DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The previous claim rejection made under 35 U.S.C. 103 over Yu et al. (CN111297942 A) in view of Zhang et al. (CN1421239 A) and Lange et al. (US 20090111826 A1) as indicated in the Office action dated November 20, 2025 is maintained for reasons of record.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yu et al. (CN111297942 A, published on June 19, 2020, cited in IDS) (“Yu” hereunder) in view of Zhang et al. (CN1421239 A, published on June 4, 2004, cited in IDS) (“Zhang” hereunder) and Lange et al. (US 20090111826 A1, published on April 30, 2009) (“Lange” hereunder).
The present claim 1 is directed to a pharmaceutical composition for treating myocardial ischemia, comprising Salvia miltiorrhiza medicinal material in an amount of 250-700 parts by weight, Radix Notoginseng medicinal material in an amount of 50-150 parts by weight, Borneolum Syntheticum in an amount of 3-9 parts by weight, and ranolazine in an amount of 25-100 parts by weight. Based on 100 parts of the composition, the weight ratio of Salvia miltiorrhiza: Notoginseng: Borneol: ranolazine is about 76.2-73.0: 15.2-15.6: 0.9: 7.6 -10.4.
Yu discloses a pharmaceutical preparation for treating myocardial ischemia and relieving pain, promoting blood circulation, etc., the composition comprising ranolazine and a mixture comprising Salvia miltiorrhiza, Panax Notoginseng and Borneol. See translation, abstract. The composition comprises 20-50 part of ranolazine, 20-50 parts of a mixture consisting of Salvia miltiorrhiza, Panax Notoginseng and Borneol, 5-30 parts of a diluent, 5-20 parts of a disintegrating agent, 1-10 parts of an adhesive, 0.1-1 part of a pH regulator and 0.5-2 parts of a lubricant. See translation, p. 3, bridging paragraph. The reference teaches that combining the mixture of medicinal plant materials with ranolazine enables reducing the dose and the cost of the chemical drug See translation, p. 4, last paragraph.
Yu fails to teach the ratio of Salvia miltiorrhiza, Panax Notoginseng and borneol.
Zhang teaches a preparation for treating cardiac and cerebral vascular diseases, the composition comprising a red sage (Salvia miltiorrhiza) extract in 4-60 wt %, Radix Notoginseng extract 2-18 wt% and Borneol Syntheticum 1-10 wt %. See translation, abstract. The reference teaches that the composition resists myocardial ischemia, treats coronary heart disease, angina (chest pain), myocardial infarction, cerebral thrombus and other diseases. See Id. The reference teaches that Salvia miltiorrhiza promotes blood circulating, removes blood statis, nourishes blood and calms the mind, etc; the main contents of the plant include fat-soluble diterpenes, water-soluble phenolic acids, flavonoids, triterpenes, and sterols. See translation, p. 2.
Given the teaching of the mixture of Salvia miltiorrhiza extract, Radix Notoginseng extract and Borneol in treating myocardial ischemia, one of ordinary skill in the art before the effective filing date of the present application would have obviously motivated to look to prior art such as Zhang for further teachings on suitable proportions of the medicinal plant extracts in the mixture. Since Zhang discloses such proportion of the same medicinal plant extracts used in Yu, which is also used for the same purposes of treating myocardial ischemia, coronary heart disease, angina, etc., the skilled artisan would have adopted such teaching in formulating the Yu composition.
Although the proportion of ranolazine in the Yu formulation is higher than that of the present claims, lowering the dosage of a drug for patients having adverse reaction or according to needs is a conventional practice in medicine. See Lange, [0127]. As Yu also suggests that reduction of the amount of ranolazine is desirable and Zhang teaches that Salvia miltiorrhiza, Notoginseng and Borneol alone can be used to treat cardiac and cerebral vascular diseases, one of ordinary skill in the art would have been obviously motivated to find an optimal low dosage of ranolazine to formulate a safe pharmaceutical composition to treat myocardial ischemia. See the present claims 1 and 12.
Claims 2-7 are product-by-process claims. It is well known in patent law that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.) See also MPEP 2113. In this case, Yu in view of Zhang teaches and suggests using water extract, ethanol extracts or water extract-alcohol precipitation extract of the same medicinal plants to prepare pharmaceutical composition useful for the same purposes of treating myocardial ischemia; no patentable distinction is seen between the mixture of Salvia miltiorrhiza, Radix Notoginseng and Borneol extracts which are prepared according to the teachings of Yu or Zhang from the product of the present claims 2-7.
Regarding claims 8-11, both Yu and Zhang teach that their compositions can be prepared as capsules, tablets, granules, etc. See Yu, translation, p. 5 step four; Zhang, translation, p. 4, third full paragraph. The reference teach formulations can further comprise a diluent, disintegrant, a binder, etc; including such excipients to make pharmaceutical dosage forms suitable for oral administration would have been prima facie obvious.
Response to Arguments
Applicant's arguments filed on January 23, 2026 have been fully considered but they are not persuasive.
Applicant argues that the Zhang teaching is limited to the use of extracts rather than “as medicinal materials (i.e., herbs)”. In response, the examiner respectfully points out that the use of Salvia miltiorrhiza, Radix Notoginseng, Borneolum Syntheticum as medicinal materials is plainly disclosed in the primary reference, Yu. Zhang was cited to show why one of ordinary skill in the art before the effective filing date of the present application would have been motivated to use the herbs of Yu in the ratio of the present claims. Applicant argues that the extracts of Zhang are different from the present composition, but the examiner respectfully points out that the extract components must be present in the plant materials from which the extracts are obtained. One of ordinary skill in the art would have been obviously motivated to use the teaching regarding the ratio of Salvia miltiorrhiza: Radix Notoginseng; Borneolum Syntheticum extracts as disclosed in Zhang in modifying the Yu composition comprising the medicinal materials and obtain the benefit of Salvia miltiorrhiza which imparts blood circulation, removes blood statis and nourishes blood and calms the mind etc.
In response to applicant’s argument that there is no motivation to lower the amount of ranolazine, the rejection specifically cited Lange which teaches to lower dose of a drug for patients having adverse reactions or as the need decreases. The rejection also cites 1) Yu which suggests that reduction of the amount of ranolazine is desirable and 2) Zhang which suggests that Salvia miltiorrhiza, Notoginseng and Borneol alone can be used to treat cardiac and cerebral vascular diseases. There is no explanation or response to these specific rationales to lower the amount of ranolazine indicated in the rejection.
Conclusion
No claims are allowed.
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 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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/GINA C JUSTICE/Primary Examiner, Art Unit 1617
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