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 .
Status of the Claims
Claims 1-2 and 4-8 are pending in this application. Claims 3 and 9-10 have been cancelled by applicant.
Claim Objections
Claim 2 is objected to because of the following informalities:
The claim reads: “wherein the Panduratin A and Pinostrobin is . . .” Claim should read: “wherein the Panduratin A and Pinostrobin are . . .”
Appropriate correction is required.
Claim Interpretation
Regarding claim 2, the terms “physically coupled” or “chemically coupled” have not been defined in the specification. “Chemically coupled” will be broadly interpreted as covalently bonded or electrostatically bonded; while “physically coupled” will be interpreted as any form of physical contact, including heterogenous and homogenous mixing. The claim has been given the broadest reasonable interpretation (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
Claim Rejections - 35 USC § 103
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.
Claims 1 and 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Eng-Chong et al. (Evidence-Based Complementary and Alternative Medicine, 2012, Article ID 473637, 25 pages – previously cited); and Chin Tan et al. (Evidence-Based Complementary and Alternative Medicine, 2015, Article ID 451870, 7 pages – previously cited); in view of Atakisi et al. (Eur. Rev. Med. Pharmacol. Sci., 2009, 13, 425-429).
Regarding claims 1 and 4, applicant is advised that a recitation of the intended use of the claimed invention, such as the use of the Panduratin A and Pinostrobin composition for the treatment of coronavirus infections/ inhibition of coronavirus replication, as recited in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02.
Regarding claims 1 and 4-8, Eng-Chong discloses the fresh rhizomes of the Boesenbergia rotunda have been used as antiparasitic agents to eradicate helminth or round worms in human intestine (page 2, col. 2, section 1.2, lines 16-17) and that the B. rotunda extracts have been used as antiparasitics (Table 2, entry 3, page 9; and page 8, para. bridging col. 1-2) (thus reading on application of the composition as a medicament). Eng-Chong also discloses the antioxidant activity of the rhizomes of this plant, particularly disclosing Panduratin A and Pinostrobin as antioxidants (Table 2, entry 6, page 9; and page 12, col. 1-2, sections 7 and 8)
While Eng-Chong does not specifically teach a molar ratio of 1:4 to 1:10 or administration with ivermectin, the teachings of Chin Tan and Atakisi et al. are relied upon for these disclosures.
Chin Tan teaches Panduratin A and Pinostrobin exist as bioactive metabolites in the rhizomes of the Boesenbergia rotunda plant (page 1, col. 1, para. 2) in a ratio of 1: 26.5 (Table 1, page 5) (molar ratio of about 1: 40 – calculated with MW of 428.6 g/mol for Panduratin A, MW of 270.28 g/mol for Pinostrobin, and with the relative concentration values provided in Table 1).
Atakisi teaches ivermectin as an antiparasitic agent that is safe for administration to mammals (reading on use as medicament), however, to a lesser extent, has a detrimental effect on the oxidant/ antioxidant balance (abstract – conclusion).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to prepare a composition comprising Panduratin A, Pinostrobin, and ivermectin, as a medicament, as recited in instant claims 1 and 8. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Eng-Chong’s teachings that fresh rhizomes of the Boesenbergia rotunda have been used as antiparasitic agents to eradicate helminth or round worms in human intestine, and that Panduratin A and Pinostrobin, taught by Chin Tan to be major components found in the rhizomes of the Boesenbergia rotunda (see Figure 2), also have antioxidant properties; further in view of Atakisi’s teachings that ivermectin is safe as an antiparasitic agent, though may offset oxidant/ antioxidant balance, thus suggesting additional benefits of co-administration with antioxidants Panduratin A and Pinostrobin.
Thus, with respect to a mixture of the two claimed reagents, the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose (antiparasitics in the preset case), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).” See MPEP2144.06. It is therefore obvious to provide a mixture of the claimed agents.
Regarding the claimed molar ratio range of 1:4 to 1:10 for Panduratin A and Pinostrobin, as recited in claim 1, applicant is advised, In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph).
In the instant case, the plant extract (presumably with a 1: 40 molar ratio of Panduratin A and Pinostrobin) is believed to exhibit the same properties as the instantly claimed range.
Further regarding claims 5-7, Chin Tan teaches Panduratin A and Pinostrobin exist as bioactive metabolites in the rhizomes of the Boesenbergia rotunda plant (page 1, col. 1, para. 2).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Eng-Chong et al. (Evidence-Based Complementary and Alternative Medicine, 2012, Article ID 473637, 25 pages – previously cited); and Chin Tan et al. (Evidence-Based Complementary and Alternative Medicine, 2015, Article ID 451870, 7 pages – previously cited); in view of Atakisi et al. (Eur. Rev. Med. Pharmacol. Sci., 2009, 13, 425-429); as applied to claims 1 and 4-8; further in view of Hwang et al. (US 2019/0070129 A1 – previously cited).
The teachings of Eng-Chong, Chin Tan, and Atakisi et al. are disclosed above and incorporated herein.
While Eng-Chong and Chin Tan in view of Atakisi et al. do not teach a pharmaceutical composition further comprising a carrier; the teachings of Hwang et al. are relied upon for these disclosures.
Hwang discloses a pharmaceutical composition comprising Panduratin A and an oxidant stabilizer (reading on Pinostrobin) (Hwang’s claim 5). Hwang teaches their Panduratin A composition comprising additive ingredients, like sugars etc. (reading on physically coupled carriers – see claim interpretation) [0093].
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to prepare a composition comprising Panduratin A, Pinostrobin, ivermectin, and a carrier, such as flavoring agents or sugars, as taught by Hwang. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Eng-Chong, Chin Tan, and Atakisi’s teaching of an antiparasitic composition comprising Panduratin A, Pinostrobin, and Ivermectin; further in view of Hwang’s teachings of a Panduratin A composition for oral administration comprising sugars and flavoring agents as carriers, designed to make oral administration more palatable.
Response to Arguments
Claims/ Claim Objections
Claim amendments are acknowledged. No new matter has been added.
Applicant’s arguments, see page 3, filed October 15th, 2025, with respect to objections of claims 3 and 10 have been fully considered and are persuasive. Claims 3 and 10 have been cancelled, thus rendering the objection moot. Claim objections are hereby withdrawn.
Claim Rejections - 35 USC § 112(b)
Applicant’s arguments, see page 3, filed October 15th, 2025, with respect to 35 USC § 112(b) rejections of claims 2 and 9-10 have been fully considered and are persuasive. Claims 9-10 have been cancelled, thus rendering the objection moot. Claim 2 has been amended to solve indefiniteness. 35 USC § 112(b) rejections are hereby withdrawn.
Claim Rejections - 35 USC § 101
Applicant’s arguments, see pages 3-4, filed October 15th, 2025, with respect to 35 USC § 101 rejections of claims 1-2 and 4-10 have been fully considered and are persuasive. 35 USC § 101 rejections are hereby withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see pages 4-5, filed October 15th, 2025, with respect to the rejections of claims 1-10 under 35 USC § 103 have been fully considered and are persuasive. Claims 3 and 9-10 have been cancelled, rendering the rejection moot. The rejection of claims 1-2 and 4-8 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Eng-Chong, Chin Tan, and Atakisi et al., for claims 1 and 4-8, and Eng-Chong, Chin Tan, Atakisi, and Hwang et al., for claim 2. See above.
Applicant states Hwang Tan and Eng-Chong fail to teach or suggest a Panduratin A and Pinostrobin composition in a molar ratio of 1:4 – 1:10, further comprising an antiviral agent such as ivermectin.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding the molar ratio of the individual natural products, Chin Tan teaches Panduratin A and Pinostrobin exist as bioactive metabolites in the rhizomes of the Boesenbergia rotunda plant (page 1, col. 1, para. 2) in a ratio of 1: 26.5 (Table 1, page 5) (molar ratio of about 1: 40), thus the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on.”
Regarding the teaching of a composition further comprising ivermectin, as stated above, Atakisi teaches ivermectin as an antiparasitic agent that is safe for administration to mammals (reading on use as medicament). Since Panduratin A and Pinastrobin are known to have antiparasitic properties, then, in the absence evidence of unexpected results, Applicant is reminded the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose (antiparasitics in the preset case), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.
Applicant’s arguments rely on language solely recited in preamble recitations in instant claims. When reading the preamble in the context of the entire claim, the recitation “capable of inhibiting replication of coronavirus in a subject upon administration in an effective amount to the subject” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Conclusion
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.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627