3) which will cause the PH of the aqueous mixture to lower to approximately a PH3.5 . . . . to maintain the low PH. . .
does not change any the claimed active steps in the claimed process. The court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Herein, neither the citation of “causing the formation of carbonic acid (H2CO3) which will cause the PH of the aqueous mixture to lower to approximately a PH3.5” nor the citation of “to maintain the low PH” is not a require step, but rather simply expresses the intended result of a process step positively recited, therefore, none of these two citations is not given weight for patentability.
Claim Rejections - 35 USC § 112(a) (Scope of Enablement)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1 is rejected under 35 U.S.C. 112(a) because the specification does not reasonably enable one of skill in the art to make and use the full scope of any alkaloid within the context of claim 1. Factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
MPEP. § 2164.01(a); In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988); In re Wright, 999 F.2d 1557, 27 USPQ2d 1510 (Fed. Cir. 1993).
Breadth of the Claims
The claim is directed to the art of extraction of alkaloids from a biomatter with carbonic acid aqueous solution. The claim is super broad because the species of biomatter and/or alkaloids is unlimited, the claimed biomatter/alkaloids even includes the yet undiscovered biomatter/alkaloids.
State of the Prior Art/Level of Predictability in the Art
This art of extraction of alkaloids with acid aqueous solution is unpredictable. Kopp conducted a preliminary study for extraction of pyrrolizidine alkaloids (PA) from plant with acid aqueous and teaches that:
Considering these results, extracting PAs from a plant matrix is a complex challenge. Based on the matrix, the accompanying compounds, and the structure of PAs, the optimum extraction conditions must be chosen thoroughly. Acidic solvents at high temperatures result in high recoveries for T. farfara and S. officinale, because no or only few PAs with labile functionalities are present in these plant species. PAs in J. vulgaris have to be extracted under more gentle conditions because of labile PAs/PANs occurring in this plant.
T. Kopp, et al, 86(01), Planta Medica 85-90 (2020)(“Kopp”) at page 89, left col., lines 3-11, emphasis added.
Therefore, Kopp teaches one ordinary skilled artisan that extraction pyrrolizidine alkaloids from opium with an acid aqueous is unpredictable.
Guidance in the Specification
The specification does not provide any working example except the drawing Fig. 1. The specification does not provide any guidance on the specific condition for each step of the claimed method, for example, the specification is silent on how to elect a biomatter matrix, how to elect the amount ration between the biomatter and purified water, or how long of treating of the biomatter with carbonic acid aqueous. Regarding the guidance on the time of treating of the biomatter with carbonic acid aqueous, the specification disclosed the information as follows:
[0014] When the PH of the slurry has decreased to near 3.5, mixing continues for a prescribed period of time, depending on the nature of the biomatter and the alkaloids being extracted. If necessary, additional CO2 is injected from time to time to maintain the low PH.
Specification at page 3, [0014].
The Quantity of Experimentation Needed Is Undue
In the current case, claim 1 is properly rejected under 35 U.S.C. § 112(a), for lack of enablement because upon balancing the above-discussed factors, the specification at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full claim scope without undue experimentation.
The primary issue with respect to the § 112 rejection is as follows. The specification does not provide any specific working example nor any specific guidance on the specific condition for each step of the claimed method. This lack of guidance is balanced with the lack of supplemental disclosure in the prior art and the art’s unpredictability.
The amount of experimentation required to properly select a specific biomatter, the suitable amount ration between the biomatter and purified water as well as extraction time so as to meet the claim 1 functional recitations of “to extract alkaloids from biomatter” is necessarily undue on view of the vast breadth of the recited genera of any alkaloids and in view of the lack of guidance in the specification (no specific working example nor guidance) in further view of the unpredictability in the art; for example, Kopp teaches that extracting pyrrolizidine alkaloids from a plant matrix with acid aqueous is a complex challenge, the optimum extraction conditions must be chosen thoroughly. T. Kopp, et al, 86(01), Planta Medica 85-90 (2020)(“Kopp”) at page 89, left col., lines 3-11.
Claim Rejections - 35 USC § 112(b)
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.
Pursuant to 35 U.S.C. 112(b), the claim must apprise one of ordinary skill in the art of its scope so as to provide clear warning to others as to what constitutes infringement. MPEP 2173.02(II); Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention. MPEP § 2173.05(a).
Relative Term
Claim 1 is rejected under 35 U.S.C. 112(b) as indefinite because the term “just” in the claim 1 recitation of “just above the freezing point” is a relative term which renders the claim indefinite. The term “just above” 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. Applicant can overcome this rejection by amending claim 1 to remove the term “just”.
Insufficient Antecedent
Claim 1 is rejected under 35 U.S.C. 112(b) as indefinite because the claim recites the limitation "the freezing point". There is insufficient antecedent basis for this limitation in the claim. Therefore, one ordinary skilled artisan does not know what is the claimed temperature because one ordinary skilled artisan does not know the claimed "the freezing point" refer to which material and different material has different freezing point. Does Applicant intend “the freezing point” to refer to the freezing point of pure water or the freezing point of the slurry? Applicant can overcome this rejection by amending claim 1 to recite “the freezing point of the slurry”.
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 non-obviousness.
Claims 1 is rejected under 35 U.S.C. 103 as being unpatentable over K.G. Tomazi, US20070241065A1 (2007)(“Tomazi”) in view of R. K. Haghi, et al, 66 International Journal of Greenhouse Gas Control, 190-203 (2017)(“Haghi”) and F. Lucile, et al, 57(3) Journal of Chemical & Engineering Data, 784-789 (2012).
The Claim
The claim 1 is schematically summarized by Examiner as follow:
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K.G. Tomazi, US20070241065A1 (2007)(“Tomazi”)
Tomazi teaches a method for extracting at least one alkaloid from opium as follow:
[0054] Experiment III
[0055] The first step was to add 119 grams opium and 300 milliliters deionized (DI) water to a blender. The blender was set to “Liquefy.” Then, slurry was transferred to an Erlenmeyer flask. This was followed by rinsing the blender with two (2) 100 milliliter washes with deionized (DI) water while processing the blender on “Liquefy” for each wash. Both washes were transferred to the Erlenmeyer flask. The pH was adjusted to 3.03 using 125 milliliters of glacial acetic acid. This was stirred overnight at room temperature. This was followed by adding 20 grams of filter aids, then filtered through a 12.5 centimeter Buchner funnel. The filtration was very slow at approximately fifteen (15) minutes per one hundred (100) milliliters of filtrate. Then, fifty (50) milliliters of filtrate and an equal volume of water was added to an Erlemneyer flask. This was followed by adding one hundred (100) milliliters of toluene to the flask. Then one (1) gram of ammonium sulfate was added. The pH was adjusted to 10.0 with 1:2 fifty percent (50%) sodium hydroxide: water (v/v.). This was filtered through a 12.5 centimeter Buchner funnel with WHATMAN® No. 40 filter paper.
Tomazi at page 6, [0054]-[0055], emphasis added.
The Tomazi Experiment III comprises:
(i).adding dry opium which is biomatter to a blender that is a extraction tank;
(ii).adding purified water to said blender;
(iii).mixing and agitating said combined opium and said purified water to form a slurry;
(iv).adjusting pH of the slurry with a acetic acid;
(v).continuing mixing of the slurry for overnight, and
(vi).Transferring the slurry to a water / solid separator.
Per a proposed commercial process, Tomazi teaches that in addition to acetic acid, other weak acid such as carbonic acid can also be used to adjust pH of the a slurry of opium with water. Tomazi at page 11, [0094], line 8. Tomazi also teaches that in the proposed commercial process the filtration can be conducted with a vacuum filter. Tomazi at page 11, [0099].
Therefore, Tomazi fairly teaches one ordinary skilled artisan that acetic acid can be replaced by carbonic acid to adjust pH of the slurry of opium with water; and pumping of the extraction slurry for filtration.
Difference Between Tomazi and Claim 1
Tomazi differs from claim 1 in that:
(i). Tomazi does not teach to add a ground opium to the blender, however, one ordinary skilled artisan is motivated to add a ground opium to the blender so that it can be easily “liquefied” by the blender;
(ii). Tomazi does not teach to cool the slurry before pH adjusting;
(iii). Tomazi does not teach to introducing carbon dioxide into said slurry of the opium with water, however, per a proposed commercial process, Tomazi teaches that in addition to acetic acid, other weak acid such as carbonic acid can also be used to adjust pH of the a slurry of opium with water. Tomazi at page 11, [0094], line 8.
(iv). Tomazi does not teach to injecting additional CO2 from time to time during the period of extraction, however, per the proposed commercial process, Tomazi teaches to check the pH of a slurry of opium with water periodically and add additional weak acid.
R. K. Haghi, et al, 66 International Journal of Greenhouse Gas Control, 190-203 (2017)(“Haghi”)
Haghi teaches that:
Atmospheric concentration of CO2 has increased steadily from around the time of the industrial era. This increase in concentration of CO2 can cause serious global warming and climate change issues. Hence, expanding the methods for removing CO2 from atmosphere has become an important topic.
Haghi at page 190, left col., line 1-5.
Haghi teaches that:
the pH level starts to drop in brine solutions due to CO2 dissolution and formation of carbonic acid in the reservoir as a result of the CO2 injection.
Haghi at page 190, right col. line 3-5. Therefore, Haghi teaches that carbonic acid can be prepared through injection of CO2 into water.
F. Lucile, et al, 57(3) Journal of Chemical & Engineering Data, 784-789 (2012)
Lucile conducted a study of the solubility of CO2 in water and teaches that the solubility of carbon dioxide in pure water increases with increasing pressure and decreases with increasing temperature. Lucile at abstract and page 787, left col. line 1-2 under Figure. 4.
Claim 1 is Obvious
It would have been prima facie obvious for one skilled artisan to arrive at the instantly claimed invention based on the teachings from Tomazi, Haghi and Lucile with a reasonable expectation of success before the effective filing date of the claimed invention.
One ordinary skilled artisan seeking alkaloid from opium (dried at least to the extent that extraneous water is removed) is motivated to modify the Tomazi method by replacing acetic acid with carbonic acid to adjust pH of the slurry of opium with water and pumping the extraction to a water/solid separator for filtration with an expectation of success because Tomazi teaches that acetic acid can be replaced by carbonic acid to adjust pH of the slurry of opium with water; and pumping of the extraction slurry for filtration.
One ordinary skilled artisan is also motivated to modify the proposed method by cooling down the slurry of slurry of opium with water and then injection of CO2 into the slurry. One ordinary skilled artisan has a motivation to do so with a reasonable of success because Haghi teaches that carbonic acid can be prepared through injection of CO2 into water and Lucile teaches that the solubility of carbon dioxide in pure water decreases with increasing temperature.
One ordinary skilled artisan is further motivated to check the pH of a slurry of opium with water periodically and inject CO2 so that can keep the slurry maintain the desired pH value as Tomazi teaches to check the pH of a slurry of opium with water periodically and add additional weak acid. Thus arrive at a method meeting each and every limitation of claim 1, therefore, claim 1 is obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANK S. HOU whose telephone number is (571)272-1802. The examiner can normally be reached 6:30 am-2:30 pm Eastern on Monday to Friday. 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, Scarlett Goon can be reached at (571)2705241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRANK S. HOU/Examiner, Art Unit 1692
/ALEXANDER R PAGANO/Primary Examiner, Art Unit 1692