DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Applicant’s amendments to the claims of December 1, 2025, in response to the Office Action of May 30, 2025, are acknowledged.
Response to Arguments
The § 112 rejection is withdrawn in view of the amendments to claim 10.
Applicant argues that the prior art fails to teach the specific result of administration of the amended claims, which is a process that occurs in tissues undergoing chronic or acute oxidative stress, including atherosclerotic plaques.
The examiner notes that the prior art teaches administration of the claimed API to a subject to prevent and treat atherosclerosis, atherosclerotic plaques and other cardiovascular conditions. Linton teaches treating and preventing atherosclerosis and plaque buildup, heart attack, stroke, and other cardiovascular conditions and events by controlling reactive aldehydes, including malondialdehyde (MDA), isoketals and neuroketals. See Abstract. Even further, the instant Specification notes that a wide dosage range will be safe and effective.
The examiner notes, that it is not necessary that a POSA understood each mechanism or any mechanism by which prevention and/or treatment occurs. Rather, it is proper that the claimed agent is taught for administration as a result-effective variable or component to a subject with a claimed symptom or condition. A person of ordinary skill in the art would optimize the dosage the claimed components and it would be expected to have an effect that is claimed when optimized. According to M.P.E.P. § 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
In this case, the examiner is not alleging inherency. He is noting that the claimed active steps and those taught by multiple prior art references are substantially similar if not identical. Further, Linton even teaches controlling malondialdehydes in an effort to treat a claimed subject. Additionally, 2-HOBA is taught to protect against oxidative stress. As such, the burden has shifted to Applicant to explain and show for the record that the claimed result of reducing dilysyl-MDA would not result from the routine optimization of a dosage of 2-HOBA when treating those subjects taught by the prior art to be treated.
The examiner’s same logic applies to the other obviousness rejections set forth on the record. If the claimed agent is taught to be administered to a claimed subject, there is a reasonable expectation of success that treatment will result. Moreover, the claimed agent is a known result-effective variable and/or component thereof that would be optimized through northing more than routine experimentation to arrive at a desired and optimal effect. It is not necessary for prior art to describe or even understand a specific mechanism by which treatment occurs. Multiple references in addition to Linton teach administration of a composition comprising 2-HOBA to a claimed subject.
For these reasons the § 103 rejections and Double Patenting Rejections are maintained.
Applicant can overcome the obviousness rejections by showing that the claimed dosage is not optimizable and/or was not obvious to arrive at in view of Linton. Without a showing of unexpected results, the examiner is determining if a prima facie showing is established in view of the cited prior art. For the reasons set forth above and below, he concludes that a prima facie showing of obviousness is set forth by the cited prior art.
Status of the Claims
Claims 1-11 are pending and examined.
Claim Rejections - 35 USC § 102/§103
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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by, or in the alternative, obvious under § 103(a) over Linton et al., (WO2018/201074A1) (cited in IDS).
Linton teaches treating preventing and treating atherosclerosis by administering 2-HOBA. Such administration also reduced LDL levels and atherosclerotic lesions. See p1. Further, 2-HOBA rapidly reacts with IsoLG and MDA. See p7, 1st par. MDA-LDL levels were decreased with 2-HOBA treatment. See p8. Treatment also decreased the development of atherosclerosis in hypercholesterolemic mice. Further treatment was used on familial hypercholesterolemia. See Figures 1A-1E and 6A. The API, including 2-HOBA, can be used in combination with other drugs that are therapeutically active. Lipid peroxidation is known to accelerate the pathogenesis of atherosclerosis and cardiovascular events.
As such, the claimed agents are taught to treat the claimed subject population and the claimed effects are described. As such, the claimed steps are taught and/or immediately envisaged in view of the teachings of the prior art as a whole.
Alternatively, Linton teaches treating and preventing atherosclerosis and plaque buildup, heart attack, stroke, and other cardiovascular conditions and events by controlling reactive aldehydes, including malondialdehyde (MDA), isoketals and neuroketals. See Abstract.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods in view of Linton. One would be motivated to do so because the claimed API is taught for administration to a same subject population and, while not necessary to establish a prima facie showing, is taught to control reactive aldehydes including malondialdehyde, in an effort in “treating and preventing atherosclerosis or plaque buildup in arteries, the underlying cause of heart attack, stroke and peripheral vascular disease, and more specifically treating and preventing the development of atherosclerosis and cardiovascular events….” Thus, a POSA would understand that such administration would achieve a treatment of the same and/or would be optimized through nothing more than routine experimentation of a single known result-effective variable for achieving the same. As such and in view of the strength of the prior art, such claims are anticipated and/or obvious. The instant Specification indicates that the compounds are safe and effective over a wide dose range. See par. 97.
As such, claims 1-11 are anticipated by, or obvious over, the cited prior art.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fabjan et al., “Tartary Buckwheat (Fagopyrum tartaricum Gaertn.) as a Source of Dietary Rutin and Quercetin,” Journal of Agricultural and Food Chemistry 2003, in view of Cheng, (US2016/0136224), as evidenced by Market Insider “Lost Superfood Now Rejuvenated: Big Bold Health® Produces First Certified Organic Commercial Crop of Himalayan Tartary Buckwheat in US,” December 2, 2020, and in view of Salvamani et al., Antiartherosclerotic Effects of Plant Flavonoids,” Biomedical Research International Volume 2014.
Fabjan teaches tartary buckwheat grain has high rutin and other flavonoids. It is “well established” that rutin antagonizes the increase in capillary fragility associated with hemorrhagic disease, reduces high blood pressure, decreased blood vessel permeability, has antiedema effects, reduces risk of arteriosclerosis, and shows antioxidant activity. See p6452, 3rd par.
Cheng teaches compositions for lowering lipids. See Abstract. Further, experimental data shows Camellia nitidissima can reduce LDL-C levels of serum in hyperlipidemic mice substantially. See par. 4. Further, plants containing lipid-lowering and hypoglycemic active components include tartary buckwheat. See par. 24 and prior art claim 10.
As evidenced by Market Insider, Vanderbilt Dr. Naji Abumrad teaches tartary buckwheat (Fagopyrum tataricum) comprises 2-HOBA.
With regard to claim 8, the reduction of MDA- and IsoG-lysyl appears to be product/result of the administration of the claimed agent to the claimed subject at an optimized dosage.
With regard to claim 10, tartary buckwheat comprise rutin in addition to 2-HOBA.
Rutin is taught by Salvamani to have antiatherosclerotic effects. See Abstract. Rutin is taught to “play a great role in preventing atherosclerosis and the evidence for its antiatherosclerotic effects is available in in vivo studies.” See p3, 2nd par. Further, Salvamani teaches:
Voskresensky and Bobyrev showed that rutin delays the hypercholesterolemia development and inhibits the atherosclerotic formation in rabbits’ aorta. While, Santos et al. researched into the effects of rutin on controlling lipid metabolism and found that rutin reduced the cholesterol levels and has the lowest level of triacylglycerol in hypercholesterolemia rats.
It would have been prima facie obvious to a POSA prior to the filing of the instant application to administer a composition comprising 2-HOBA to prevent or treat a condition, including capillary fragility associated with hemorrhagic disease, high blood pressure, decreased blood vessel permeability, edema, and those at risk of arteriosclerosis. Further, administering a claimed agent to a subject would prevent such conditions if a subject is capable of having a claimed condition. As such, there is a reasonable and predictable expectation of success in arriving at the claimed method in view of the teachings of the cited prior art. Further, tartary buckwheat is taught to treat and prevent hyperlipidemia and cardiovascular disease/atherosclerosis. Rutin qualifies as an agent that has an effect of treating atherosclerosis, e.g. As such, it would be prima facie obvious with a reasonable expectation of success to administer the claimed agent to a claimed subject in view of the explicit teachings and recognition in the art of the effective nature of multiple compounds in tartary buckwheat, including 2-HOBA and rutin. Thus, if a subject that atherosclerosis or hypercholesterolemia and/or any combination thereof, it would be obvious to administer a claimed agent as it is capable and treating and preventing each condition.
Moreover, it is not necessary that a POSA understood each mechanism or any mechanism by which prevention and/or treatment occurs. Rather, it is proper that the claimed agent is taught for administration as a result-effective variable or component to a subject with a claimed symptom or condition. A person of ordinary skill in the art would optimize the dosage the claimed components and it would be expected to have an effect that is claimed when optimized. According to M.P.E.P. § 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
In this case, the examiner is not alleging inherency. He is noting that the claimed active steps and those taught by multiple prior art references are substantially similar if not identical. As such, the burden has shifted to Applicant to explain and show for the record that the claimed result of reducing dilysyl-MDA would not result from the routine optimization of a dosage of 2-HOBA when treating those subjects taught by the prior art to be treated.
Claims 1-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hou J CN109601990 A, as evidenced by Market Insider “Lost Superfood Now Rejuvenated: Big Bold Health® Produces First Certified Organic Commercial Crop of Himalayan Tartary Buckwheat in US,” December 2, 2020, and in view of Salvamani et al., Antiartherosclerotic Effects of Plant Flavonoids,” Biomedical Research International Volume 2014, as evidenced by Wang et al., Tartary buckwheat rutin: Accumulation, metabolic pathways, regulation mechanisms, and biofortification strategies, Plant Physiology and Biochemistry Volume 208, March 2024.
Hou teaches a food preparation comprising 22-26% tartary buckwheat for treating and preventing hyperlipidemia and cardiovascular disease. See “Advantage.”
As evidenced by Market Insider, Vanderbilt Dr. Naji Abumrad teaches tartary buckwheat (Fagopyrum tataricum) comprises 2-HOBA.
With regard to claim 8, the reduction of MDA- and IsoG-lysyl appears to be product/result of the administration of the claimed agent to the claimed subject at an optimized dosage.
With regard to claim 10, tartary buckwheat comprises rutin in addition to 2-HOBA. As evidenced by Wang et al., tartary buckwheat is the only food crop with high rutin content (RC) in whole-plant. See p1, 2nd par. “At present, the rutin content (RC) is regarded as the key index for evaluating the nutritional quality of tartary buckwheat.” Abstract.
Rutin is taught by Salvamani to have antiatherosclerotic effects. See Abstract. Rutin is taught to “play a great role in preventing atherosclerosis and the evidence for its antiatherosclerotic effects is available in in vivo studies.” See p3, 2nd par. Further, Salvamani teaches:
Voskresensky and Bobyrev showed that rutin delays the hypercholesterolemia development and inhibits the atherosclerotic formation in rabbits’ aorta. While, Santos et al. researched into the effects of rutin on controlling lipid metabolism and found that rutin reduced the cholesterol levels and has the lowest level of triacylglycerol in hypercholesterolemia rats.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods in view of the cited prior art. One would be motivated to administer tartary buckwheat, which includes 2-HOBA as well as rutin which is known to inhibit and delay hypercholesteremia and atherosclerosis. Further, tartary buckwheat is taught to treat and prevent hyperlipidemia and cardiovascular disease/atherosclerosis. Rutin qualifies as an agent that has an effect of treating atherosclerosis, e.g. As such, it would be prima facie obvious with a reasonable expectation of success to administer the claimed agent to a claimed subject in view of the explicit teachings and recognition in the art of the effective nature of multiple compounds in tartary buckwheat, including 2-HOBA and rutin. Thus, if a subject that atherosclerosis or hypercholesterolemia and/or any combination thereof, it would be obvious to administer a claimed agent as it is capable and treating and preventing each condition.
Moreover, it is not necessary that a POSA understood each mechanism or any mechanism by which prevention and/or treatment occurs. Rather, it is proper that the claimed agent is taught for administration as a result-effective variable or component to a subject with a claimed symptom or condition. A person of ordinary skill in the art would optimize the dosage the claimed components and it would be expected to have an effect that is claimed when optimized. According to M.P.E.P. § 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
In this case, the examiner is not alleging inherency. He is noting that the claimed active steps and those taught by multiple prior art references are substantially similar if not identical. As such, the burden has shifted to Applicant to explain and show for the record that the claimed result of reducing dilysyl-MDA would not result from the routine optimization of a dosage of 2-HOBA when treating those subjects taught by the prior art to be treated.
Claims 1-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chen A, CN 106806635 A, as evidenced by Market Insider “Lost Superfood Now Rejuvenated: Big Bold Health® Produces First Certified Organic Commercial Crop of Himalayan Tartary Buckwheat in US,” December 2, 2020, and in view of Salvamani et al., Antiartherosclerotic Effects of Plant Flavonoids,” Biomedical Research International Volume 2014, as evidenced by Wang et al., Tartary buckwheat rutin: Accumulation, metabolic pathways, regulation mechanisms, and biofortification strategies, Plant Physiology and Biochemistry Volume 208, March 2024.
Chen teaches an oral liquid comprising 10-50 parts tartary buckwheat for treating and preventing angina pectoris, hyperlipidemia, and atherosclerosis. See “Use.” It is taught as an oral liquid formulation.
As evidenced by Market Insider, Vanderbilt Dr. Naji Abumrad teaches tartary buckwheat (Fagopyrum tataricum) comprises 2-HOBA.
With regard to claim 8, the reduction of MDA- and IsoG-lysyl appears to be product/result of the administration of the claimed agent to the claimed subject at an optimized dosage.
With regard to claim 10, tartary buckwheat comprises rutin in addition to 2-HOBA. As evidenced by Wang et al., tartary buckwheat is the only food crop with high rutin content (RC) in whole-plant. See p1, 2nd par. “At present, the rutin content (RC) is regarded as the key index for evaluating the nutritional quality of tartary buckwheat.” Abstract.
Rutin is taught by Salvamani to have antiatherosclerotic effects. See Abstract. Rutin is taught to “play a great role in preventing atherosclerosis and the evidence for its antiatherosclerotic effects is available in in vivo studies.” See p3, 2nd par. Further, Salvamani teaches:
Voskresensky and Bobyrev showed that rutin delays the hypercholesterolemia development and inhibits the atherosclerotic formation in rabbits’ aorta. While, Santos et al. researched into the effects of rutin on controlling lipid metabolism and found that rutin reduced the cholesterol levels and has the lowest level of triacylglycerol in hypercholesterolemia rats.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods in view of the cited prior art. One would be motivated to administer tartary buckwheat, which includes 2-HOBA as well as rutin which is known to inhibit and delay hypercholesteremia and atherosclerosis. Further, tartary buckwheat is taught to treat and prevent hyperlipidemia and cardiovascular disease/atherosclerosis. Rutin qualifies as an agent that has an effect of treating atherosclerosis, e.g. As such, it would be prima facie obvious with a reasonable expectation of success to administer the claimed agent to a claimed subject in view of the explicit teachings and recognition in the art of the effective nature of multiple compounds in tartary buckwheat, including 2-HOBA and rutin. Thus, if a subject that atherosclerosis or hypercholesterolemia and/or any combination thereof, it would be obvious to administer a claimed agent as it is capable and treating and preventing each condition.
Moreover, it is not necessary that a POSA understood each mechanism or any mechanism by which prevention and/or treatment occurs. Rather, it is proper that the claimed agent is taught for administration as a result-effective variable or component to a subject with a claimed symptom or condition. A person of ordinary skill in the art would optimize the dosage the claimed components and it would be expected to have an effect that is claimed when optimized. According to M.P.E.P. § 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
In this case, the examiner is not alleging inherency. He is noting that the claimed active steps and those taught by multiple prior art references are substantially similar if not identical. As such, the burden has shifted to Applicant to explain and show for the record that the claimed result of reducing dilysyl-MDA would not result from the routine optimization of a dosage of 2-HOBA when treating those subjects taught by the prior art to be treated.
Claims 1-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wang, CN 102742767 A, as evidenced by Market Insider “Lost Superfood Now Rejuvenated: Big Bold Health® Produces First Certified Organic Commercial Crop of Himalayan Tartary Buckwheat in US,” December 2, 2020, and in view of Salvamani et al., Antiartherosclerotic Effects of Plant Flavonoids,” Biomedical Research International Volume 2014, as evidenced by Wang et al., Tartary buckwheat rutin: Accumulation, metabolic pathways, regulation mechanisms, and biofortification strategies, Plant Physiology and Biochemistry Volume 208, March 2024.
Wang teaches a compositions comprising Fagopyrun tataricum for treating hyperlipidemia, coronary heart disease, and myocardial infarction. See “Use” section.
As evidenced by Market Insider, Vanderbilt Dr. Naji Abumrad teaches tartary buckwheat (Fagopyrum tataricum) comprises 2-HOBA.
With regard to claim 8, the reduction of MDA- and IsoG-lysyl appears to be product/result of the administration of the claimed agent to the claimed subject at an optimized dosage.
With regard to claim 10, tartary buckwheat comprise rutin in addition to 2-HOBA. As evidenced by Wang et al., tartary buckwheat is the only food crop with high rutin content (RC) in whole-plant. See p1, 2nd par. “At present, the rutin content (RC) is regarded as the key index for evaluating the nutritional quality of tartary buckwheat.” Abstract.
Rutin is taught by Salvamani to have antiatherosclerotic effects. See Abstract. Rutin is taught to “play a great role in preventing atherosclerosis and the evidence for its antiatherosclerotic effects is available in in vivo studies.” See p3, 2nd par. Further, Salvamani teaches:
Voskresensky and Bobyrev showed that rutin delays the hypercholesterolemia development and inhibits the atherosclerotic formation in rabbits’ aorta. While, Santos et al. researched into the effects of rutin on controlling lipid metabolism and found that rutin reduced the cholesterol levels and has the lowest level of triacylglycerol in hypercholesterolemia rats.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods in view of the cited prior art. One would be motivated to administer tartary buckwheat, which includes 2-HOBA as well as rutin which is known to inhibit and delay hypercholesteremia and atherosclerosis. Further, tartary buckwheat is taught to treat and prevent hyperlipidemia and cardiovascular disease/atherosclerosis. Rutin qualifies as an agent that has an effect of treating atherosclerosis, e.g. As such, it would be prima facie obvious with a reasonable expectation of success to administer the claimed agent to a claimed subject in view of the explicit teachings and recognition in the art of the effective nature of multiple compounds in tartary buckwheat, including 2-HOBA and rutin. Thus, if a subject that atherosclerosis or hypercholesterolemia and/or any combination thereof, it would be obvious to administer a claimed agent as it is capable and treating and preventing each condition.
Moreover, it is not necessary that a POSA understood each mechanism or any mechanism by which prevention and/or treatment occurs. Rather, it is proper that the claimed agent is taught for administration as a result-effective variable or component to a subject with a claimed symptom or condition. A person of ordinary skill in the art would optimize the dosage the claimed components and it would be expected to have an effect that is claimed when optimized. According to M.P.E.P. § 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
In this case, the examiner is not alleging inherency. He is noting that the claimed active steps and those taught by multiple prior art references are substantially similar if not identical. As such, the burden has shifted to Applicant to explain and show for the record that the claimed result of reducing dilysyl-MDA would not result from the routine optimization of a dosage of 2-HOBA when treating those subjects taught by the prior art to be treated.
As such, no claim is allowed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5 of U.S. Pat. No. 11,389,414. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘414 patent are directed to “attenuating atherosclerosis” by administering 2-HOBA. The instant claims include administration of the same agent to a subject with atherosclerosis whether or not it is secondary to and/or concomitant with hypercholesterolemia.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Pat. No. 11,633,370. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘370 patent are directed to slowing the progression of an age-related oxidant injury by administering 2-HOBA. See claims 1 and 3. Further, the meaning of age-related includes cardiovascular diseases. Applicant’s Remarks herein note that the claimed damage/result is a process that occurs in tissues undergoing chronic or acute oxidative stress, including atherosclerotic plaques. The instant claims include administration of the same agent to a subject with atherosclerosis whether or not it is secondary to and/or concomitant with hypercholesterolemia.
As such, no claim is allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628