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 responsive to the Response to Election/Restriction and Amendment filed 08/11/2025, which amended claims 1and 12, cancelled claims 4-8, 10, and 13-14, and added claims 18-28.
Claims 1-3, 9, 11-12 and 15-28 are pending.
Priority
This application claims the following priority:
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Abstract
The abstract of the disclosure is objected to because:
-The last sentence of the abstract does not make sense. It is not clear if “is formulated as” is a typo and should read “in the form of,” or if the last sentence is communicating something else.
-The numbers “55936268” should be removed following the paragraph.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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Claims 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.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 and 18-28 are examined on the merits herein.
Claim Objections
Claims 1, 2, 9, 19-21, 24, and 26-28 are objected to because of the following informalities:
-In the 5th line of the definition of R1-R9, in claim 1, the comma following “optionally substituted” and prior to –(O)C1-6alkenyl, should be deleted.
--In the 4th line of the definition of Ra, in claim 1, the comma following “optionally substituted” and prior to –(O)C4-12cycloalkyl, should be deleted.
-In the 5th line of the definition of R1-R4, in claim 2, the comma following “optionally substituted” and prior to –(O)C5-12cycloalkyl, should be deleted.
-In the 4th line of the definition of Ra, in claim 2, the comma following “optionally substituted” and prior to –(O)C4-12cycloalkyl, should be deleted.
-In claim 1, in the last line of the definition of R1-R9, the phrase “ the dashed bond is present or absent;” should be placed in its own line and differentiated from the definition of R1-R9.
-In claim 9, “or a pharmaceutically acceptable salt, solvates, and combinations of the foregoing” should be replaced with - -or a pharmaceutically acceptable salt, solvate, or combinations of the foregoing- -.
-In claims 19-20, line 2, the term “the” prior to “liver” should be deleted.
-In claim 21, lines 1-2, “the expression” should be replaced with - -expression- -.
-In claim 24, line 2, “the production” should be replaced with - - production- -.
-In claim 26, lines 1-2, “the redistribution,” should be replaced with - -redistribution- -.
-In claim 27, line 2, “the level” should be replaced with - -levels- -.
-In claim 28, line 2, “the ratio” should be replaced with - -ratios- -.
Appropriate correction is required.
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.
Claims 3, 12, 18-24, and 26-28 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 3 recites the limitation "the composition" in line 1. There is insufficient antecedent basis for this limitation in the claim.
-Claim 12 recites the limitation "the composition" in line 1. There is insufficient antecedent basis for this limitation in the claim.
-Claims 18 and 22 recite the limitation "the induced lipophagy.” There is insufficient antecedent basis for this limitation in the claim.
-Claim 21 recites the limitation "the lipophagy" in line 1. There is insufficient antecedent basis for this limitation in the claim.
-Claim 24 recites the limitation "the composition" in line 1. There is insufficient antecedent basis for this limitation in the claim.
-Claim 26 recites the limitation "the inducement of lipophagy" in line 1. There is insufficient antecedent basis for this limitation in the claim.
-Claim 27 recites the limitation "the composition" in line 1. There is insufficient antecedent basis for this limitation in the claim.
-Claim 28 recites the limitation "the composition" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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(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.
Claims 9 and 11-12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
-Claims 9 and 11-12, which depend from claim 1, recite “wherein the compound of Formula (I) or Formula (II) is. . .” or “of Formula (I) or (II).” However, claim 1 only recites “a compound of Formula (I).” As such, claims 9 and 11-12 fall outside of the scope of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)-Written Description
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.
Claims 1, 3, 11-12 and 18-28 are 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.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See MPEP 2163.
Independent claim 1 recites:
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.
However, the instant specification provides no limiting definition or exemplification of homodimers, heterodimers, or conjugates of compounds of Formula (I).
Regarding homodimers and heterodimers, paragraph [0098] states:
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While Applicant references a publication which teaches the isolation of a cross-linked N-transferuloyltyramine dimer from potato common scab lesions, Applicant provides no data showing that the activity of this compound and its cross-linked dimer has or is known to have the same activity, let alone the same activity to treat a disease. Further, Applicant’s definition of homo and hetero-dimers includes any type of cross-linker, and Applicant’s definition of heterodimer encompasses a compound of Formula (I) and any compound containing a hydroxycinnamic acid amide.
Regarding conjugates, paragraph [0099] states:
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As such, conjugates can include any other compound, protein, nucleic acid, etc, combined with a compound of Formula (I).
The instant specification exemplifies only a single compound of Formula (I) for use in its methods, which is N-trans-caffeoyltyramine (NCT),
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in paragraphs [0177]-[0184], [0195]-[0207].
[0209] of the specification teaches its quest to find more potent HNF4alpha activators, and states that there is similarity in the structure of NCT and N-trans feruloyltyramine (NFT),
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, wherein NFT is taught as being derived from NCT.
Thus, NCT and NFT differ in that one of the hydroxyl groups in NCT is replaced with a methoxy group in NFT, a difference of a methyl group.
[0210] of the specification states that NCT was the strongest inducer of insulin promoter activity while NFT was approximately as active as alverine, wherein [0209] teaches alverine as a relatively weak activator. [0210] additionally teaches that NCT is more potent then NFT.
Notably [0210] states, regarding NCT and NFT, “As expected for nuclear receptor ligands, which are well-known for having highly sensitive structure-activity relationships, small structural differences resulted in large changes in activity (FIG. 5). NCT, which was more potent than NFT, differs from NFT by a single methyl group.”
In view of this teaching of unpredictability by Applicant, it is clear that it is not possible to determine a structure-function relationship between homodimers, heterodimers, or conjugates of compounds of formula (I) that is critical to induce autophagy in mammals, since the activity of structurally similar compounds differing by merely a methyl group, is empirically distinct.
While the prior art, WO 2019/140052 to Chae (PTO-892), teaches a method of modulating metabolism comprising administering a compound of Formula (I) and isomers, salts, homodimers, heterodimers, or conjugates thereof (pg. 60, claim 1), it only exemplifies compounds of formula (I) structurally, i.e., the compounds recited in instant claim 9 ([0035]), and only exemplifies NCT and NFT for modulating metabolism (see the examples beginning in [0092]).
The prior art is silent regarding homodimers, heterodimers, or conjugates of compounds of Formula (I) for inducing autophagy.
Thus, neither the instant specification nor the prior art provide a representative number of species of homodimers, heterodimers, or conjugates of compounds of Formula (I) that provide any structure-function correlation; it is impossible to determine a structure-function relationship between these compounds that is critical to induce autophagy.
For these reasons, the recitation of homodimers, heterodimers, or conjugates of compounds of Formula (I), 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 join inventor, at the time the application was filed, has possession of homodimers, heterodimers, or conjugates of compounds of Formula (I) for use in inducing autophagy.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 9, 11, and 18-28 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2019/140052 to Chae (published 07/18/2019, PTO-892).
Regarding claim 1-3, and 11, 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, salt, homodimer, heterodimer, or conjugate thereof, wherein the subject has or is at risk of developing a metabolic disorder (pg. 60, claim 1; pgs. 61-62, claims 6-7).
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 having or at risk of developing a metabolic disorders, 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., a metabolic disorder) in the same dosage amount (the instant specification teaches a dose of a compound of Formula (I) in the range of about 0.1-200 mg/kg ([0136]-[0137]), and Chae teaches a dose of a compound of Formula (I) in the range of about 0.0001mg/kg to about 10g/kg ([0087])), to the same patient population (patients that would benefit from induced autophagy), 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).
Further regarding claims 1-2, 9, and 25, Chae exemplifies the efficacy of its methods in diet induced obese mice to show of 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 120 mg/kg N-transcaffeoyltyramine. Results showed that N-transcaffeoyltyramine treatment decreased lipid accumulation, reduced lipid droplet sizes, and significantly reduced triglycerides (Example 3, [00112]-[00114]; Figures 7-10).
As evidenced by the instant specification and instant claim 18-20, inducing autophagy treats hepatic steatosis (Instant specification [0209], [0219]-[0223]; [0232]).
Regarding, in claim 1, “wherein upon said administration of said compound to the mammal in need thereof, autophagy is induced in hepatocytes,” and regarding claims 18-24, and 25-28, 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 an effective amount of a compound of Formula (I), (i.e., N-trans-caffeoyltyramine) to a patient in need of autophagy or a patient with hepatic steatosis. As such, Chae meets these limitations.
Further 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).
It is additionally noted that Chae 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])).
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.
Claims 1-3, 9, 11-12, and 18-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/140052 to Chae (published 07/18/2019, PTO-892).
Chae is applied to claims 1-3, 9, 11, and 18-28 as discussed above and incorporated herein.
Regarding claim 12, while Chae teaches a method of treating a metabolic disorder and hepatic steatosis (i.e., diseases that benefit from induced autophagy) by administering a composition comprising a compound of instant Formula (I), it differs from that of instant claim 12 in that it does not teach a dose range of 0.1-100mg/kg of a compound of Formula (I).
Regarding claim 12, 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 modify the amount of the compound of formula (I) administered in the methods of Chae, to arrive at instant claim 12. One of ordinary skill in the art would have been motivated to make such a modification 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 a modification to predictably arrive at a method that is optimized for therapeutic effect, i.e., treating of a metabolic disorder, such as hepatic steatosis.
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.
Claims 1-3, 9, 11-12, and 18-28 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 claim 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 ‘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., a metabolic disorder) in the same dosage amount (the instant specification teaches a dose of a compound of Formula (I) in the range of about 0.1-200 mg/kg ([0136]-[0137]), and ‘136 teaches a dose of a compound of Formula (I) less than 100mg), to the same patient population (patients that benefit from induced autophagy), 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, in claim 1, “wherein upon said administration of said compound to the mammal in need thereof, autophagy is induced in hepatocytes,” and regarding claims 18-24, and 25-28, 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 an effective amount of a compound of Formula (I), (i.e., N-trans-caffeoyltyramine) to a patient in need of autophagy or a patient with hepatic steatosis. As such, Chae meets these limitations.
Claims 1-3, 9, 11-12, and 18-28 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, in claim 1, “wherein upon said administration of said compound to the mammal in need thereof, autophagy is induced in hepatocytes,” and regarding claims 18-24, and 25-28, 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 an effective amount of a compound of Formula (I), (i.e., N-trans-caffeoyltyramine) to a patient in need of autophagy or a patient with hepatic steatosis. As such, administering the composition of ‘323 meets these limitations.
Regarding instant claim 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.
Claims 1-3, 9, 11-12, and 18-28 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, in claim 1, “wherein upon said administration of said compound to the mammal in need thereof, autophagy is induced in hepatocytes,” and regarding claims 18-24, and 25-28, 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 an effective amount of a compound of Formula (I), (i.e., N-trans-caffeoyltyramine) to a patient in need of autophagy or a patient with hepatic steatosis. As such, administering the composition of ‘392 meets these limitations.
Regarding instant claim 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.
Claims 1-3, 9, 11-12, and 18-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 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/day of N-trans caffeoyltyramine, or a salt thereof, a compound of instant Formula (I) (claim 1).
‘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).
Regarding instant claim 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 12 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, in claim 1, “wherein upon said administration of said compound to the mammal in need thereof, autophagy is induced in hepatocytes,” and regarding claims 18-24, and 25-28, 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 an effective amount of a compound of Formula (I), (i.e., N-trans-caffeoyltyramine) to a patient in need of autophagy or a patient with hepatic steatosis. As such, Chae meets these limitations.
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, and 18-28 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.
‘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, in claim 1, “wherein upon said administration of said compound to the mammal in need thereof, autophagy is induced in hepatocytes,” and regarding claims 18-24, and 25-28, 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 an effective amount of a compound of Formula (I), (i.e., N-trans-caffeoyltyramine) to a patient in need of autophagy or a patient with hepatic steatosis. As such, administering the composition of ‘323 meets these limitations.
Regarding instant claim 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claim have not in fact been patented.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622