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 Amendment
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/19/2025 has been entered.
Newly amended Claims 3-7 are pending in the application and examined herein.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Response to Applicant’s Arguments
Applicant argues with respect to the rejection over Carley et al. that Carley fails to provide motivation to select melatonin specifically out of all of the therapeutic agents listed in the same reference. The argument is considered but not persuasive. Carley teaches melatonin as an acceptable therapeutic agent for use with THC (See nonfinal action: Page 7) and the secondary reference Brusco provides further motivation for selecting melatonin as the additional therapeutic to treat the same disease, Alzheimer’s Disease (See Action: Pages 8-9). Applicant emphasizes that Carley “proposes optionally” combining the cannabinoid with melatonin. This proposition only further evidences that the combination of the two claimed ingredients is obvious and expected to be successful for treatment.
Applicant also argues that the claimed combination yields “surprising and unexpected” results. Particularly applicant argues the combination of THC and melatonin do not reduce amyloid precursor protein (APP) as opposed to each API individually (Remarks: Page 8; Specification: Fig 6B and Para 105-119):
PNG
media_image1.png
279
298
media_image1.png
Greyscale
vs
PNG
media_image2.png
323
436
media_image2.png
Greyscale
.
The argument is fully considered but not persuasive. Although applicant demonstrates the first ratio, M1T2, to not significantly reduce APP levels, this is not the case for the second ratio, M2T2, wherein the APP levels are not only not maintained but decreased even lower than those of T2 or T3, and significantly lower than at least that of T2. Applicant’s amended claims embrace ratios wherein the THC content in (mg) is far lower than the M2T2 ratio, which does not exhibit the unexpected results. For example, 14ug of THC to 77 mg of melatonin, as encompassed by Claim 3, yields a mass ratio of 5400:1, whereas the ratio which maintains APP levels, M1T2, is 1:40. M2T2 has 10 times less TCH than M1T2 but still 10 times more than the claimed ratio. The claims encompass ratios at least two orders of magnitude distant from the ratio which yields allegedly unexpected results. Therefore, there is no nexus which connects the unexpected result of M1T2 to the scope of the ranges specified Claim 3, and thus the previously issued rejection over Carley et al. stands.
In response to applicant's argument that the references fail to show certain features of the invention (i.e., the unexpected results described on Remarks, Page 3), it is noted that the feature upon which applicant relies, the ratio not resulting in decreased AβPP, is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant traverses the double patenting rejection over Application no. 17626205 because Cao specifies a composition additionally comprising insulin. Applicant’s argument is considered but not persuasive. Page 8 of the final action directly addresses Applicant’s argument: “Cao further teaches the composition comprises insulin. However, the claim language of the instant claims, ‘comprising’, does not preclude the presence of additional components”; e.g., insulin.
Applicant traverses the double patenting rejection over US Patents no. 11065225 and 114462276 because Cao claims a method rather than a composition. Applicant’s argument is considered but not persuasive. Pages 8-9 of the final action directly address Applicant’s argument: “Cao teaches methods of using such a composition; however, such a method requires the existence of said composition, rendering the composition of the examined claims obvious.”
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.
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.
Claims 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Carley (WO2012068516, published 2012) in view of Brusco (Neuroendocrinology Letters 2000; 21:39–42).
Carley teaches the use of low dose cannabinoids, including organic and synthetic variants of THC like dronabinol (Delta-9-THC) as listed in Claim 6, to treat neurodegenerative diseases including Alzheimer’s Disease (AD) (Title; Page 7, Para 46; Page 8, Para 51-52; Page 4, Para 17; and Page 30, Para 132). The cannabinoids are formed in compositions with additional therapeutics including melatonin (Page 12, Para 72-73). The cannabinoid low dose is taught to range from 0.05-25mg and several exemplary formulations are given in Table 1 wherein the cannabinoid comprises amounts of 0.1, 0.25, 0.5, and 1mg (Page 4, Para 18; Page 21, Table 1). Said values fall within the narrowest range of examined Claims 3-5, 14ug-1.0mg. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 I. Carley does not limit the patient weight to 70kg specifically but also does not preclude the treatment of a patient of such weight.
Carley does not teach specific dosage amounts of melatonin to be combined with the THC of the composition for treating AD.
Brusco teaches formulations of melatonin for the use of treating “chronobiologic and cognitive symptoms” in AD (Title). Specifically “9mg gelatin melatonin capsules” were administered to AD patients and the “results suggest that melatonin can be useful for treatment of Alzheimer’s disease” (Abstract). 9mg falls within both of the melatonin ranges of examined Claims 3 and 7.
Therefore, one of ordinary skill in the art seeking to treat AD would find it obvious to form the composition of THC and melatonin suggested by Carley in view of Brusco and select the dosage amount taught by Brusco to form a composition which is capable of treating AD. One would expect success in doing so as both references alone teach the use of the low dose THC-melatonin composition and the 9mg melatonin capsules for treating AD.
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 3-7 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-4, 21-22, 24, 27, and 30 of copending Application No. 17626205 (hereinafter referred to as Cao).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a composition of low-dose THC, in the form of organic or synthetic TCH, Dronabinol, Delta9-THC, or THC-A, and melatonin.
Cao does not teach the amounts of each component with respect to a 70 kg patient. However, Claim 27 states the THC dose is at least 0.2ug/kg body weight which is 14ug for a 70 kg patient,
0.2
u
g
k
g
*
70
k
g
=
14
u
g
and Claim 30 teaches a melatonin range of 0.11mg/kg to 1.1mg/kg which is 7.7-77mg for a 70kg patient. Claim 21 teaches broader ranges which capture the mg ranges of the instant claims: 25ug-15mg of THC and 1-50mg of melatonin. One of ordinary skill in the art would find it obvious to choose lower values from the ranges of Claim 21 to avoid undesired psychoactive effects or to suit the various dosage forms described in Claims 1-4. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 I.
Cao further teaches the composition comprises insulin. However, the claim language of the instant claims, “comprising”, does not preclude the presence of additional components.
Since both applications teach the combination of THC and melatonin in overlapping amounts, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Cao.
This is a provisional nonstatutory double patenting rejection.
Claims 3-7 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-4 of U.S. Patent No. 11065225 (hereinafter referred to as Cao).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a composition of THC (e.g., organic THC, synthetic THC, Dronabinol, Δ9-THC, and THC-A) and melatonin in overlapping amounts for use in treating Alzheimer’s Disease.
Cao teaches THC and melatonin dose amounts, respectively: 0.2ug/kg-0.02mg/kg and 0.11mg/kg-1.1mg/kg. One of skill in the art, recognizing patients come in varying sizes and weights would convert the above units to mg for a 70kg patient as follows:
1.1
m
g
k
g
*
70
k
g
=
77
m
g
,
yielding respective ranges of THC and melatonin of 14ug-1.4mg and 7.7mg-77mg. The Cao ranges overlap with those of examined Claims 3-5 and 7-9. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 I.
Cao teaches methods of using such a composition; however, such a method requires the existence of said composition, rendering the composition of the examined claims obvious.
Since both claim sets teach a composition of THC and melatonin, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Cao.
Claims 3-7 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-14 of U.S. Patent No. 11446276 (hereinafter referred to as Cao).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a composition of THC (e.g., organic THC, synthetic THC, Dronabinol, Δ9-THC, and THC-A) and melatonin in overlapping amounts for use in treating Alzheimer’s Disease.
Cao teaches THC and melatonin dose amounts, respectively: 0.2ug/kg-0.02mg/kg and 0.11mg/kg-1.1mg/kg. One of skill in the art, recognizing patients come in varying sizes and weights would convert the above units to mg for a 70kg patient as follows:
1.1
m
g
k
g
*
70
k
g
=
77
m
g
,
yielding respective ranges of THC and melatonin of 14ug-1.4mg and 7.7mg-77mg. The Cao ranges overlap with those of examined Claims 3-5 and 7-9. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 I.
Cao teaches methods of using such a composition; however, such a method requires the existence of said composition, rendering the composition of the examined claims obvious.
Since both claim sets teach a composition of THC and melatonin, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Cao.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 7:30am - 4:30pm.
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, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627