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 .
Formal Matters
Claims 1-19 are pending and under examination.
Priority
This application is a CIP of 17/191,996, filed 03/04/2021, which claims benefit to PRO 63/100,221, filed 03/04/2020.
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:
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 application, Application No. 17/191,996, fails 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. The amounts of PEA, DHA, and BCP recited in at least independent claims 1 and 14 are not supported by the ‘996 application. The ‘996 application discloses doses not exceeding about 1200 mg/day of the palmitoylethanolamide (PEA), not exceeding about 0.1mL/kg of beta-caryophyllene (BCP), and not exceeding about 10 mg/kg of docosahexaenoic acid (DHA); wherein the pharmaceutical daily dosage form has palmitoylethanolamide in a weight percentage between about 1 and about 2%, beta-caryophyllene (BCP) in a weight percentage between about 10 and about 30% and docosahexaenoic acid (DHA) in a weight percentage between about 10 and about 30%. The instant claims literally encompass embodiments falling outside the doses and/or weight percentage ranges described in the ‘996 application. The new matter added to the present Continuation-in-Part application is clearly evidenced by comparing the “daily dose range” of PEA, beta-caryophyllene, and DHA taught in Table 1 from each respective application.
‘996 Application
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Present Application
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The earliest effective filing date afforded the claimed invention is 06/23/2023 – the filing date of the instant application.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed 06/26/2023 has been received and entered into the present application. As reflected by the attached, completed copies of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
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.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 1-13 and 17-19
Claims 1-13 and 17-19 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.
Claim 1 recites a method of helping to replenish levels of endogenous palmitoylethanolamide (PEA) and docosahexaenoic acid (DHA), restoring their protective, anti-inflammatory, and analgesic effects, and protecting the health of a mammal in need thereof. Following the transitional phrase “comprising”, the claim recites “a synergistic supplemental daily dosage form containing exogenous palmitoylethanolamide (PEA) in an ultra-micronized form, docosahexaenoic acid (DHA) and beta-caryophyllene (BCP); wherein palmitoylethanolamide (PEA) is contained in an amount between 25mg and 1200mg per dosage, preferably 50mg to 1000mg, and more preferably 50mg to 600mg, and not exceeding 3600mg per dose; wherein beta-caryophyllene (BCP) is contained in an amount between 10mg and 500mg per dosage, preferably 15mg to 300mg, and more preferably 20mg to 150mg, and not exceeding 750mg mg per dose; wherein docosahexaenoic acid (DHA) is contained in an amount between 0.5mg and 250mg per dosage, preferably 1mg to 100mg, and more preferably 5mg to 50mg, and not exceeding 300mg per dose; wherein the supplemental daily dosage form has palmitoylethanolamide in a weight percentage between about 2 and about 85%, preferably between 5 and 30%, and more preferably between 7 and 15%, beta-caryophyllene (BCP) in a weight percentage between about 0.1 and about 20%, preferably between 2 and 11%, and more preferably between 5 and 7.5%, and docosahexaenoic acid (DHA) in a weight percentage between about 0.001 and about 15%, preferably between 0.01 and 5%, and more preferably between 0.01 and 2.5%”.
It is entirely unclear what Applicants are claiming because no actual method/process steps are recited in the claim. The claims are incomplete and therefore indefinite under 35 U.S.C. 112(b) because a “method” requires that actual process/methods are performed. Here, while reciting “[a] method of helping to replenish levels of endogenous palmitoylethanolamide (PEA) and docosahexaenoic acid (DHA), restoring their protective, anti-inflammatory, and analgesic effects, and protecting the health of a mammal in need thereof”, the claim 1 does not actually recite administering anything to any subject.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitations “palmitoylethanolamide (PEA) is contained in an amount between 25mg and 1200mg per dosage”, “beta-caryophyllene (BCP) is contained in an amount between 10mg and 500mg per dosage”, “docosahexaenoic acid (DHA) is contained in an amount between 0.5mg and 250mg per dosage”, “palmitoylethanolamide in a weight percentage between about 2 and about 85%”, “beta-caryophyllene (BCP) in a weight percentage between about 0.1 and about 20%”, and “docosahexaenoic acid (DHA) in a weight percentage between about 0.001 and about 15%”, and the claim also recites “preferably 50mg to 1000mg, and more preferably 50mg to 600mg, and not exceeding 3600mg per dose” (for the amount of palmitoylethanolamide), “preferably 15mg to 300mg, and more preferably 20mg to 150mg, and not exceeding 750mg mg per dose” (for the amount of beta-caryophyllene), “preferably 1mg to 100mg, and more preferably 5mg to 50mg, and not exceeding 300mg per dose” (for the amount of DHA), “preferably between 5 and 30%, and more preferably between 7 and 15%” (for the weight percentage of palmitoylethanolamide), “preferably between 2 and 11%, and more preferably between 5 and 7.5%” (for the weight percentage of beta-caryophyllene), and “preferably between 0.01 and 5%, and more preferably between 0.01 and 2.5%” (for the weight percentage of DHA), which are narrower statements of the ranges/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The claims are therefore additionally unclear because the recited “preferably” and “more preferably” claim language renders the claims unclear whether the amounts and/or weight percentages following “preferably” and “more preferably” are claim limitations, i.e., whether the claims are intended to be limited to the preferable or more preferable amounts and/or weight percentages.
Finally, it is unclear what distinction is intended between “daily dosage form”, “dosage”, and “dose” in the claims. For example, the claim recites the “daily dosage form” contains PEA in an amount between 25mg and 1200mg per dosage, preferably 50mg to 1000mg, and more preferably 50mg to 600mg, but also recites the amount of PEA does not exceed 3600mg per dose, which is outside the claimed “between 25mg and 1200mg per dosage”.
Claim 2
Claim 2 is 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.
Claim 2 recites the pharmaceutical daily dosage form is an oral, rectal, topical, or transdermal dosage form, comprising one or more of cream, lotion, balm, or ointment. It is unclear if all of the oral, rectal, topical, or transdermal dosage forms are required to be one or more of cream, lotion, balm, or ointment or if this limitation is intended only for the transdermal dosage form.
Claim 9
Claim 9 is 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.
Claim 9 recites the limitations “…an active dosage not exceeding 0.1mL/kg of beta-caryophyllene (BCP)…” and “…docosahexanoic acid (DHA)…but not exceeding about 10 mg/kg…”. It is entirely unclear what weight “kg” is referring to, e.g., total weight of the dosage form, weight of an undefined subject, etc.
Claim 11
Claim 11 is 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.
Claim 11 recites the limitation "…wherein the neuropathic pain results from a disease selected from the group consisting of…" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 11 depends from claim 1, which does not recite anywhere in the claim “neuropathic pain”. As such, it is unclear what neuropathic pain claim 11 is referring to.
Claims 14-16
Claims 14-16 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites the broad recitations “palmitoylethanolamide (PEA) in a weight percentage between about 5 and about 100%”, “beta-caryophyllene (BCP) in a weight percentage between about 1 and about 10%”, and “docosahexaenoic acid (DHA) in a weight percentage between about 0.001 and about 2.5%”, and the claim also recites “preferably between 5 and 15%, and more preferably between 5 and 10%” (for the weight percentage of palmitoylethanolamide), “more preferably between about 2.5 and 7.5%, and more preferably between 5 and 7.5%” (for the weight percentage of beta-caryophyllene), and “more preferably between 0.01 and 2% (for the weight percentage of DHA), which are narrower statements of the ranges/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The claims are therefore unclear because the recited “preferably” and “more preferably” claim language renders the claims unclear whether the weight percentages following “preferably” and “more preferably” are claim limitations, i.e., whether the claims are intended to be limited to the preferable or more preferable weight percentages.
Claim Rejections - 35 USC § 112(d)
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 12 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 12 depends directly from claim 1 and recites that the supplemental dosage daily dosage form “is for human or veterinary use”. This intended use of the supplemental dosage daily dosage form recited in claim 1 does not place any further limitations on the supplemental dosage daily dosage form recited in claim 1. Furthermore, because claim 1 recites “a mammal in need thereof”, the supplemental dosage daily dosage form recited in claim 1 is already inherently intended for human or veterinary use.
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.
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,684,600.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by and/or rendered prima facie obvious by the ‘600 patent claims.
Regarding instant claims 1, 9, and 14, the ‘600 patent recites a synergistic pharmaceutical daily dosage form comprising: between about 1 and about 2% by weight of palmitoylethanolamide (PEA) in an ultramicronized form, between about 10 and about 30% by weight of beta-caryophyllene (BCP) and between about 10 and about 30% by weight of docosahexaenoic acid (DHA) in liquid form; wherein a daily dose of the palmitoylethanolamide (PEA) does not exceed about 1200 mg/day, a daily dose of the beta-caryophyllene (BCP) does not exceed about 0.1 mL/kg per kg body weight of the mammal, and a daily dose of the docosahexaenoic acid (DHA) does not exceed about 10 mg/kg per kg body weight of the mammal (‘600 patent claim 1) and s method of treating neuropathic and inflammatory pain in a mammal, comprising: administering to a mammal in need thereof a dosage form selected from the group consisting of a chew, tablet, capsule, or a liquid form of a synergistic pharmaceutical composition, wherein each dosage form of the pharmaceutical composition comprises: palmitoylethanolamide (PEA) in a weight percentage between about 1 and about 2%, beta-caryophyllene (BCP) in a weight percentage between about 10 and about 30% and docosahexaenoic acid (DHA) in a weight percentage between about 10 and about 30% and one or more compounds with anti-inflammatory activity in a total weight percentage ranging between 0 and about 20% (‘600 patent claim 13).
Regarding instant claims 2, 9, and 17-18, the ‘600 patent recites the pharmaceutical daily dosage form is an oral or topical dosage form (‘600 patent claim 2), in the form of a tablet, a capsule, or liquid (‘600 patent claim 9), and/or a topical dosage form selected from the group consisting of a transdermal patch, a cream, a lotion, an ointment, and a powder (‘600 patent claims 16-17).
Regarding instant claims 3-4 and 6-8, the ‘600 patent recites the pharmaceutical daily dosage form further comprises one or more compounds with anti-inflammatory activity in a total weight percentage ranging between 0 and about 20% (‘600 patent claim 3), the one or more compounds with anti-inflammatory activity is selected from the group consisting of plant derived terpenes/terpenoids, polyphenols, B vitamins, and combinations thereof (‘600 patent claim 4), the one or more compounds with anti-inflammatory activity, comprises a terpene comprising one or more of beta-carophyllene and humulene (‘600 patent claim 5), the one or more compounds with anti-inflammatory activity is one or more polyphenols (‘600 patent claim 6), the one or more compounds with anti-inflammatory activity comprises a polyphenol selected from the group consisting of Flavonoids, Polyphenolic amides, curcumin, and combinations thereof (‘600 patent claim 7), and the one or more compounds with anti-inflammatory activity are quercetin, a capsaicinoid, and curcumin (‘600 patent claim 8).
Regarding instant claim 10, the ‘600 patent recites the one or more compounds with the anti-inflammatory activity is comicronized with the palmitoylethanolamide (‘600 patent claim 10).
Regarding instant claim 11, the ‘600 patent recites the neuropathic pain results from the same Markush group listing of diseases (‘600 patent claim 11).
Regarding instant claim 13, the ‘600 patent recites the palmitoylethanolamide is in ultra-micronized form (um PEA) with a particle size ranging between about 0.8 and about 6 microns (‘600 patent claim 12).
Regarding instant claim 15, the ‘600 patent recites the palmitoylethanolamide is in non-micronized form with a particle size ranging between about 50 and about 100 μm, in micronized form (mPEA) with a particle size ranging between about 2 and about 10 μm, or in ultra-micronized form (umPEA) with a particle size ranging between about 0.8 and about 6 μm, or in a mixture of such forms (‘600 patent claim 14).
Regarding instant claim 16, the ‘600 patent recites said beta-caryophyllene (BCP) and docosahexaenoic acid is in a miscible form (‘600 patent claim 15).
Regarding instant claim 19, the ‘600 patent recites the pharmaceutical daily dosage form further comprises one or more of cannabigerol (CBG), cannabidiol (CBD) and cannabidiolic acid (CBDA) (‘600 patent claim 18).
Accordingly, all of the limitations of the instant claims are expressly recited in the ‘600 patent claims or fall squarely within the scope of the ‘600 patent claims.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2021/0275485 A1 (Published Sept. 9, 2021)1.
US ‘485 teaches a method of treating inflammatory and neuropathic pain in a mammal comprising: administering to a mammal in need thereof a synergistic pharmaceutical daily dosage form comprising: palmitoylethanolamide (PEA) in an ultramicronized form, beta-caryophyllene (BCP) and docosahexaenoic acid (DHA) in liquid form; wherein the palmitoylethanolamide (PEA), beta-caryophyllene (BCP) and docosahexaenoic acid (DHA) are contained in the daily dosage form in doses not exceeding about 1200 mg/day of the palmitoylethanolamide (PEA), not exceeding about 0.1 mL/kg of beta-caryophyllene (BCP), and not exceeding about 10 mg/kg of docosahexaenoic acid (DHA); wherein the pharmaceutical daily dosage form has palmitoylethanolamide in a weight percentage between about 1 and about 2%, beta-caryophyllene (BCP) in a weight percentage between about 10 and about 30% and docosahexaenoic acid (DHA) in a weight percentage between about 10 and about 30% ([0017]-[0020]; Claim 1). It also teaches a method of treating neuropathic and inflammatory pain in a mammal, comprising: administering to a mammal in need thereof a dosage form selected from the group consisting of a chew, tablet, capsule, or a liquid form of a synergistic pharmaceutical composition, wherein each dosage form of the pharmaceutical composition comprises: palmitoylethanolamide in a weight percentage between about 1 and about 2%, beta-caryophyllene (BCP) in a weight percentage between about 10 and about 30% and docosahexaenoic acid (DHA) in a weight percentage between about 10 and about 30% and one or more compounds with anti-inflammatory activity in a total weight percentage ranging between 0 and about 20% ([0021]; Claim 14). The daily dose range of PEA is 100-1200 mg, the daily dose range of beta-caryophyllene is 0.01-0.1 mL/kg, and the daily dose range of DHA is 1.0-10 mg/kg (Table 1). Specifically, regarding claims 1, 3-7, 9, and 14, a supplement is taught comprising:
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(Table 1). Regarding claims 2 and 17-18, it teaches the present compositions can be administered as a daily dosage form that is an oral or topical dosage form. Non-limiting examples of topical dosage forms useful herein include liquids, creams, gels, ointments, foam, solutions, suspensions, lotions, and the like. Non-limiting examples of oral dosage forms useful herein include tables, capsules, liquids, and the like ([0069]; Claims 2 and 17-18). Regarding claims 3-4 and 6-8, the it teaches the pharmaceutical daily dosage form further comprises one or more compounds with anti-inflammatory activity in a total weight percentage ranging between 0 and about 20% (Claim 3), the one or more compounds with anti-inflammatory activity is selected from the group consisting of plant derived terpenes/terpenoids, polyphenols, B vitamins, and combinations thereof (Claim 4), the one or more compounds with anti-inflammatory activity, comprises a terpene comprising one or more of beta-carophyllene and humulene (Claim 5), the one or more compounds with anti-inflammatory activity is one or more polyphenols (Claim 6), the one or more compounds with anti-inflammatory activity comprises a polyphenol selected from the group consisting of Flavonoids, Polyphenolic amides, curcumin, and combinations thereof (Claim 7), and the one or more compounds with anti-inflammatory activity are quercetin, a capsaicinoid, and curcumin (Claim 8). Regarding claim 10, the it teaches the one or more compounds with the anti-inflammatory activity is comicronized with the palmitoylethanolamide (Claim 10). Regarding claim 11, it teaches the neuropathic pain results from the same Markush group listing of diseases (Claim 11). Regarding claim 13, it teaches the palmitoylethanolamide is in ultra-micronized form (um PEA) with a particle size ranging between about 0.8 and about 6 microns (Claim 13). Regarding claim 15, it teaches the palmitoylethanolamide is in non-micronized form with a particle size ranging between about 50 and about 100 μm, in micronized form (mPEA) with a particle size ranging between about 2 and about 10 μm, or in ultra-micronized form (umPEA) with a particle size ranging between about 0.8 and about 6 μm, or in a mixture of such forms (Claim 15). Regarding claim 16, it teaches said beta-caryophyllene (BCP) and docosahexaenoic acid is in a miscible form (Claim 16). Regarding claim 19, it teaches the pharmaceutical daily dosage form further comprises one or more of cannabidiol (CBD) and cannabidiolic acid (CBDA) (Claim 19).
Conclusion
Claims 1-19 are rejected.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 8:30 am - 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
400 Dulany Street
Alexandria, VA 22314-5774
Tel. No.: (571) 272-9038
1 US ‘485 qualifies as prior art under 35 U.S.C. 102(a)(1) because the earliest effective filing date afforded the claimed invention is June 26, 2023.