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.
Election/Restrictions
Applicant’s election of Group I claims 1-11 without traverse, and 1, 2, 4-trioxane artemisinin compound of Formula (IV) as the species in the reply filed on 08/06/2025 is acknowledged.
Claims 3, 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species.
Claims 1, 2, 4-11 are examined herein on the merits so far as they read on the elected species.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2, page 4/8 recites for R2 “wherein the carbonyl groups together with the oxygen bound to the residue R1 form a carboxylic ester”. It should recite “wherein the carbonyl groups together with the oxygen bound to the residue R2 form a carboxylic ester”. Appropriate correction is required.
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, 2, 4, 6, 7, 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, claims 1, 2, 4, 6, 7, 8, 9, 10 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. Therefore, claims 1, 2, 4, 6, 7, 8, 9, 10 are rejected as not being directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4, 5-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “1,2,4-trioxane moiety”, in claim 1 is vague and indefinite. This term is not clearly defined in the specification, it is not clear what compounds this term encompasses, since one of ordinary skill in the art could not ascertain the metes and bounds as to “1,2,4-trioxane moiety”. It is pointed out that one of skill in the art would recognize that ”moiety” is merely a part of a molecule or a compound. One of ordinary skill in the art would recognize there are various and numerous 1,2 4-trioxane containing compounds whose structures are widely varying, and one of ordinary skill in the art could not ascertain the metes and bounds as to “1,2,4-trioxane moiety”.
Claims 5, 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The recitation “preferably between 0.8 and 0.005, more preferably between 0.5 and 0.01 and even more preferably 0.1 and 0.01” in claim 5 renders the scope of the claims unclear.
The recitation “preferably a 40 °C to 100 °C” in claim 8 renders the scope of the claims unclear.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The recitations n is an integer of more than 1, “preferably 2 to 10, more preferably 2, 3 or 4 and even more preferably 2 or 3” in claim 2 renders the scope of the claims unclear.
The recitation “R1 is a residue that is n times substitued by the residue depicted in the rounded bracket, and is preferably C1-Cis-alkyl or ….” in claim 2 renders the scope of the claims unclear.
The recitation “in particular” in claim 2 is unclear which renders the scope of the claim unclear.
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, 2, 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.
ZHENGZHOU ZHANGMENG anticipates instant claims.
2)Claims 1, 2, 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.
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, 2, 4, 5, 6-9, 10, 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) 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 thechlorogenic acid or chlorogenic acids 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.
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, 2, 4, 5, 6-9, 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) 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.
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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHOBHA KANTAMNENI, Ph.D whose telephone number is (571)272-2930. The examiner can normally be reached on Monday to Friday; 8.00 am-4.30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel, Ph.D can be reached on 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHOBHA KANTAMNENI/Primary Examiner, Art Unit 1627
Prosecution Insights