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
Election/Restrictions
Applicant’s election without traverse of cannbidiol as the 5ht1a positive allosteric modulator, alpha-pinene as the 5HT2a negative allosteric modulator, inhaler as the form of administration, cannabidiphorol as the cannabinoid, limonene as the terpene in the reply filed on 12 Aug 2025 is acknowledged.
Claims 1-15 are under consideration to the extent of the elected species, i.e., cannbidiol as the 5ht1a positive allosteric modulator, alpha-pinene as the 5HT2a negative allosteric modulator, inhaler as the form of administration, cannabidiphorol as the cannabinoid, limonene as the terpene.
Priority
The applicant has claimed priority to Application No. 17/667,147 and application No. 63/207,183 on the Applicant Data Sheet.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows: in the prior-filed application, Application No. 63/207,183 and Application No. 17/667,147, the applicant failed to provide adequate written description support for claims 1-15. Accordingly, priority cannot be granted at this time, thus claims 1-15 are granted the filing date of the instant application (02 Apr 2024).
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed applications, Application No. 63/207,183 and Application No. 17/667,147, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Prior applications 63/207,183 and 17/667,147 fail to provide support for a method of treating or reducing symptoms of the ingestion of drug such as cannabis or 5ht2 agonists with the components of the instant claims such as a cannabidiol or a vaccine, antibody or peptide for 5hta or 5ht1 receptors. Accordingly, claims 1-15 are not entitled to the benefit of the prior applications.
Application Data Sheet
The applicant has listed the instant application as a divisional of prior application 17/667,147. However, as noted above, the prior application fails to provide a clear link that supports a method of treating or reducing symptoms of the ingestion of drug such as cannabis or 5ht2 agonists with the components of the instant claims such as a cannabidiol or a vaccine, antibody or peptide for 5hta or 5ht1 receptors as recited in the instant claims. Thus, the instant application discloses and claims subject matter not previously disclosed and while the claimed method is not new matter, the instant case cannot be a Divisional of 17/667,147. A new Application Data Sheet should be filed to update the relationship with case 17/667,147 as a Continuation-In-Part in light of the new subject matter introduced in the instant case relative the parent non-provisional case.
Specification
The abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
The brief description of the figures on page 2 of the specification describes Fig 7 on Page 15. It appears that this was reversed and should be Fig 15 on page 7.
Claim Objections
Claims 1, 4, 7, 11, 14 and 15 are objected to because of the following informalities:
In claims 1 and 14 there is an unnecessary comma between “5ht2a negative” and “allosteric compound.”
Claims 4 and 11 recite “ocosahex-aenoic acid” but this is a misspelling of “docosahexaenoic acid.”
Claims 7, 14 and 15 unnecessarily repeat the phrase “Administering to a human patient a therapeutic amount of” twice.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a process focused on a nature based product without significantly more.
Claim interpretation: Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111.
The claims are directed to a method of treating or reducing symptoms of the ingestion of drugs. The claims provide exemplary drugs such as cannabis and symptoms such as anxiety but the claims are not limited to these. The claims require the administration of compounds such as cannabidiol, alpha-pinene, limonene, butyrate (claims 4 and 11), magnesium and antibodies. Claims 2 and 10 require testing/diagnosing the human patient. The claims further require that the compounds are administered to a human patient with a means such as an inhaler, nebulizer, intravenous, intramuscular, injection, capsule, tablet or pill.
In accordance with the 2019 Revised Patent Subject Mater Eligibility Guidance (aka 2019 PEG), the following analysis is based on the flowchart found in MPEP §2106(III) and is used when considering whether or not a claimed invention recites eligible subject matter.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claims are directed to a process.
Step 2A: Is the claim directed to a judicial exception (i.e. a law of nature, a natural phenomenon (product of nature) or an abstract idea)?
Analysis of Step 2A is divided into two prongs.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon?
This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II), a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
The claims are directed to a process of treating or reducing symptoms of the ingestion of drugs by administering compounds such as cannabidiol, alpha-pinene, limonene, butyrate (claims 4 and 11), magnesium and antibodies which are all natural products.
Since the process is focused on a product which is naturally-occurring, the claim is ‘directed to’ a nature-based product. Since the claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring cannabidiol, alpha-pinene, limonene, butyrate, magnesium and antibodies. There is no indication that the forming the compounds as a composition and the administration process, would change the structure, function or other characteristics of the individual components in any way. Rather, it is expected that any cannabidiol, alpha-pinene, limonene, butyrate, magnesium and antibody component would retain their naturally-occurring structure and function.
Therefore, the claims recite a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d)II.
The claims recite an additional element beyond the natural components such as cannabidiol, alpha-pinene, limonene, butyrate, magnesium and antibodies in that the natural components are administered for the purpose of treating or reducing symptoms of the ingestion of drugs and are administered via a means of inhaler, nebulizer, intravenous, intramuscular, injection, capsule, tablet or pill. The process steps are written at a high level of generality and do not impart any distinct qualities or characteristics to the components and do not associate any particular concentration of a component to a specific symptom or administration method other than requiring the administration of a therapeutic amount. The means of administration (e.g. inhaler or capsule) are also broad standard administration means for administering components to a patient. As shown in the teachings of Hartman (WO 2021/071967), delivering components such as cannabidiol via a means such as an inhaler in an amount resulting in a clinically significant decrease in anxiety (i.e. a symptom of drug ingestion) are all known standard method steps. Similarly, the concept of identifying a patient needing treatment is a standard procedure and the limitation of testing/diagnosing the human patient as in the instant claims is presented in a high level of generality that does not extend beyond what is routine practice, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017). Thus, the process steps of the claims are routine and conventional in the art and do not integrate the product of nature exception into a practical application and the claim is therefore directed to the judicial exception.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As discussed with respect to Step 2A Prong Two, the process steps of the claims are common and readily available to one of ordinary skill in the art and do not result in an alteration of the natural components. Therefore, the claims do not include any additional element which would amount to ‘significantly more’ than the judicial exception itself and thus the claim as a whole does not amount to significantly more than the judicial exception.
Conclusion: The claims which are directed toward a process for treating or reducing symptoms of the ingestion of drugs and are focused on natural products such as cannabidiol, are not markedly different in structure or function as compared to the closest naturally-occurring counterpart. Subsequently, the claims are directed toward a judicial exception under 35 USC 101. Claims 1-15 do not recite any element which would be considered to provide ‘significantly more’ than the judicial exception.
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 1-15 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 1 and 8 are indefinite for the recitation of “the method.” The definite article “the” is understood to refer to a previously recited method, however, claims 1 and 8 are independent. It is unclear if claims 1 and 8 are intended to refer back to a separate method claim.
Claims 1 and 8 are indefinite in the use of “etc” in line 3 of each claim as used in relation to the symptoms resulting from drug ingestion as it is unclear what other types of symptoms are intended to be encompassed by the claims. Claims 2-7, and 9-15 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claims 1 and 8.
Claims 1, 3, 4, 5, 7, 13, 14, 18 and 20 are indefinite in reciting lists of components and leaving the lists open ended with the use of “other.” For example, claim 1 recites allosteric modulators to choose from and ends the list with “or other 5ht1a positive or 5ht2a negative, allosteric compound” and it is unclear if the specified modulators are thus required or not required per the claim. The same indefiniteness is present in the listing of items with the “other phenethylamine,” “other ibogaloid, “other analogs” and “other tryptamine” as it is not clear if the listed components are required or merely exemplary. The same reason for indefiniteness is present in claims 5, 7, 12, 14 and 15 as they recite what appear to be closed groups of components to select from and also leave the groups open ended by reciting “other.” Claims 2-4 and 6 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 1.
Regarding claims 1, 3, 5, 8, 10 and 12, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 2, 4, 6, 7, 9, 11 and 13-15 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claims 1 and 8.
Claims 1, 3, 5, 8, 10 and 12 are indefinite for use of the phrase “but not limited to” as it is unclear what other species are contemplated by the claims. Claims 2, 4, 6, 7, 9, 11 and 13-15 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claims 1 and 8.
Claims 2 and 9 are unclear in the recitation of “5hta” as it is not clear what specific receptor this refers to (e.g. 5ht1a).
Claims 2 and 9 are indefinite in reciting “a vaccine, antibodies or peptides for the 5hta or 5ht1 receptor” for lacking proper antecedent basis. Claims 1 and 8 recite 5ht1 and 5ht2 allosteric modulators but do not recite receptors and it is unclear what “for the 5hta or 5ht1 receptor” in claims 2 and 9 is intended to refer to.
Claims 5 and 12 are indefinite in the use of parenthesis surrounding “non-decarboxylated forms” following “acidic” as it is unclear if what is contained in the parenthesis is intended to be required as a limitation in the claim or if it is merely exemplary.
Claim Rejections - 35 USC § 112
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.
Claims 2-7 and 9-15 are 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.
Base claims 1 and 8 recite methods “consisting of” various administration steps. The transitional phrase "consisting of" excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("consisting of" defined as "closing the claim to the inclusion of materials other than those recited except for impurities ordinarily associated therewith"). Thus, the inclusion of additional steps in the dependent claims fail to further limit the subject matter and broadens the administration steps of the base claims.
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
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.
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, 3, 5, 7, 8, 10, 12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hartman (WO 2021/071967, published 15 Apr 2021, filed 07 Oct 2020) as evidenced by Laprairie et al. (British Journal of Pharmacology (2015) 172 4790–4805).
Regarding the interpretation of the method of treating in the instant claims, the examiner notes that the method is directed to the treatment or reduction of symptoms that may occur from the ingestion of drugs. An example of a symptom that may occur from drug ingestion is anxiety. Thus, the claims are interpreted as a method of treating symptoms such as anxiety.
Hartman teaches a pharmaceutical composition comprising inhalable cannabinoid particles deliverable from a metered dose inhaler ([0003], claim 1), and a method of treating anxiety ([0117], claim 17). Hartman teaches the at least one cannabinoid may be cannabidiol ([0063], claim 1) and also teaches cannabidiphorol (claim 1) rendering obvious the administration of the 5ht1 positive allosteric modulator of claims 1 and 14 and the CBDP of claims 5 and 12. As evidenced by Laprairie, cannabidiol is a negative allosteric modulator of the CB1 receptor (title), and thus the cannabidiol of Hartman renders obvious the administration of CB1 negative allosteric compound of instant claim 8. The inhalable particles administered with an inhaler renders obvious the administration via inhaler. The treatment of anxiety renders obvious the treatment of a symptom of drug ingestion such as anxiety. Hartman additionally teaches the administration of at least one terpene such as limonene ([0065]), rendering obvious claim 7 and 15. Regarding the testing/diagnosing the human patient as in claims 2 and 10, Hartman teaches first identifying a patient having a neurological disorder ([0181]), rendering obvious the diagnosing limitation. The examiner notes that genetic testing and biomarkers are merely exemplary and not require per the claim.
Hartman does not expressly teach selecting cannabidiol, cannabidiphorol and limonene as part of an inhalable composition for treating anxiety with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have administered inhalable particles comprising cannabidiol, cannabidiphorol and limonene with an inhaler for the purpose of treating anxiety. One of ordinary skill in the art would have been motivated to do so as inhalable particle compositions are taught by Hartman as suitable in a method for treating anxiety, and cannabidiol, cannabidiphorol and limonene as known as suitable for such compositions as taught by Hartman. One of ordinary skill in the art would have a reasonable expectation of successfully treating anxiety, which is a symptom of drug ingestion, with cannabidiol, cannabidiphorol and limonene through an inhaler as taught by Hartman since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Hartman.
Claims 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hartman (WO 2021/071967, published 15 Apr 2021, filed 07 Oct 2020) as evidenced by Laprairie et al. (British Journal of Pharmacology (2015) 172 4790–4805) as applied to claims 1, 3, 5, 7, 8, 10, 12, 14 and 15 above and further in view of Wood et al. (US 2013/0150416, published 13 June 2013).
The teachings of Hartman are described supra.
Hartman does not teach administration of a compound such as a metabotropic glutamate receptor allosteric modulator. This deficiency is made up for in the teachings of Wood.
Wood teaches methods of modulating the activity of mGluRs and treating diseases or disorders which as mediated by Group 1 mGluRs comprising contacting the Group I mGluRs with one or more allosteric modulator ([0015]). Wood teaches that compounds of Formula 1 are useful in modulating the functional action of Group 1 metabotropic glutamate receptors ([0041]) and Wood teaches compounds of Formula 1 for treating disorders such as anxiety and anxiety due to a general medical condition ([0057]). Wood teaches the compounds may be administered through inhalation ([0055], [0086]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have further administered a metabotropic glutamate receptor allosteric modulator via inhalation for treating anxiety. Treating anxiety with components such as cannabidiol through an inhaler is obvious from Hartman and allosteric modulators of mGlu receptors, such as the Formula 1 compounds taught by Wood, are known for treating conditions such as anxiety and may be delivered via inhalation, as is taught by Wood. Thus, the administration of an allosteric modulator of mGlu receptors for anxiety would have been obvious since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hartman (WO 2021/071967, published 15 Apr 2021, filed 07 Oct 2020) as evidenced by Laprairie et al. (British Journal of Pharmacology (2015) 172 4790–4805) as applied to claims 1, 3, 5, 7, 8, 10, 12, 14 and 15 above and further in view of Nijhawan (US 2019/0307720, published 10 Oct 2019).
The teachings of Hartman are described supra.
Hartman does not teach the administration of vitamin C. This deficiency is made up for in the teachings of Nijhawan.
Nijhawan teaches a pharmaceutical composition containing cannabis and a medicinal ingredient such as vitamin C for treating stress and or anxiety (abstract). Nijhawan teaches the cannabis may comprise effective amounts of cannabidiol ([0017]). Nijhawan the administration of a therapeutically effective amount of Vitamin C as Vitamin C is an antioxidant involved in anxiety and stress and serves to enhance the treatment of stress and or anxiety ([0051]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have further administered vitamin C as part of the method of treating anxiety rendered obvious from Hartman. Vitamin C is known to be used in cannabis compositions comprising cannabinoid for treating anxiety and stress and vitamin C is known to enhance treatment of anxiety and stress. Thus, it would have been obvious to further administer vitamin C for enhanced treatment of anxiety.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hartman (WO 2021/071967, published 15 Apr 2021, filed 07 Oct 2020) as evidenced by Laprairie et al. (British Journal of Pharmacology (2015) 172 4790–4805) as applied to claims 1, 3, 5, 7, 8, 10, 12, 14 and 15 above and further in view of Antonio et al. (Wo 2018150073A, published 23 Aug 2018).
The teachings of Hartman are described supra.
Hartman does not teach the administration of a peptide for the 5hta or 5ht1 receptor. This deficiency is made up for in the teachings of Antonio.
Antionio teaches that the coadministration of Gal (1-15) and a serotonin reuptake inhibitor produce a significant increase in the synthesis of postsynaptic 5HT1a receptors (page 6 lines 18-20). As indicated by Antonio on page 2 lines 7-8, Gal(1-15) has a peptide formula. Thus, the administration of Gal(1-15) is understood to meet the limitation of administering a peptide for the 5ht1 receptor as recited in claims 2 and 9. Antonio teaches that the use of Gal(1-15) is for treatment of anxiety disorders (page 2 lines 20-21).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have additionally administered Gal(1-15) and a serotonin reuptake inhibitor as part of a method of treating anxiety. The coadministration of Gal (1-15) and a serotonin reuptake inhibitor produce a significant increase in the synthesis of postsynaptic 5HT1a receptors and is taught as suitable for treating anxiety disorder, thus providing one of ordinary skill a reasonable expectation of success in administering Gal(1-15) as part of a method of treating anxiety.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/625,194 in view of Hartman (WO 2021/071967, published 15 Apr 2021, filed 07 Oct 2020).
Claim 1 of the ‘194 application recites a method of reducing symptoms of the ingestion of drugs such as cannabis or 5ht2 agonists such as anxiety. Claim 1 recites administering alpha-pinene and cannabidiol. Claim 2 recites testing/diagnosing. Claim 3 recites administering a metabotropic glutamate receptor allosteric modulator. Claim 4 recites administering CBDP. Claim 5 recites administering magnesium, zinc or vitamin C. Claim 6 recites administering limonene. Claim 7 recites administering a CB1 negative allosteric compound.
The ’194 does not recite a method of administering with an inhaler. This deficiency is made up for in the teachings of Hartman.
The teachings of Hartman are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered the cannabinoid composition with an inhaler as cannabinoids are known to be administered with an inhaler as taught by Hartman. Thus there is a reasonable expectation of success in administering with an inhaler as the administration method is known as suitable for such compounds.
This is a provisional nonstatutory double patenting rejection.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-24 of copending Application No. 18/616,121 in view of Hartman (WO 2021/071967, published 15 Apr 2021, filed 07 Oct 2020), Wood et al. (US 2013/0150416, published 13 June 2013) and Antonio et al. (Wo 2018150073A, published 23 Aug 2018).
Claim 21 of the ‘121 application recites a method of administering components such as alpha-pinene, cannabidiol and limonene for reducing the symptoms of substance abuse. Reducing symptoms of substance abuse renders obvious reducing symptoms of the ingestion of drugs as in the instant claims. Claims 22-24 recite administering magnesium, terpenes and a vaccine or antibodies.
The ’121 does not recite vaccine/antibodies/peptides for 5ht1 receptors, a metabotropic glutamate receptor allosteric modulator, CBDP, testing/diagnosing or administration through an inhaler. These differences are made up for in the teachings of Hartman, Wood and Antonio.
The teachings of Hartman, Wood and Antonio are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered the peptide Gal(1-15), a metabotropic glutamate receptor allosteric modulator and CBDP through inhalation methods such as with an inhaler and to identify patients in need of treatment. The administration of Gal(1-15), metabotropic glutamate receptor allosteric modulators and CBDP are known components for reducing anxiety, which is a symptom arising from drug consumption, as each of these components are known for this purpose, as taught by Hartman, Wood and Antonio. It is further known that cannabinoid formulation may be administered with an inhaler, as taught by Hartman, and it is obvious to identify patients in need of treatment, as taught by Hartman. Thus, the administration of the Gal(1-15), a metabotropic glutamate receptor allosteric modulator and CBDP and the method of inhalation and identifying patients are known and obvious steps in the art for treating patients.
This is a provisional nonstatutory double patenting rejection.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/625,181 in view of Hartman (WO 2021/071967, published 15 Apr 2021, filed 07 Oct 2020) and Antonio et al. (Wo 2018150073A, published 23 Aug 2018).
Claim 1 of the ‘181 application recites a method of treating or reducing symptoms of opiate dependency. Treating symptoms of opiate dependency is understood to meet the limitation of treating symptoms of ingesting drugs. Claim 1 recites the administration of limonene, cannabidiol, magnesium, zinc and alpha-pinene. Claim 2 recites testing/diagnosing. Claim 3 recites administering butyrate as in claims 4 and 11 of the instant claims. Claim 6 recites administering a cannabinoid.
The ’181 application does not recite administration of a peptide for the 5ht1 receptor or CBDP or administration with an inhaler. These deficiencies are made up for in the teachings of Hartman and Antonio.
The teachings of Hartman and Antonio are described supra. Antonio further teaches that Gal(1-15) composition may be used to treat drug abuse (page 2 line 22).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered Gal(1-15), CBDP and to have administered with an inhaler. Gal(1-15) is known to treat anxiety and additionally drug abuse, as taught by Antonio, rendering it obvious to combine with the method of treating opiate dependency. It is further known from Hartman that cannabidiol may be administered with an inhaler, rendering an inhaler administration method as obvious. The ‘181 claims recite administration a cannabinoid and CBDP is a known cannabinoid suitable for treating anxiety and for inhalation providing one with a reasonable expectation of success in administering CBDP with the method of treating opiate dependency.
This is a provisional nonstatutory double patenting rejection.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/625,137 in view of Hartman (WO 2021/071967, published 15 Apr 2021, filed 07 Oct 2020) and Antonio et al. (Wo 2018150073A, published 23 Aug 2018).
Claim 1 of the ‘137 application recites a method of treating symptoms of stimulant use disorder by administering limonene, cannabidiol, magnesium, zinc and alpha-pinene. Claim 2 recites genetic testing/diagnosing. Claim 3 recites administering a metabotropic glutamate receptor allosteric modulator. Claim 6 recites administering a cannabinoid.
The ’137 application does not recite administration of a peptide for the 5ht1 receptor or CBDP or administration with an inhaler. These deficiencies are made up for in the teachings of Hartman and Antonio.
The teachings of Hartman and Antonio are described supra. Antonio further teaches that Gal(1-15) composition may be used to treat drug abuse (page 2 line 22).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered Gal(1-15), CBDP and to have administered with an inhaler. Gal(1-15) is known to treat anxiety and additionally drug abuse, as taught by Antonio, rendering it obvious to combine with the method of treating symptoms of stimulant use disorder. It is further known from Hartman that cannabidiol may be administered with an inhaler, rendering an inhaler administration method as obvious. The ‘137 claims recite administration a cannabinoid and CBDP is a known cannabinoid suitable for treating anxiety and for inhalation providing one with a reasonable expectation of success in administering CBDP with the method of treating symptoms of substance abuse.
This is a provisional nonstatutory double patenting rejection.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/625,131 in view of Hartman (WO 2021/071967, published 15 Apr 2021, filed 07 Oct 2020) and Antonio et al. (Wo 2018150073A, published 23 Aug 2018).
The ‘131 application recites a method of treating symptoms of anxiety by administering limonene, cannabidiol, magnesium, zinc, and alpha-pinene. Claim 2 recites testing/diagnosing and claim 3 recites administering butyrate as in instant claims 4 and 11. Claim 6 recites administering a cannabinoid.
The ’137 application does not recite administration of a peptide for the 5ht1 receptor or CBDP or administration with an inhaler. These deficiencies are made up for in the teachings of Hartman and Antonio.
The teachings of Hartman and Antonio are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered Gal(1-15), CBDP and to have administered with an inhaler. Gal(1-15) is known to treat anxiety, as taught by Antonio, rendering it obvious to combine with the method of treating symptoms of anxiety. It is further known from Hartman that cannabidiol may be administered with an inhaler, rendering an inhaler administration method as obvious. The ‘131 claims recite administration a cannabinoid and CBDP is a known cannabinoid suitable for treating anxiety and for inhalation providing one with a reasonable expectation of success in administering CBDP with the method of treating symptoms of anxiety.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Correspondence
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600