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
This Office Action is in response to Applicant’s Arguments and Amendment filed, 04/06/2026, wherein the Amendment amended claims 1-3, 9, 11-12, 15, 18-22, 24, 26, and 28, and canceled claim 27.
Claims 1-3, 9, 11-12, 15-26, and 28 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of Group I, the method of treatment, and N-trans-caffeoyltyramine,
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, as the compound of formula (I) in the reply filed on 08/11/2025, is acknowledged.
Claims 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
Claims 1-3, 9, 11-12, 18-26, and 28 are examined on the merits herein.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Abstract Objections
Applicant’s amendments to the abstract are sufficient to overcome this objection.
Claim Objections, 35 U.S.C. § 112(b), 35 U.S.C. § 112(d)
Applicant’s amendments to the claims are sufficient to overcome these objections and rejections.
35 U.S.C. § 112(a)
Applicant’s amendments to the claims, which deleted “homodimer, heterodimer, or conjugate,” and amendments to the definitions of R1-R9, X, and Ra, are sufficient to overcome this rejection.
35 U.S.C. § 102
Applicant’s amendment to claim 1 that adds dosage limitations is sufficient to overcome this rejection.
REJECTIONS—MAINTAINED, MODIFIED, & NEW
Claim Rejections - 35 USC § 112(a)-New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(New) Claims 1-3, 9, 11-12, 18-26, and 28 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
The recitations “wherein the administration of the compound increases levels of circulating free fatty acids in the mammal” and “wherein the administration of the compositions causes mobilization of hepatic lipid into circulating free fatty acids followed by uptake and storage in adipose tissue,” in the last seven lines of claim 1, is new matter.
While [0180] teaches that N-trans-caffeoyltyramine increases free fatty acids, this does not provide support for all compounds of instant Formula (I) having this property.
Though Applicant points to [0215]-[0217] and Figs. 19, 23, 47 and 51 for support of these phrases, these paragraphs and figures do not provide support. [0215]-[0217], Figs. 19 and 23, teach that S1P transporter SPNS2 is required for fat clearance by N-transcaffeoyltyramine, a compound of instant Formula (I), and that dihydroceramides are required for fat clearance by N-transcaffeoyltyramine, which does not provide support for the above recitations. Fig. 47 shows that in vitro, N-trans-caffeoyltyramine and N-transferuloyltyramine induced HNF4alpha expression in T6PNE cells and primary human hepatocytes. Fig. 51 shows that N-trans-caffeoyltyramine did not induce a change in SPNS2 expression in mouse liver.
As such, the original disclosure does not provide support for these phrases.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
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.
(New) Claim 12 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 12 recites “Formula (I) is in a unit dosage form and is configured for administration from about 125 mg,” which renders the claim indefinite. It is not clear if a range is intended to be recited and the maximum mg amount of the range is missing from the claim, or if a single mg amount of about 125mg is intended to be recited.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
(Modified) Claims 1-3, 9, 11-12, 18-26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/140052 to Chae (published 07/18/2019, PTO-892).
Regarding claim 1-3, and 11-12, Chae teaches a method for modulating metabolism by administering to a subject, a composition comprising a carrier and a compound of:
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, or an isomer, or salt, thereof, wherein the subject has or is at risk of developing a metabolic disorder, such as insulin resistance, hyperglycemia, type II diabetes mellitus, obesity, glucose intolerance, hypercholesterolemia, hyperlipoproteinemia, dyslipidemia, hyperinsulinemia, coronary artery disease , metabolic syndrome, or hypertension. (pg. 60, claim 1; pgs. 61-62, claims 6-7).
Regarding claims 1 and 12, while Chae teaches a method of treating a metabolic disorders by administering a composition comprising a compound of instant Formula (I), it differs from that of instant claims 1 and 12 in that it does not teach a dose range of 0.1-100mg/kg of a compound of Formula (I) or from about 125mg.
Chae teaches ~0.001mg/kg-10g/kg as a suitable daily dose of its compounds. Chae teaches that a suitable daily dose of a compound is that amount which is the lowest dose that is effective at producing a desired effect. Such an effective dose depends upon many factors ([0087]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select 0.1 to 100mg/kg, or about 125mg, as the amount of the compound of formula (I) administered in the methods of Chae, to arrive at instant claims 1 and 12. One of ordinary skill in the art would have been motivated to make such selections, with a reasonable expectation of success, because:
-in the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists (MPEP 2144.05), and
-"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" (MPEP 2144.05(II)).
As such, an artisan having ordinary skill would have been motivated to make such selections to predictably arrive at a method that is optimized for therapeutic effect, i.e., treating a metabolic disorder, and optimized to minimize adverse side effects by administering the lowest dose that is effective at producing a desired effect.
Further regarding claim 1, [0172] of the instant specification states, “A subject in need of a composition of this disclosure includes a subject with observable symptoms associated with a fatty liver, as well as a subject who has no observable symptoms of a fatty liver but has been determined to be susceptible to development a fatty liver. A subject in need of a composition of this disclosure includes a subject with observable symptoms associated with a non-alcoholic fatty liver, as well as a subject who has no observable symptoms of a fatty liver but has been determined to be susceptible to developing a non-alcoholic fatty liver,” wherein insulin resistance, hyperglycemia, type II diabetes mellitus, obesity, glucose intolerance, hypercholesterolemia, hyperlipoproteinemia, dyslipidemia, hyperinsulinemia, coronary artery disease, metabolic syndrome, or hypertension, which are diseases taught by Chae, are diseases in which subjects are susceptible to developing liver disease, and wherein [0001] of the instant specification specifically teaches obesity as a disease that causes or is susceptible to causing a fatty liver.
Moreover, Chae exemplifies the efficacy of its methods in diet induced obese mice to show the beneficial effects of N-trans-caffeoyltyramine on hepatic steatosis. Twelve mice were fed a high fat diet to induce obesity, and while on the high fat diet, six mice were administered N-transcaffeoyltyramine. Results showed that N-transcaffeoyltyramine treatment decreased lipid accumulation, reduced lipid droplet sizes, and significantly reduced triglycerides in the liver (Example 3, [00112]-[00114]; Figures 7-10).
Chae additionally exemplifies a) a triglyceride assay in cultured hepatocytes, wherein hepatocytes are cultured in the presence of the compounds of Chae, and triglyceride synthesis is measured, b) administering the compounds of Chae to mice, collecting the blood and assessing triglycerides; c) administering the compounds of Chae to mice modified with hepatic steatosis to demonstrate in vivo response for compounds of Chae; d) in-vitro administration of N-trans-caffeoyltyramine to human, rat and mouse hepatic microsomes; d) analyzing HepG2 liver cells treated with N-transcaffeoyltyramine or N-trans-feruloyltyramine to show that these compounds are capable of clearing harmful fats from the liver; e) a steatosis assay in which HepG2 cell lines are administered N-trans-caffeoyltyramine or p-coumaroyltyramine and the amount of alkaline phosphatase, the amount of triglyceride, and the lipid droplet size are analyzed ([0050]-[0051]; [0056]; [0059]; [0076]; [0096]-[0099]; [00109]-[00110])).
As evidenced by the instant specification and instant claim 18-20, inducing autophagy treats hepatic steatosis (Instant specification [0209], [0219]-[0223]; [0232]), and as evidenced by instant claim 25, inducing autophagy treats mammals with diet-induced obesity, and as discussed above, Chae exemplifies a method of treating hepatis steatosis in diet-induced obese mice.
Thus, while Chae does not explicitly teach a method for inducing autophagy, it is reasonable to assume that administering a composition comprising a compound of instant Formula (I) to patients with obesity, metabolic syndrome, and hepatis steatosis, would have the same properties, since the composition is administered for the same purpose (treating obesity, metabolic syndrome, or hepatis steatosis, which are diseases that are susceptible to developing a fatty liver or which have a fatty liver) in the same dosage amounts (0.1-10 mg/kg), to the same patient population (patients with or susceptible to developing fatty livers, such as those with metabolic syndrome, obesity, or hepatic steatosis), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach “inducing autophagy,” burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding, the wherein clauses in claims 1, 18-24, 26 and 28, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)), see MPEP 2111.04. In the instant case, the wherein clauses express the desired result of the positive step of administering 0.1-10mg/kg of a compound of Formula (I), (N-trans-caffeoyltyramine, for example,) to a patient in need of autophagy, such as a patient with hepatic steatosis, obesity, or metabolic syndrome. As such, Chae meets these limitations.
See also MPEP 2112.02; “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.”
Regarding claims 2, 9, and 11, Chae teaches compounds of formula (I) and salts thereof, such as N-transcaffeoyltyramine
Regarding claim 3, Chae teaches formulating the composition as a dietary supplement, food ingredients/additive, medical food, nutraceutical or pharmaceutical composition (pg. 61, claim 4).
Regarding claim 25, Chae exemplifies a method of treating hepatis steatosis in diet-induced obese mice.
Response to Arguments
On pg. 10, Remarks, Applicant argues that Chae discloses reduction of lipid accumulation and improvement of metabolic parameters, but Chae is silent as to the physiological destination of mobilized hepatic lipid, and does not disclose, teach, or describe that fat released from hepatocytes enters circulation and is subsequently redeposited in adipose tissue. As such, Applicant argues that “The redistribution of lipid is therefore not an intended result or an unclaimed consequence, but a required functional outcome of the claimed method.”
On pg. 11, Remarks, Applicant argues that redistribution of fat to adipose tissue is not an inherent or inevitable consequence of hepatic lipid reduction.
On pg. 12, Remarks, Applicant argues that even if a skilled artisan sought to reduce hepatic lipid accumulation, there would have been no reasonable expectation of success that practicing Chae’s methods would result in the claimed redistribution of fat into adipose tissue.
These arguments have been fully considered, but are not found persuasive.
As discussed in the above rejection, the method of Chae administers the same compound, i.e., compounds of formula (I) and specifically N-trans-caffeoyltyramine, in the same dosage amounts, to the same patient population, i.e., patients with hepatic steatosis, obesity, and metabolic syndrome. As such, the methods of Chae would necessarily induce autophagy, increase levels of circulating free fatty acids, and cause mobilization of hepatic lipid into circulating free fatty acids followed by uptake and storage in adipose tissue.
Additionally, as discussed in MPEP 2145(II), “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. . .’The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.’”
On pg. 12, Remarks, Applicant argues that Chae does not identify nor does it state to select this specific population to be treated, but that Chae is directed to the treatment of conditions characterized by lipid excess, and that because Chae seeks to resolve conditions or excess fat, a skilled artisan would not be motived to practice Chae’s method if it were expected to result in the active shuttling and storage of fat into adipose tissue.
This argument has been fully considered, but is not found persuasive.
As discussed in the above rejection:
Regarding claim 1, [0172] of the instant specification states, “A subject in need of a composition of this disclosure includes a subject with observable symptoms associated with a fatty liver, as well as a subject who has no observable symptoms of a fatty liver but has been determined to be susceptible to development a fatty liver. A subject in need of a composition of this disclosure includes a subject with observable symptoms associated with a non-alcoholic fatty liver, as well as a subject who has no observable symptoms of a fatty liver but has been determined to be susceptible to developing a non-alcoholic fatty liver,” wherein insulin resistance, hyperglycemia, type II diabetes mellitus, obesity, glucose intolerance, hypercholesterolemia, hyperlipoproteinemia, dyslipidemia, hyperinsulinemia, coronary artery disease, metabolic syndrome, or hypertension, diseases taught by Chae, are diseases in which subjects are susceptible to developing liver disease, and wherein [0001] of the instant specification specifically teaches obesity as a disease that causes or is susceptible to causing a fatty liver.
Moreover, Chae exemplifies the efficacy of its methods in diet induced obese mice to show the beneficial effects of N-trans-caffeoyltyramine on hepatic steatosis. Twelve mice were fed a high fat diet to induce obesity, and while on the high fat diet, six mice were administered N-transcaffeoyltyramine. Results showed that N-transcaffeoyltyramine treatment decreased lipid accumulation, reduced lipid droplet sizes, and significantly reduced triglycerides in the liver (Example 3, [00112]-[00114]; Figures 7-10).
Chae additionally exemplifies a) a triglyceride assay in cultured hepatocytes, wherein hepatocytes are cultured in the presence of the compounds of Chae, and triglyceride synthesis is measured, b) administering the compounds of Chae to mice, collecting the blood and assessing triglycerides; c) administering the compounds of Chae to mice modified with hepatic steatosis to demonstrate in vivo response for compounds of Chae; d) in-vitro administration of N-trans-caffeoyltyramine to human, rat and mouse hepatic microsomes; d) analyzing HepG2 liver cells treated with N-transcaffeoyltyramine or N-trans-feruloyltyramine to show that these compounds are capable of clearing harmful fats from the liver; e) a steatosis assay in which HepG2 cell lines are administered N-trans-caffeoyltyramine or p-coumaroyltyramine and the amount of alkaline phosphatase, the amount of triglyceride, and the lipid droplet size are analyzed ([0050]-[0051]; [0056]; [0059]; [0076]; [0096]-[0099]; [00109]-[00110])).
As evidenced by the instant specification and instant claim 18-20, inducing autophagy treats hepatic steatosis (Instant specification [0209], [0219]-[0223]; [0232]), and as evidenced by instant claim 25, inducing autophagy treats mammals with diet-induced obesity, and as discussed above, Chae exemplifies a method of treating hepatis steatosis in diet-induced obese mice.
Thus, while Chae does not explicitly teach a method for inducing autophagy, it is reasonable to assume that administering a composition comprising a compound of instant Formula (I) to patients with diseases, such as obesity, metabolic syndrome, and hepatis steatosis, would have the same properties, since it is administered for the same purpose (treating obesity, metabolic syndrome, or hepatis steatosis, which are diseases susceptible to developing a fatty liver or which have a fatty liver) in the same dosage amounts (0.1-10 mg/kg), to the same patient population (patients with or susceptible to developing fatty livers, such as those with metabolic syndrome, obesity, or hepatic steatosis), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach “inducing autophagy,” burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding, the wherein clauses in claims 1, 18-24, 26, and 28, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)), see MPEP 2111.04. In the instant case, the wherein clauses express the desired result of the positive step of administering 0.1-10mg/kg of a compound of Formula (I), (i.e., N-trans-caffeoyltyramine) to a patient in need of autophagy, i.e., a patient with hepatic steatosis, obesity, or metabolic syndrome. As such, Chae meets these limitations.
See also MPEP 2112.02; “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.”
Applicant has not shown that the methods of Chae, which administers the same compound, i.e., compounds of formula (I) and specifically N-trans-caffeoyltyramine, in the same dosage amounts, to the same patient population, i.e., patients with hepatic steatosis, obesity, and metabolic syndrome, would not necessarily a) induce autophagy; b) increase levels of circulating free fatty acids, and c) cause mobilization of hepatic lipid into circulating free fatty acids followed by uptake and storage in adipose tissue.
As such, these arguments are not persuasive to overcome the instant rejection.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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.
(Modified) Claims 1-3, 9, 11-12, 18-26, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,173,136 (IDS of 12/20/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘136 claims a method for treating a metabolic disorder selected from obesity, fatty liver disease, and more by administering an oral composition comprising a compound of instant Formula (I) (claim 1), wherein the claimed subjects with metabolic disorders would benefit from induced autophagy.
‘136 claims Formula (II) (claim 2).
‘136 claims the composition in the form of a dietary supplement and more (claim 4).
‘136 claims the compounds of instant claim 9 (claim 7).
‘136 claims administration of less than 100mg/day (claim 8). Regarding instant claims 1 and 12, the optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding instant claim 1, [0172] of the instant specification states, “A subject in need of a composition of this disclosure includes a subject with observable symptoms associated with a fatty liver, as well as a subject who has no observable symptoms of a fatty liver but has been determined to be susceptible to development a fatty liver. A subject in need of a composition of this disclosure includes a subject with observable symptoms associated with a non-alcoholic fatty liver, as well as a subject who has no observable symptoms of a fatty liver but has been determined to be susceptible to developing a non-alcoholic fatty liver,” wherein obesity and fatty liver disease are diseases in which subjects have or are susceptible to developing liver disease, and wherein [0001] of the instant specification specifically teaches obesity as a disease that causes or is susceptible to causing a fatty liver.
While ‘136 does not explicitly teach a method for inducing autophagy, it is reasonable to assume that administering a composition comprising a compound of instant Formula (I) to patients with the recited metabolic disorders of ‘136 would have the same properties since it is administered for the same purpose (treating or prophylactically treating a disease that would benefit from induced autophagy, i.e., obesity or fatty liver disease) in the same dosage amount, to the same patient population (patients with obesity or fatty liver disease who have or are susceptible to developing liver disease), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach “inducing autophagy,” burden is on Applicant to show that the prior art does not have these properties.
Regarding claim 18, since the methods of ‘136 treat fatty liver disease, it is reasonable to assume that the method of claim 1 would reduce hepatic steatosis, which is caused, in part by, fatty liver disease (see [0001] of the instant specification).
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding, the wherein clauses in claims 1, 18-24, 26 and 28, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)), see MPEP 2111.04. In the instant case, the wherein clauses express the desired result of the positive step of administering 0.1-10mg/kg of a compound of Formula (I), (i.e., N-trans-caffeoyltyramine) to a patient in need of autophagy or a patient with a disease such as a hepatic steatosis, obesity, or metabolic syndrome. As such, ‘236 meets these limitations.
See also MPEP 2112.02; “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.”
Regarding claim 25, while ‘136 does not explicitly teach the obesity as diet induced obesity, and ordinary skilled artisan would have reasonably assumed, with a reasonable expectation of success, that the methods of ‘136 would treat diet-induced obesity since it teaches treating obesity, in general.
Claims 1-3, 9, 11-12, 18-26, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,642,323 (IDS of 12/20/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘323 claims an oral composition comprising N-trans-caffeoyltyramine or N-trans-feruloyltyramine; or comprising N-trans-caffeoyltyramine or p-coumaroyltyramine, and a carrier (claims 1, 5, 19, 25).
‘323 further comprises p-coumaryoyltyramine (claim 2).
‘323 claims the composition in the form of a dietary supplement and more (claim 4, 5, 25).
‘323 teaches its methods for treating hepatic steatosis in diet induced obese mice (Col. 4, lines 20-50; Col. 10, line 66-Col. 11, line 5; Col. 18, lines 20-40; Col. 25, Example 3, beginning on line 55).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
Regarding instant claim 1 and 12, the optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding, the wherein clauses in claims 1, 18-24, 26 and 28, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)), see MPEP 2111.04. In the instant case, the wherein clauses express the desired result of the positive step of administering 0.1-10mg/kg of a compound of Formula (I), (i.e., N-trans-caffeoyltyramine) to a patient in need of autophagy or a patient with a disease such as a hepatic steatosis, obesity, or metabolic syndrome. As such, ‘323 meets these limitations.
See also MPEP 2112.02; “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.”
Claims 1-3, 9, 11-12, 18-26 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,285,392 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘392 claims an oral composition comprising N-trans-caffeoyltyramine, N-trans-feruloyltyramine, a suspending agent, and a carrier (claims 1, 11).
‘392 claims the composition in the form of a dietary supplement and more (claim 11).
‘392 teaches its methods for treating hepatic steatosis in diet induced obese mice (abstract).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
Regarding instant claim 1 and 12, the optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding, the wherein clauses in claims 1, 18-24, 26 and 28, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)), see MPEP 2111.04. In the instant case, the wherein clauses express the desired result of the positive step of administering 0.1-10mg/kg of a compound of Formula (I), (i.e., N-trans-caffeoyltyramine) to a patient in need of autophagy or a patient with a disease such as a hepatic steatosis, obesity, or metabolic syndrome. As such, ‘392 meets these limitations.
See also MPEP 2112.02; “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.”
Claims 1-3, 9, 11-12, 18-26 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 12, 19, and 23-24 of copending Application No. 18/415,255 (claim set dated 06/10/2024, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘255 claims a method for reducing body weight and treating nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, or diabetes by administering 30-400mg/kg/day of N-trans caffeoyltyramine, or a salt thereof, a compound of instant Formula (I) (claims 1-2).
‘255 claims the method as increasing fatty acid oxidation activity in the subject (claim 5).
‘255 claims a method for maintaining weight of a subject or reducing diet induced weight gain and treating nonalcoholic steatohepatitis by administering 30-400mg/kg N-trans caffeoyltyramine (claim 12).
‘255 claims the subject as having a high fat diet (claim 23).
‘255 claims the subject as having obesity (claim 24).
Regarding instant claims 1 and 12, the optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
While ‘255 does not explicitly teach a method for inducing autophagy, it is reasonable to assume that administering a N-trans caffeoyltyramine, a compound of instant Formula (I), to patients with nonalcoholic steatohepatitis, would have the same properties since it is administered for the same purpose (treating or prophylactically treating a disease that would benefit from induced autophagy, i.e., nonalcoholic steatohepatitis) in the same dosage amount (instant claim 1 recites 0.1-100mg/kg, and ‘255 claims 30-400mg/kg), to the same patient population (patients with nonalcoholic steatohepatitis), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach “inducing autophagy,” burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding, the wherein clauses in claims 1, 18-24, 26 and 28, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)), see MPEP 2111.04. In the instant case, the wherein clauses express the desired result of the positive step of administering 0.1-10mg/kg of a compound of Formula (I), (i.e., N-trans-caffeoyltyramine) to a patient in need of autophagy or a patient with a disease such as a hepatic steatosis, obesity, or metabolic syndrome. As such, ‘255 meets these limitations.
See also MPEP 2112.02; “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 9, 11-12, 18-26, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/419,387 (claim set dated 01/22/2024, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘387 claims an oral composition comprising N-trans-caffeoyltyramine or N-trans-feruloyltyramine; or comprising N-trans-caffeoyltyramine or p-coumaroyltyramine, and a carrier (claims 1, 14, 20).
‘387 claims salts (claim 2).
‘387 claims the composition in the form of a dietary supplement and more (claims 3-4, 15-16).
‘387 claims a less than 100mg/day unit dosage form, and claims 10-60mg/day of N-trans-caffeoyltyramine (claims 9-10).
‘387 claims its composition for the treatment of metabolic disorders (claims 17-19).
‘387 teaches its methods for treating hepatic steatosis in diet induced obese mice (Col. 4, lines 20-50; Col. 10, line 66-Col. 11, line 5; Col. 18, lines 20-40; Col. 25, Example 3, beginning on line 55).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
Regarding instant claims 1 and 12, the optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding, the wherein clauses in claims 1, 18-24, 26 and 28, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)), see MPEP 2111.04. In the instant case, the wherein clauses express the desired result of the positive step of administering 0.1-10mg/kg of a compound of Formula (I), (i.e., N-trans-caffeoyltyramine) to a patient in need of autophagy or a patient with a disease such as a hepatic steatosis, obesity, or metabolic syndrome. As such, ‘387 meets these limitations.
See also MPEP 2112.02; “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claim have not in fact been patented.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622
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