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
Claims 1-12 are pending. Claims 1, 4,-6,8-11 are examined herein on the merits. Claim 12 is withdrawn.
Claim Rejections - 35 USC § 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.
Claims 1, 4, 6, 8, 9, 10 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. The claimed invention is directed to non-statutory subject matter because the claimed invention is directed to a naturally-occurring product, whether isolated or not, that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., -- U.S. -- (June 13, 2013).
An invention is not patent eligible subject matter when:
(a) the claimed invention does not fall within at least one of the four categories of patent eligible subject matter recited in 35 U.S.C. 101 (process, machine, manufacture, or composition of matter); or
(b) the claimed invention, although nominally falling within at least one of the four eligible categories, is directed to a judicial exception to 35 U.S.C. 101 (i.e., an abstract idea, natural phenomenon, or law of nature); or
(c) the claimed invention would impermissibly cover every substantial practical application of, and thereby preempt all use of, an abstract idea, natural phenomenon, or law of nature; or (d) the claimed invention is directed to a naturally-occurring product, whether isolated or not, that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., -- U.S. -- (June 13, 2013). See MPEP 2106, MPEP 706.03(a).
Based upon an analysis with respect to the claims as a whole, the claims do not recite something significantly different than a naturally occurring product, namely Artemisia carvifolia extract which contains artemisinin, chlorophyll, chlorogenic acid, Artemisia carvifolia acid, coumarin, artemisia ketone ketone, stigmasterol, phytosterol, D - (+) - camphor (D - (+) -Camphor), beta-sweetacacia ([beta] Farnesene), zeta-elemene. See BAI (CN 102232473 A reference used in the below rejection. Moreover, the claim recites two naturally occurring compounds with any additional elements to amount to significantly more.
Regarding the product-by process recitation, note MPEP 2113: "[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 instant case the claims are directed to artemisinin and chlorogenic acid. The process of isolating and obtaining the two naturally occurring exceptions do not change the judicial exceptions themselves. The mere isolation of naturally occurring exceptions from the natural environment without any further alteration does not render the components patent eligible.
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 (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 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.
1) Claims 1, 4, 5, 6, 8, 9, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ZHENGZHOU ZHANGMENG NETWORK TECH CO LTD (CN 106727886 A, 2017, PTO-892; used English Machine translation).
ZHENGZHOU ZHANGMENG discloses drug for treating liver cancer, the drug is composed of in parts by weight: 13-21 parts of astragalus, 15-25 parts of chlorogenic acid, 1-5 parts of caraway ketone, and 7-15 parts of artemisinin; the drug is composed of 15-19 parts of astragalus, 18-22 parts of chlorogenic acid, 2-4 parts of caraway ketone, and 9-13 parts of artemisinin; the drug is composed of the following raw materials in parts by weight: 17 parts of astragalus, 20 parts of chlorogenic acid, 3 parts of caraway ketone, and 11 parts of artemisinin (meets the molar ratio in claim 5). See claims 1-3.
Regarding the product-by process limitations recited, note MPEP 2113: "[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 instant case the claims are directed to artemisinin and chlorogenic acid. Thus, the product claimed appears to be the same and since it is unclear what the process limitation impart, the burden is shifted to applicant.
ZHENGZHOU ZHANGMENG anticipates instant claims.
2)Claims 1, 4, 6, 8, 9, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BAI (CN 102232473 A, 2011, PTO-892; used English Machine translation).
BAI teaches that Artemisia carvifolia extract is applied to feed industry as the animal feed additive. Artemisia carvifolia extract contains artemisinin, chlorophyll, chlorogenic acid, Artemisia carvifolia acid, coumarin, artemisia ketone ketone, stigmasterol, phytosterol, D - (+) - camphor (D - (+) -Camphor), beta-sweetacacia ([beta] Farnesene), zeta-elemene and other plant physiology active material pharmaceutical composition. See claim 1.
Regarding the product-by process limitations recited, note MPEP 2113: "[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 instant case the claims are directed to artemisinin and chlorogenic acid. Thus, the product claimed appears to be the same and since it is unclear what the process limitation impart, the burden is shifted to applicant.
BAI anticipates instant claims.
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 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.
3) Claims 5, 11 are rejected under 35 U.S.C. 103 as being unpatentable over BAI (CN 102232473 A, PTO-892; used English Machine translation) as applied to claims 1, 2, 4, 6-8, 9, 10 above, and further in view of Marcela María Salazar Murillo (MethodsX 5 (2018) 83–89, PTO-892).
BAI is applied as discussed above.
BAI does not teach employment of starch in the animal feed composition therein.
Marcela María Salazar Murillo teaches that starch is an important nutrient in animal feed. See abstract.
It would have been obvious to a person of ordinary skill in the art to employ starch in the animal feed composition because 1) BAI teaches that Artemisia carvifolia extract containing artemisinin, chlorophyll, chlorogenic acid is applied to feed industry as the animal feed additive; and 2) Marcela María Salazar Murillo teaches that starch is an important nutrient in animal feed. It would have been obvious to a person of ordinary skill in the art to employ starch in the animal feed composition comprising artemisinin, chlorogenic acid with reasonable expectation of success of obtaining the animal feed composition with desired nutrition.
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.
1)Claims 1, 4, 5, 6, 8-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 6, 7-9, 13, 15, 16, 17 of co-pending Application No. 17/928,858 (reference application), in view of (CN 102232473 A, PTO-892; used English Machine translation), and further in view of Marcela María Salazar Murillo (MethodsX 5 (2018) 83–89, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are drawn to a composition comprising a) artemisinin and b) at least one chlorogenic acid; wherein the molar ratio between the compound or the compounds present in the combination is between 2 and 0.002.
Claims of ‘858 are drawn to a composition comprising at least one compound having at least one 1,2,4-trioxane moiety or a combination of a) at least one compound having at least one 1,2,4-trioxane moiety and b) at least one chlorogenic acid; wherein the molar ratio between the compound or the compounds having at least one 1,2,4-trioxane moiety and the chlorogenic acid or chlorogenic acids present in the combination is between 2 and 0.002; wherein the compounds comprising at least one 1,2,4-trioxane moiety are obtained via extraction of Artemisia annua.
It would have been obvious to a person of ordinary skill in the art to obtain instant composition because ‘858 teaches a composition comprising at least one compound having at least one 1,2,4-trioxane moiety or a combination of a) at least one compound having at least one 1,2,4-trioxane moiety and b) at least one chlorogenic acid; wherein the molar ratio between the compound or the compounds having at least one 1,2,4-trioxane moiety and the chlorogenic acid or chlorogenic acids present in the combination is between 2 and 0.002 wherein (a) may be artemisinin.
It would have been obvious to a person of ordinary skill in the art to employ starch in the composition taught by ‘858 because 1) BAI teaches that the composition containing artemisinin, chlorogenic acid is applied to feed industry as the animal feed additive; and 2) Marcela María Salazar Murillo teaches that starch is an important nutrient in animal feed. It would have been obvious to a person of ordinary skill in the art to employ starch in the composition comprising artemisinin, chlorogenic acid with reasonable expectation of success of obtaining the animal feed composition with desired nutrition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2)Claims 1, 4, 5, 6, 8-9, 10, 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of co-pending Application No. 19/079,342 (reference application), in view of (CN 102232473 A, PTO-892; used English Machine translation), and further in view of Marcela María Salazar Murillo (MethodsX 5 (2018) 83–89, PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are drawn to a composition comprising a) artemisinin and b) at least one chlorogenic acid; wherein the molar ratio between the compound or the compounds having at least one 1,2,4-trioxane moiety and the chlorogenic acid or chlorogenic acids present in the combination is between 2 and 0.002.
Claims of ‘342 are drawn to a composition comprising a) at least artemisinin and b) at least one chlorogenic acid; wherein the molar ratio between artemisinin and the chlorogenic acid or chlorogenic acids present in the combination is between 2 and 0.002; wherein the compounds comprising at least one 1,2,4-trioxane moiety are obtained via extraction of Artemisia annua.
It would have been obvious to a person of ordinary skill in the art to obtain instant composition because ‘342 teaches a composition comprising a) at least artemisinin and b) at least one chlorogenic acid; wherein the molar ratio between artemisinin and the chlorogenic acid or chlorogenic acids present in the combination is between 2 and 0.002.
It would have been obvious to a person of ordinary skill in the art to employ starch in the composition taught by ‘342 because 1) BAI teaches that the composition containing artemisinin, chlorogenic acid is applied to feed industry as the animal feed additive; and 2) Marcela María Salazar Murillo teaches that starch is an important nutrient in animal feed. It would have been obvious to a person of ordinary skill in the art to employ starch in the composition comprising artemisinin, chlorogenic acid with reasonable expectation of success of obtaining the animal feed composition with desired nutrition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 2/23/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims are patent eligible since the extraction of artemisinin with tea or coffee does not occur in nature. Applicant argues that although Artemisia annua might contain both artemisinin and chlorogenic acid, it does not contain many components that are present in coffee - e.g. caffeine, trigonelline, cafestol, kahweol, and melanoidins.
First it is noted that the claims are directed to a composition comprising artemisinin and chlorogenic acid. The product by process limitation recited is “wherein the at least one chlorogenic acid is obtained by extraction of coffee and/or tea; or wherein the composition is obtained via co-extraction of Artemisia annua and coffee and/or tea with water.” Thus the broadest embodiment claimed is a composition comprising artemisinin and chlorogenic acid with the product by process limitation recited “wherein the at least one chlorogenic acid is obtained by extraction of coffee and/or tea.
Thus, applicant’s argument is unpersuasive since the claims are directed to a product, i.e. a composition that comprises two naturally occurring components, artemisinin and chlorogenic acid. The method of obtaining or isolating the naturally occurring compounds does not alter the compounds themselves. Regarding applicant’s arguments that Artemisia does not contain components that are present in coffee - e.g. caffeine, trigonelline, cafestol, kahweol, and melanoidins is not persuasive. Again the claim is directed to artemisinin and chlorogenic acid. Not artemisinin, chlorogenic acid, caffeine, trigonelline, cafestol, kahweol, and melanoidins. If applicant is contending that the process limitations impart a different structure to the product claimed of (a) artemisinin and (b) chlorogenic acid then applicant must provide evidence.
Note MPEP 2113: "[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." Once a product appearing substantially identical is found, the burden shifts to applicant to show the unobvious difference. "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product.
Applicant has not provided any evidence. Moreover it is noted that the claiming of individually isolated components is not patent eligible unless evidence is given that the exception has changed from what occurs in nature. For instance, the mere isolation of artemisinin and chlorogenic acid from its natural environment without any further alteration does not render the components patent eligible.
Even if arguendo if applicant is arguing that the second embodiment process limitation recited “wherein the composition is obtained via co-extraction of Artemisia annua and coffee and/or tea with water” would contain the components of coffee or tea , i.e. caffeine, trigonelline, cafestol, kahweol, and melanoidins, first it is pointed out that applicant uses the term “or” and thus only one of the process limitations needs to be met. Thus, the broadest reasonable embodiment is either the process of obtaining the least one chlorogenic acid is obtained by extraction of coffee and/or tea; or the composition is obtained via co-extraction of Artemisia annua and coffee and/or tea with water. Assuming arguendo even if the composition contains, other naturally containing components such as caffeine, etc, claiming naturally occurring components together without evidence that the naturally occurring exceptions interact in a manner with markedly different characteristics does not make the claims patent eligible.
Applicant arguments pertaining to the prior art rejections is similar to the arguments presented in response to the 101 rejection. Thus, the above response is incorporated herein. Again it is noted that the claims are directed to a composition comprising artemisinin and chlorogenic acid. The product by process limitation recited is “wherein the at least one chlorogenic acid is obtained by extraction of coffee and/or tea; or wherein the composition is obtained via co-extraction of Artemisia annua and coffee and/or tea with water.” Thus the broadest embodiment claimed is a composition comprising artemisinin and chlorogenic acid and the product by process limitation recited is “wherein the at least one chlorogenic acid is obtained by extraction of coffee and/or tea.”
Applicant has not provided any evidence that the product by process limitations impart a structural difference in particular to the process limitation “the at least one chlorogenic acid is obtained by extraction of coffee and/or tea.” Moreover, regarding the second embodiment claimed in which the composition is extracted with coffee/tea, since applicant only claims the composition contains chlorogenic acid artemisinin, thus the composition is structurally claimed as chlorogenic acid and artemisinin. Thus, obtaining this composition with the extraction of tea or coffee is examined according to MPEP 2113. Applicant does not claim any components of tea or coffee. Thus, it is assumed these are removed during the extraction process to merely isolate chlorogenic acid artemisinin since the composition only contains chlorogenic acid artemisinin. It is suggested that applicant either clearly define what the composition contains or provide evidence per MPEP 2113.
Regarding the obviousness-type double patenting rejections, applicant defers arguments until allowable subject matter is identified. Therefore, the rejections are maintained.
Prior Art made of Record:
CN 105853776; veterinary antiviral injection contains mangiferin, chlorogenic acid, flavone, artemisinin and immune material, used for preventing and curing disease of each kind of livestock viral disease;
CN 105343332.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARMILA G. LANDAU whose telephone number is (571)272-0614. The examiner can normally be reached Monday-Friday 6-3:30.
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/SHARMILA G LANDAU/
Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights