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 .
Priority
The instant application was filed 22 January 2024 and is the continuation of 16/510,005 filed 12 July 2019 and the continuation in part of PCT/US2019/012986 filed 10 January 2019. Applicant claims priority to provisional application 62/615,615 filed 10 January 2018. The effective filing date of the instant application is 10 January 2018.
Claim Objections
Claim 10 is objected to because of the following informalities: the claim recites “10 and 60 mg/day of N-trans-caffeoyltyramine a day.” Applicant is recommended to amend the claim to remove the redundant use of “day.” Appropriate correction is required.
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.
Claim(s) 1-3, 5, 8-14, 16, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okombi et al. (US 2007/0183996 A1), as evidenced by Cox (Pharma’s bread and butter is still made with powder, 2016).
Okombi teaches pharmaceutical compositions that may comprise extracts, such as N-trans-caffeoyltyramine and N-trans-feruloyltyramine (entire teaching; Table 1) for anti-inflammatory purposes (abs). Pharmaceutical composition is interpreted broadly to include topical and oral (tablet or liquid emulsion) compositions when unspecified by the inventor. Lactose and sucrose are listed as excipients (para. 131), which is interpreted as a sugar carrier, addressing claims 5 and 16. The composition may be formulated as a tablet (para. 131) or emulsion (Example 35), which is interpreted as an orally ingestible powder (evidenced by Cox, pg. 2) or liquid formulation, thus far addressing claims 1, 3, 14, and 20. Okombi describes a white precipitate (para. 58), which is interpreted as the compounds capable of being in its salt form, addressing claim 2. The pH of one formulation for topical use may be adjusted to 5.5 and when an emulsion, the pH may be 6.0-6.5 (para. 130), addressing claim 8. The composition may include propylparaben (Example 35), which is a preservative (para. 85 of instant specification), in an amount of 2%, addressing claims 11, 12, 18, and 19. Okombi also teaches the compounds as an ethanol extract (para. 33), addressing claim 13. Okombi teaches 0.001-0.1 g of the compounds (para. 131), which is interpreted as addressing the amounts in claims 9 and 10.
The limitation of the compounds derived from hemp in claim 1 is interpreted as a product-by-process limitation and is given minimal patentable weight. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
The limitation of “a dietary supplement, food ingredient or additive, a medical food, or nutraceutical for treating metabolic disorders” in claim 14 is interpreted as intended use and is given minimal patentable weight (see MPEP 2111.02(II)).
Okombi does not teach an exact combination of N-trans-caffeoyltyramine, N-trans-feruloyltyramine, a carrier, and in the form of a powder or granule in claim 1.
In regards to selecting the combination of N-trans-caffeoyltyramine, N-trans-feruloyltyramine, a carrier, and in the form of a powder or granule, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Okombi teaches tablet or liquid pharmaceutical compositions that may comprise N-trans-caffeoyltyramine and N-trans-feruloyltyramine for anti-inflammatory purposes, whereas the claimed invention is directed towards an oral composition comprising at least one carrier, N-trans-caffeoyltyramine, N-trans-feruloyltyramine, and in the form of a powder or granule. Since Okombi teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
In regards to the amounts described in claims 9 and 10, Okombi teaches 0.359 g of lactose, 0.240 g of sucrose, and 0.001-0.1 g of the compounds (para. 131). That being said and in lieu of objective evidence of unexpected results, the amounts can be viewed as a variable that achieves the recognized result of successfully making the oral composition comprising N-trans-caffeoyltyramine and N-trans-feruloyltyramine. The optimum or workable range of amounts or concentration can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of components or dosages as nonobvious.
Claim(s) 1-5, 8-16, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okombi et al. (US 2007/0183996 A1) and ElSohly (Marijuana and the Cannabinoids, 2007), as evidenced by Cox (Pharma’s bread and butter is still made with powder, 2016).
In regards to claim(s) 1-3, 5, 8-14, 16, 18-20, Okombi, as applied supra, is herein applied in its entirety for its teachings of pharmaceutical compositions that may comprise extracts, such as N-trans-caffeoyltyramine and N-trans-feruloyltyramine.
Okombi does not specifically teach the composition in the form of a food, such as an oil, in claims 4 and 15.
ElSohly teaches hemp seed oil as a nutraceutical (pg. 2). Hemp is interpreted as referring to cannabis sativa (pg. 9), which includes N-trans-caffeoyltyramine and N-trans-feruloyltyramine as compounds (pg. 29). Cannabis is known in the art to have anti-inflammatory properties (pg. 113).
Since Okombi does not specifically teach the composition in the form of a food, such as an oil, in claims 4 and 15, one of ordinary skill in the art would have been motivated to use the teaching that hemp seed oil as a nutraceutical may have anti-inflammatory properties from ElSohly with a reasonable expectation of success. A skilled artisan would have recognized the anti-inflammatory properties of utilizing N-trans-caffeoyltyramine and N-trans-feruloyltyramine as an oil for nutraceutical purposes. Generally, it is prima facie obvious to combine or substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okombi et al. (US 2007/0183996 A1), ElSohly (Marijuana and the Cannabinoids, 2007), and Handbook of Pharmaceutical Excipients (2009), as evidenced by Cox (Pharma’s bread and butter is still made with powder, 2016).
In regards to claim(s) 1-5, 8-16, 18-20, Okombi, as applied supra, is herein applied in its entirety for its teachings of pharmaceutical compositions that may comprise extracts, such as N-trans-caffeoyltyramine and N-trans-feruloyltyramine.
Okombi does not specifically teach carboxymethylcellulose or methylcellulose in claims 6, 7, and 17.
Handbook of Pharmaceutical Excipients teaches that carboxymethylcellulose sodium is used in oral and topical formulations to increase viscosity and also suspend powders intended for topical, oral, or parenteral administration (pg. 117). Methylcellulose is used in oral and topical formulations as binding agents, disintegrants, and sustained-release formulations (pg. 438).
Since Okombi does not specifically teach carboxymethylcellulose or methylcellulose in claims 6, 7, and 17, one of ordinary skill in the art would have been motivated to use the teaching that carboxymethylcellulose and methylcellulose have important purposes in oral formulations from Handbook of Pharmaceutical Excipients. A skilled artisan would have recognized the benefit of including carboxymethylcellulose or methylcellulose, such as for the purpose of increasing viscosity or suspending powders in oral formulations. Generally, it is prima facie obvious to combine or substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
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, 5-7, 9-12, 14, 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-12 of US 2022/0370383 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 1-4 of the reference recite a composition comprising N-trans-feruloyltyramine and N-trans-caffeoyltyramine, which corresponds to the same compounds in instant claims 1, 14, and 20.
Claim 6 recites a carrier, which corresponds to instant claims 5, 16, and 17.
Claims 7-9 recite a tablet or liquid, which corresponds to instant claims 1, 14, and 20.
Claim 10 recites a dietary supplement, food ingredient, or additive with the compounds, a carrier (carboxymethylcellulose in para. 74), and a preservative where the compound is in an amount of 0.1-99%, which corresponds to instant claims 1, 6, 7, 9-11, 14, 16-18, and 20.
Claim 11 recites a preservative amount of 0.01-1%, which corresponds to instant claims 12 and 19.
Claim 12 recites suitable preservatives, which corresponds to instant claims 11 and 18.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613