DETAILED ACTION
All rejections and objections not mentioned below have been withdrawn.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/23/2026 has been entered.
Claim Interpretation
Since the specification does not indicate what is specifically required to provided “inducing cardiomyocyte proliferation sufficient to increase cardiac contractile force or increase the thickness of the myocardium” or “wherein the cardiovascular disease is treated by reversing and/or reducing remodeling”(claim 5) other than the generic method of claims 1 or 26 the claims are interpreted as any method of claims 1 or 26 would have these effects inherently. This is the broadest reasonable interpretation of the claims.
Claim Rejections - 35 USC § 103 -Updated due to Amendments
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, 4-5, 8, 11, 13, 26-28, 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li ( Li et al., Uptake and Protective Effects of Ergothioneine in Human Endothelial Cells, J Pharmacol Exp Ther 350:691–700, September 2014, previously provided) in view of Matsuzawa(Matsuzawa et al., Age‐Dependent Predictive Value of Endothelial Dysfunction for Arrhythmia Recurrence Following Pulmonary Vein Isolation, Journal of the American Heart Association, Volume 5, Issue 9, September 2016, previously provided).
The reference Li teaches “In summary, ergothioneine is taken up by endothelial cells via OCTN-1, where the compound then protects against oxidative stress, curtailing endothelial dysfunction”(abstract) and “Endothelial dysfunction is associated with a number of cardiovascular disease processes, including hyper tension, atherosclerosis, heart failure, coronary syndrome, and stroke (Fèlètou and Vanhoutte, 2006)”(page 691). This helps to teach treating hypertensive heart disease because it would be obvious to one of ordinary skill in the art to use ergothioneine to treat endothelial dysfunction which is suggested to curtail cardiovascular hypertension and thus curtail hypertensive heart disease.
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The reference Li teaches “Endothelium-Dependent Relaxations. To study endothelium-dependent relaxations, rat basilar arteries were contracted with the thromboxane-prostanoid receptor agonist U46619 (100 nM) and exposed to increasing concentrations of acetylcholine. Ergothioneine itself had no effect on acetylcholine-induced relaxations. Preincubation with pyro gallol (100 mM), hypoxanthine (1 mM) plus xanthine oxidase (10 mU), or glucose (25 mM) impaired the acetylcholine induced relaxations (Fig. 9). This impairment in relaxation was inhibited by ergothioneine in a concentration-dependent manner, and this effect was comparable to that of tiron (10 mM). Streptozotocin-induced diabetes resulted in a blunting of the maximal relaxation by acetylcholine of the basilar artery to 33%(Fig.10). Chronic treatment with ergothioneine(100 or 1000mg/kg per day) did not affect the response to acetylcholine of basilar arteries of control rats. Ten and 100 mg/kg per day of ergothioneine also had no significant effect on acetylcholine induced relaxations in preparations of streptozotocin-treated rats. However, when the streptozotocin-treated rats were fed with a higher dosage of ergothioneine (1000 µg/kg per day) for 6 weeks, the maximal relaxation by acetylcholine averaged 73%(Fig. 10). This effect was significantly greater than that of vitamin C (1000 mg/kg per day) and comparable to that of apocynin (16 mg/kg per day) (Fig. 10)” (page 694) and “Consistent with earlier work on endothelial dysfunction, the present study shows that relaxations by the endothelium dependent vasodilator acetylcholine (Furchgott and Zawadzki, 1980) were dampened by ROS producers (pyrogallol, hypoxanthine/ xanthine oxidase) (Abrahamsson et al., 1992; Kamata et al., 2006) and hyperglycemic conditions (25 mM glucose in vitro, streptozotocin-induced diabetes in vivo) (Pieper et al., 1995; Guoetal., 2000; Leo et al., 2011). This oxidative stress–associated impairment of relaxations was prevented by ergothioneine. Importantly, ergothioneine was more potent than vitamin C in protecting the endothelial integrity and vascular function, reflecting the potential beneficial effects of the substance in regard to vascular health. Ergothioneine has long been recognized as an antioxidant amino acid present in food (especially in mushrooms) (Kawano et al., 1982). The compound is rapidly cleared from the circulatory system and retained in the body with minimal metabolism (Mayumi et al., 1978). The absence of toxicity, high potency, and broad spectrum antioxidant properties, together with the high water solubility and stability at physiologic pH, make ergothioneine, especially when compared with existing conventional antioxidants, a very attractive candidate for protecting endothelial cells against oxidative stress and, thus, for the treatment and/or prevention of oxidative stress associated cardiovascular diseases”(page 699). It is also clear from this study that it is obvious to one of ordinary skill in the art to adjust dosage amounts based on progress of a cardiovascular disease.
The reference Li teaches “Uptake and Protective Effects of Ergothioneine in Human Endothelial Cells”(title). Thus it would have been obvious to one of ordinary skill in the art to treat humans with Ergothioneine after seeing protective effects in human cells.
This helps to teach 1, 4-5, 8, 11, 26-28, 30-33.
The reference Li does not teach human treatment with ergothioneine (1000 µg/kg per day) for 6 weeks for the treatment of hypertensive heart disease or determining susceptibility but instead suggest human treatment and does rat experiments. The reference Li also does not teach “inducing cardiomyocyte proliferation sufficient to increase cardiac contractile force or increase the thickness of the myocardium” (all claims) or “wherein the cardiovascular disease is treated by reversing and/or reducing remodeling”(claims 5 and 28) and does not disclose the specific diseases of all claims.
The reference Matsuzawa teaches “Atrial fibrillation (AF) is the most common type of sustained cardiac arrhythmia encountered in clinical practice and is associated with an increased risk of all-cause mortality and morbidity including stroke, heart failure, dementia, embolic events, hospitalization, and impaired quality of life”(page 1) and “Our findings imply that endothelial dysfunction might not only result from AF risk factors including hypertension but also directly cause AF”(page 10).
This helps to teach all claims.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Li with Matsuzawa because Li teaches curtailing endothelial dysfunction and Matsuzawa suggests endothelial dysfunction can cause AF. One have a reasonable expectation of success because ergothioneine was shown to treat endothelial dysfunction and one would be motivated to do so because ergothioneine’s absence of toxicity, high potency, and broad spectrum antioxidant properties, together with the high water solubility and stability at physiologic pH.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Li with Matsuzawa to treat humans with ergothioneine (1000 µg/kg per day) for 6 weeks for the treatment of hypertensive heart disease and AF because Li teaches it provides benefits in an animal models for treating endothelial dysfunction and thus it would be implicit to one of ordinary skill in the art as a starting point for human treatment. One would have motivation to do so to treat hypertensive heart disease and AF with a drug that has an absence of toxicity, high potency, and broad spectrum antioxidant properties, together with the high water solubility and stability at physiologic pH. One would have a reasonable expectation of success because the dosage is in µg/kg which means that a new proportional dosage can be scaled for human patients. Since any human is susceptible to cardiovascular disease. The step of determining susceptibility to cardiovascular disease and wanting to prevent such a disease from occurring would be obvious.
Since the specification does not indicate what is specifically required to provided “wherein the administration improves cardiac function by inducing cardiomyocyte proliferation sufficient to increase cardiac contractile force or increase the thickness of the myocardium” or “wherein the cardiovascular disease is treated by reversing and/or reducing remodeling”(claims 5 and 28) other than the generic method of claims 1 or 26 the claims are interpreted as any method of claims 1 or 26 would have these effects inherently. This is the broadest reasonable interpretation of the claims. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.) "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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").
Claim(s) 1, 6, 26, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li ( Li et al., Uptake and Protective Effects of Ergothioneine in Human Endothelial Cells, J Pharmacol Exp Ther 350:691–700, September 2014, previously provided) in view of Matsuzawa(Matsuzawa et al., Age‐Dependent Predictive Value of Endothelial Dysfunction for Arrhythmia Recurrence Following Pulmonary Vein Isolation, Journal of the American Heart Association, Volume 5, Issue 9, September 2016, previously provided) further in view of Trujillo (Trujillo et al., Antiarrhythmic Agents Drug Interactions of Clinical Significance, Drug Safety 2000 Dec; 23 (6): 509-532, previously provided).
The references Li and Matsuzawa have been discussed supra (and are incorporated herein by reference) and do not disclose the use of the antiarrhythmic agent of claims 6 or 29.
The reference Trujillo teaches “The management of cardiac arrhythmias has grown more complex in recent years. Despite the recent focus on nonpharmacological therapy, most clinical arrhythmias are treated with existing antiarrhythmics”(abstract) and “A drug interaction is defined as a reaction between 2 or more drugs that acts to enhance or inhibit the predicted response. An interaction between 2 or more agents maybe either beneficial or harmful, depending on the desired outcome”(page 512).
This helps to teach claims 6 and 29.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Li and Matsuzawa with Trujillo because Matsuzawa suggests endothelial dysfunction can cause AF and Trujillo teaches most clinical arrhythmias are treated with existing antiarrhythmics. One would be motivated to do so because a combination effect may enhance the treatment of antiarrhythmics and one would have a reasonable expectation of success because the drugs have suggested to treat cardiovascular diseases separately.
Claim(s) 1, 13, 22, 26 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li ( Li et al., Uptake and Protective Effects of Ergothioneine in Human Endothelial Cells, J Pharmacol Exp Ther 350:691–700, September 2014, previously provided) in view of Matsuzawa(Matsuzawa et al., Age‐Dependent Predictive Value of Endothelial Dysfunction for Arrhythmia Recurrence Following Pulmonary Vein Isolation, Journal of the American Heart Association, Volume 5, Issue 9, September 2016, previously provided) in view of WATANABE (WATANABE et al., JP 2014223051 A (2014), previously provided) further in view of Shiekh ( Shiekh et al., Engineering Bioinspired Antioxidant Materials Promoting Cardiomyocyte Functionality and Maturation for Tissue Engineering Application, ACS Appl. Mater. Interfaces 2018, 10, 3260−3273, previously provided).
The references Li and Matsuzawa have been discussed supra (and are incorporated herein by reference) and do not disclose the specific disease of claims 22 and 34.
The reference WATANABE teaches “The food containing the ergothioneine produced by the production method of the present invention or the composition of the present invention exhibits high antioxidant action, and therefore suppresses the production of active oxygen in the body, and the production of injuries due to active oxygen and the formation of lipid peroxides. And arteriosclerosis, hypertension, myocardial infarction, angina pectoris, cerebral infarction, cerebral hyperemia, diabetes, cancer, dementia, decreased immunity, metabolic syndrome and the like due to these can be expected”(page 5). This helps to teach claims 13, 22 and 34.
The reference Shiekh teaches “Oxidative stress has been also implicated in progression of various diseases, such as chronic wound inflammation, cardiovascular diseases, such as atherosclerosis and myocardial infarction… ”(page 3260-3261).
This helps to teach claims 13, 22 and 34.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Li and Matsuzawa with WATANAB and Shiekh because Li teaches ergothioneine, especially when compared with existing conventional antioxidants is a very attractive candidate for protecting endothelial cells against oxidative stress and, thus, for the treatment and/or prevention of oxidative stress associated cardiovascular diseases and WATANAB suggests ergothioneine for treatment of myocardial infarction caused by oxidative stress and Shiekh teaches this is a cardiovascular disease. One would be motivated to do so to treat myocardial infarction with ergothioneine because of its absence of toxicity, high potency, and broad spectrum antioxidant properties, together with the high water solubility and stability at physiologic pH. One would have a reasonable expectation of success both because it is suggested to treat cardiovascular diseases and because it is an antioxidant.
Response to Arguments
Applicant's arguments filed 08/21/2026 have been fully considered but they are not persuasive.
Claim Rejections - 35 USC § 103 -Updated due to Amendments
The applicant argues that “Li does not teach or suggest cardiomyocyte proliferation, cardiac contractile force, or myocardial thickness. Li's disclosed mechanism is directed exclusively to endothelial dysfunction and endothelium-dependent relaxations, which is a fundamentally different biological phenomenon from the claimed method's mechanism of inducing cardiomyocyte proliferation through upregulation of the kallikrein-kinin system. Li's experimental data are limited to in vitro cell assays and ex vivo isolated rat basilar artery rings, and Li contains no human subject data. None of Matsuzawa, Trujillo, Watanabe, or Shiekh cures these deficiencies, whether considered individually or in the combinations proposed by the Office Action” and “However, this reasoning fundamentally mischaracterizes the claimed invention. The claim is not directed to merely treating "oxidative stress" generically. Rather, it claims the specific result that systemic ergothioneine, administered at the claimed dose and duration, induces cardiomyocyte proliferation sufficient to increase cardiac contractile force or myocardial thickness. As explained above with respect to the § 102(a)(1) rejection, the claimed invention operates through a fundamentally different mechanism (kallikrein-kinin upregulation leading to plasminogen production and cardiomyocyte proliferation) than the passive antioxidant/ROS-scavenging mechanism attributed to ergothioneine in the cited references. (Liu Declaration 3(2), 4(c).) The combination ignores the fundamental mechanistic and contextual differences between a localized, high-content antioxidant biomaterial scaffold supporting neonatal cardiomyocyte growth in vitro (Shiekh) and systemic oral delivery of a dietary amino acid to an adult human heart (the claimed method)”. The applicant also argues “Second, routine optimization is inapplicable. The In re Aller doctrine applies only where "the general conditions of a claim are disclosed in the prior art." In re Aller, 220 F.2d 454, 456 (CCPA 1955). Here, the "general condition" of ergothioneine-induced cardiomyocyte proliferation sufficient to increase myocardial thickness or contractile force is nowhere disclosed in the prior art. There are no "workable ranges" to optimize because no reference establishes that the claimed functional outcome is achievable with ergothioneine at any dose. One cannot optimize to achieve a result that the prior art does not recognize as possible”. These are not considered a persuasive argument because it would be obvious to one of ordinary skill in the art that that an animal model suggests a starting point for human treatment. It is also clear from the prior art that humans are the desired subjects due to the experimentation on human cells. In addition the mechanism of action is considered inherent to the obvious method of treatment and thus not limiting. Since the specification does not indicate what is specifically required to provided “wherein the administration improves cardiac function by inducing cardiomyocyte proliferation sufficient to increase cardiac contractile force or increase the thickness of the myocardium” or “wherein the cardiovascular disease is treated by reversing and/or reducing remodeling”(claims 5 and 28) other than the generic method of claims 1 or 26 the claims are interpreted as any method of claim 1 or 26 would have these effects inherently. This is the broadest reasonable interpretation of the claims. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.) "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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").
The applicant also argues that “To the contrary, the prior art includes Cargnoni et al., which reported that ergothioneine failed to protect isolated ischemic and reperfused rabbit heart, Biochim Biophys Acta 1270:173-178 (1995), demonstrating that one of ordinary skill would not have expected ergothioneine to provide cardiac protection, much less the specific cardiomyocyte proliferation outcome required by claim 1”. This argument is not persuasive because one example where ergothioneine failed to protect isolated ischemic and reperfused rabbit heart does not remove other suggestions for heart protection based on Li and ergothioneine antioxidant properties (WATANABE).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The applicant further argues that “Claim 8 (dose-adjustment based on diagnosed stage or progress of disease) recites clinical monitoring and titration tied to cardiovascular disease progression; none of Li, Matsuzawa, Trujillo, Watanabe, or Shiekh teaches dose adjustment responsive to cardiomyocyte proliferation endpoints or myocardial structural metrics. Claim 11 (monitoring and dose adjustment based on detected cardiac improvement), as amended to depend directly from claim 1, is patentable for the reasons stated above with respect to claim 1, and for the additional specificity of its monitoring and titration limitation”. This is also not a persuasive argument because it is also clear from Li’s study that it is obvious to one of ordinary skill in the art to adjust dosage amounts based on progress of a cardiovascular disease or cardiac function.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Claims 1, 4-6, 8, 11, 13, 22 and 26-34 are rejected.
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.
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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