DETAILED ACTION
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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 6 and 17 are objected to because of the following informalities: in each claim, "alpha brain waves" should apparently read --the alpha brain waves--. Appropriate correction is required.
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 6, 7, and 9-20 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.
Claims 6 and 17 recite that “alpha brain waves of the patient increase above 8 Hz during neurofeedback,” while claim 7 recites that “alpha brain waves of the patient increase above 10 Hz during neurofeedback.” It is not clear if these limitations are intended to recite that the frequency of the alpha brain waves increases to above 8 or 10 Hz (e.g., from 7.9 Hz to 8.1 Hz or from 9.5 Hz to 10.5 Hz), or rather that at such frequencies (e.g., at 8.1 Hz or 10.1 Hz) the amplitude increases. Based upon the specification, the latter interpretation has been adopted herein.
Claims 9-11 and 18-20 recite that the formulation has a dosage form of 1500 mg/oz or 3000 mg/oz. It is not clear what is meant by this limitation; e.g., does this mean the concentration of the formulation? If so, is this the concentration of the active ingredient or the triglyceride or something else? If not, is this in relation to the weight of the patient?
Claim 12 recites the limitation "the formulation" in line 5. There is insufficient antecedent basis for this limitation in the claim. This limitation and the “composition” recited in line 2 of the claim are taken herein to be the same thing. It is noted that claims 13 and 18-20 also recite "the formulation" and may need to be amended in kind.
Claims 13-20 are rejected by virtue of their dependence upon claim 12.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 15 recites that the triglyceride comprises a short chain fatty acid. However, this is already recited by claim 12, which claim 15 depends upon. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
Claims 1-8 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (U.S. Pub. No. 2022/0184030 A1), in view of Lowery et al. (U.S. Pub. No. 2020/0129463 A1; hereinafter known as “Lowery”) and Elbogen et al. (U.S. Pub. No. 2021/0361222 A1; hereinafter known as “Elbogen”).
Regarding claim 1, Thompson discloses a method of treating a patient (Abstract), the method comprising: providing a formulation having an active ingredient comprising a cannabinoid acid ([0011]; [0020]; [0029]); delivering the formulation to the patient via a delivery system ([0015]; [0029]); and wherein alpha brain waves of the patient are increased in amplitude ([0028]; [0031]). Thompson fails to disclose that the treating comprises decreasing pain in the patient, that the formulation also comprises a triglyceride and at least 10% of the cannabinoid acid is preserved in its acidic form at a target site, and performing neurofeedback. Lowery discloses a method of decreasing pain in a patient with cannabinoids (Abstract; [0048]) comprising providing a formulation having a triglyceride and a cannabinoid acid in order to improve health ([0005]-[0006]; [0009]; [0035]; [0037]; [0046]-[0048]; [0057]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Thompson by decreasing pain through administering a formulation that includes a triglyceride, as taught by Lowery, in order to improve health of the patient. It is further submitted that this proposed combination would result in at least 10% of the cannabinoid acid being preserved in its acidic form at a target site. The present application does not teach the exact mechanism/formulation that results in such preservation; however, it teaches that the delivery system may be oral administration, that CBDA has much better bioavailability for oral administration, and that short chain fatty acids reduce metabolism/breakdown of the cannabinoid acids, thus increasing bioavailability. The proposed combination also teaches oral administration, the use of CBD acid, and the use of short chain fatty acids.
The combination of Thompson and Lowery fails to disclose performing neurofeedback. Elbogen discloses a method of decreasing pain in a patient (Abstract) comprising performing neurofeedback to increase amplitude/power of alpha brain waves of the patient in order to further treat chronic pain ([0004]-[0007]; [0013]; [0044]; [0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Thompson and Lowery by performing neurofeedback, as taught by Elbogen, in order to further treat chronic pain.
Regarding claim 2, the combination of Thompson, Lowery, and Elbogen discloses the invention as claimed, see rejection supra, and further discloses that the delivery system preferentially transports at least a portion of the formulation to the lymphatic system (e.g., Lowery teaches short chain fatty acids, which are taught by the present invention to achieve this result).
Regarding claim 3, the combination of Thompson, Lowery, and Elbogen discloses the invention as claimed, see rejection supra, and further discloses that the delivery system is selected from oral, buccal, or sublingual (Thompson: [0015], [0029]; Lowery: [0141]).
Regarding claim 4, the combination of Thompson, Lowery, and Elbogen discloses the invention as claimed, see rejection supra, and Lowery further discloses that the triglyceride comprises a short chain fatty acid ([0006]; [0057]).
Regarding claim 5, the combination of Thompson, Lowery, and Elbogen discloses the invention as claimed, see rejection supra, and Elbogen further discloses that the neurofeedback is performed in real-time to provide biofeedback to the patient ([0055]).
Regarding claims 6 and 7, the combination of Thompson, Lowery, and Elbogen discloses the invention as claimed, see rejection supra, and further discloses that alpha brain waves of the patient increase above 8 Hz and 10 Hz during neurofeedback (e.g., Thompson: [0028], [0031]; Elbogen: Fig. 6, [0004]; alpha waves have frequencies above 8 Hz and above 10 Hz, and the proposed combination increases the amplitude of these frequencies).
Regarding claim 8, the combination of Thompson, Lowery, and Elbogen discloses the invention as claimed, see rejection supra, and Lowery further discloses that the cannabinoid acid is CBD (Lowery: [0037]).
Regarding claim 12, Thompson discloses a method of treating a patient (Abstract), the method comprising: providing a composition having an active ingredient comprising a cannabinoid acid ([0011]; [0020]; [0029]); delivering the formulation to the patient via a delivery system ([0015]; [0029]); and wherein alpha brain waves of the patient are increased in amplitude ([0028]; [0031]). Thompson fails to disclose that the treating comprises decreasing chronic pain in the patient, that the composition also comprises a triglyceride comprising a short-chain fatty acid, the cannabinoid acid being selected from CBDA, CBGA, and CBCA, and at least 50% of the cannabinoid acid is preserved in its acidic form at a target site, and performing neurofeedback. Lowery discloses a method of decreasing pain in a patient with cannabinoids (Abstract; [0048]) comprising providing a composition having a triglyceride comprising a short-chain fatty acid and a cannabinoid acid selected from CBDA, CBGA, and CBCA in order to improve health ([0005]-[0006]; [0009]; [0035]; [0037]; [0046]-[0048]; [0057]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Thompson by decreasing pain through administering a composition that includes a triglyceride comprising a short-chain fatty acid and a cannabinoid acid selected from CBDA, CBGA, and CBCA, as taught by Lowery, in order to improve health of the patient. It is further submitted that this proposed combination would result in at least 50% of the cannabinoid acid being preserved in its acidic form at a target site. The present application does not teach the exact mechanism/formulation that results in such preservation; however, it teaches that the delivery system may be oral administration, that CBDA has much better bioavailability for oral administration, and that short chain fatty acids reduce metabolism/breakdown of the cannabinoid acids, thus increasing bioavailability. The proposed combination also teaches oral administration, the use of CBDA, and the use of short chain fatty acids.
The combination of Thompson and Lowery fails to disclose that the pain is chronic pain, as well as performing neurofeedback. Elbogen discloses a method of treating chronic pain in a patient (Abstract) comprising performing neurofeedback to increase amplitude/power of alpha brain waves of the patient in order to treat chronic pain ([0004]-[0007]; [0013]; [0044]; [0056]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Thompson and Lowery by performing neurofeedback, as taught by Elbogen, in order to treat chronic pain.
Regarding claim 13, the combination of Thompson, Lowery, and Elbogen discloses the invention as claimed, see rejection supra, and further discloses that the delivery system preferentially transports at least a portion of the formulation to the lymphatic system (e.g., Lowery teaches short chain fatty acids, which are taught by the present invention to achieve this result).
Regarding claim 14, the combination of Thompson, Lowery, and Elbogen discloses the invention as claimed, see rejection supra, and further discloses that the delivery system is selected from oral, buccal, or sublingual (Thompson: [0015], [0029]; Lowery: [0141]).
Regarding claim 15, the combination of Thompson, Lowery, and Elbogen discloses the invention as claimed, see rejection supra, and Lowery further discloses that the triglyceride comprises a short chain fatty acid ([0006]; [0057]).
Regarding claim 16, the combination of Thompson, Lowery, and Elbogen discloses the invention as claimed, see rejection supra, and Elbogen further discloses that the neurofeedback is performed in real-time to provide biofeedback to the patient ([0055]).
Regarding claim 17, the combination of Thompson, Lowery, and Elbogen discloses the invention as claimed, see rejection supra, and further discloses that alpha brain waves of the patient increase above 8 Hz during neurofeedback (e.g., Thompson: [0028], [0031]; Elbogen: Fig. 6, [0004]; alpha waves have frequencies above 8 Hz, and the proposed combination increases the amplitude of these frequencies).
Claims 9-11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson, Lowery, and Elbogen as applied to claims 8 and 12 above, and further in view of Crumrine (U.S. Pub. No. 2021/0401746 A1). The combination of Thompson, Lowery, and Elbogen discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the formulation has a dosage form of 1500 mg/oz or 3000 mg/oz taken one time per day or of 3000 mg/oz taken four times per day; Lowery does teach that the dosage form may be one time per day or four times per day ([0009]). Crumrine discloses a similar method of treating pain with cannabinoids (Abstract; [0002]-[0004]; [0007]; [0060]; [0171]; [0177]) that have a dosage form of 1500 mg/oz or 3000 mg/oz and can be provided between one time per day to four times per day ([0112]; [0117]; [0136]; 1500 mg/oz is about 50 mg/ml, while 3000 mg/oz is just over 100 mg/ml). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Thompson, Lowery, and Elbogen with the dosage concentrations/frequencies taught by Crumrine as these are known effective dosage forms for treating pain with cannabinoids.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791