DETAILED ACTION
A non-final Office action was mailed on 1 June 2021 (“Office Action”).
A Notice of Abandonment was mailed on 8 February 2022.
Applicant filed a petition to revive the application along with a reply to the Office Action on 28 February 2022 (“Reply”).
A Petition Decision granting the petition was mailed on 23 March 2026.
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 1–6 and 10–16 are pending.
Claims 1, 10, and 16 are amended.
Claims 7–9 are canceled.
Applicant must delete the text of any canceled claim.
Status of Rejections and Objections
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Claim Rejections - 35 U.S.C. § 102
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.
Claim 16 is rejected under 35 U.S.C. § 102(a)(1) as being anticipated by CN101747338 (“Yu”) [IDS] as disclosed in a Google Patents machine translation.
Claim 16 is directed to: “Total ginkgolide prepared by a preparation method . . .”
The claim recites method steps but does not define structural features of total ginkgolide.
Claim 16 is a product-by-process claim.
The MPEP explains the patentability of a product-by-process claim is determined by the product itself and does not depend on the method of production:
“[E]ven 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).
(MPEP § 2113).
Yu discloses total ginkgolide. (Yu, Abstract). Yu anticipates claim 16.
Response to Arguments
Applicant’s arguments submitted with the Reply have been fully considered but are not persuasive. Applicant does not dispute that Yu discloses total ginkgolide. Applicant argues the previously cited references (Yu, Wang, Lou, Qin) do not disclose the features recited in the method steps in claim 16. (Remarks, pp.6–7). This argument is not persuasive because the patentability of a product-by-process claim is determined by the product and does not depend on the method of production. (MPEP § 2113).
Claim Rejections - 35 U.S.C. § 101
35 U.S.C. § 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Subject matter eligibility for patentability is determined by evaluating the claimed invention in accordance with the flowchart in MPEP § 2106(III). Step 1 asks whether the claims are directed to one of the four categories of statutory subject matter (process, machine, manufacture, or composition of matter). Step 2 is a two-part test to determine if the claims are directed to a judicial exception (Step 2A); and whether additional elements of the claim provide an inventive concept encompassing significantly more than the judicial exception (Step 2B).
Claim 16 is a product-by-process claim. As noted above, the patentability of a product-by-process claim is determined by the product itself and does not depend on the method of production.
Claim 16 is rejected under 35 U.S.C. § 101 because the claimed invention recites a judicial exception (e.g., law of nature, natural phenomenon, abstract idea) (Step 2A) without including significantly more (Step 2B). For the reasons below, the claimed invention, considered as a whole, is not directed to subject matter that is eligible for patentability.
The product is a composition of matter, which is one of the four enumerated statutory categories under 35 U.S.C. § 101. Because claim 16 falls within a statutory category, it requires further analysis to determine whether it is drawn to a judicial exception. (Step 1: YES).
Claim 16 is directed to total ginkgolide, which represents a natural product obtained in a process that isolates and purifies the total ginkgolide from an extract of ginkgo biloba. When a claim recites a natural product limitation, a markedly different characteristics (MDC) analysis is used to determine whether the natural product has markedly different characteristics from its natural counterpart.
The first step in the MDC analysis requires selecting the appropriate counterpart. When the natural product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. In this case, the total ginkgolide is compared to the total ginkgolide in its natural state, i.e., the ginkgo biloba tree or extract.
The second step in the MDC analysis requires selecting an appropriate characteristic for analysis. Appropriate characteristics can be expressed as the natural product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis. In this case, the appropriate characteristics are the structure and function of the total ginkgolide.
The third step in the MDC analysis requires comparing the characteristics of the claimed natural product to its naturally occurring counterpart in its natural state—to determine whether the characteristics of the claimed product are markedly different. In this case, the structure and function of the total ginkgolide are compared to that of the same total ginkgolide within the ginkgo biloba tree or extract. Because there is no indication in the record that isolation and purification of total ginkgolide results in a marked difference in structure, function, or other properties as compared to its natural counterpart, the claimed total ginkgolide is a product of nature exception. (Step 2a, prong one: YES).
Claim 16 is directed to total ginkgolide. With respect to additional elements, the claim may be interpreted either as containing no additional elements beyond the total ginkgolide or as containing an additional limitation of isolation and purification. Regardless, the claim is drawn to total ginkgolide. Accordingly, the claims do not recite additional elements that integrate the total ginkgolide into a practical application. (Step 2a, prong two: NO).
Furthermore, with respect to prong two, there are no additional elements required beyond the total ginkgolide, or the fact the total ginkgolide is isolated and purified is an additional element. If there are no additional elements, then the claim does not recite any meaningful limitations that transform the total ginkgolide into significantly more than the total ginkgolide itself. If the isolation and purification can be considered an additional element, then the additional element represents well-understood, routine, and conventional activity. The process elements in claim 16 include mixing, precipitating, dissolving, centrifuging, purifying, and recrystallizing—each of which are conventional activity in the art. For example, US 6,030,621 (“De Long”) summarizes several prior art processes of isolating and purifying total ginkgolide or a specific component thereof that involve mixing, precipitating, dissolving, purifying, and recrystallizing. (De Long, at 1:14–6:22) (col:line). De Long further discloses its own examples of isolating and purifying total ginkgolide or a specific component thereof. (Id., 11:61–14:14). For example, US 5,089,636 (“Kwak”) discloses mixing ginkgo biloba extract powder with an alkaline solution, dissolving the resulting solid in a lower alcohol, and adding an aqueous solution of lead acetate thereto; or, in the alternative, dissolving the ginkgo biloba extract powder in an organic solvent, adding water, and centrifuging the solution to obtain a residue that can recrystallized. (Kwak, 2:15–3:48). Based on the typically high education level of workers in the organic chemistry art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience. One of ordinary skill in the art would consider the steps of isolating and purifying total ginkgolide and the associated activities involved therein to represent well-understood, routine, and conventional activity that does not transform the claim into significantly more than the total ginkgolide.
Therefore, claim 16 is not patent eligible.
Allowable Subject Matter
Claims 1–6 and 10–15 are allowed. Claim 1 is an independent claim and claims 2–6 and 10–15 depend directly or indirectly from claim 1. Claim 1 requires mixing a ginkgo biloba extract powder with an alkali solution, dissolving a solid resulting from the mixing, and centrifuging the solid to obtain a precipitate. The mixing, dissolving, and centrifuging activities are disclosed in Kwak but not in the claimed order. Furthermore, claim 1 requires purifying the total ginkgolide solid obtained from centrifuging via column chromatography using multistep eluent sequence with a dichloromethane/methanol solution as the eluent. None of the cited references disclose or suggest the multistep eluent sequence with a dichloromethane and methanol solution as the eluent.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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/J.M.N./Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
