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 .
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Korea on 09 March 2023 and 27 Jun 2023.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
No Information Disclosure Statement has been filed.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [00108] states “FIG. 5”, but refers to the results in FIG. 6
Paragraph [00139] states “FIG. 3”, but refers to the results in FIG. 13
Appropriate correction is required.
Claim Status
Claims examined: 1-14
Claims rejected: 1-3, 6-8, 11-14
Claims objected to: 4, 5, 9, 10
Claim Objections
Claim 11 objected to because of the following informalities:
States “The composition of 6,”, should state “The composition of claim 6,”
. Appropriate correction is required.
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.
Claims 1-3, 6-8, and 11-14 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12263154. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of Claim 1-3 in the present application, are compounds comprising catechol and 4’6,7-trimethoxyisoflavone disclosed in claim 1 of the U.S. Patent.
Claim 1 in the present application discloses a compound described as a flavone derivative of Formula 4, see below. R1-R4 substituents can be hydrogen, a hydroxy group, a methyl group, or a methoxy group.
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The compounds of Formula 1 and Formula 2 in the US patent can be seen below.
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Claim 1 in the US patent discloses a compound comprising a mixture of 4′,6,7-trimethoxyisoflavone and catechol. R1 and R2 in the present application correspond to the two hydroxy groups on 1,2-dihydroxybenzene (catechol) in the US patent, R3 in the present application corresponds to a hydrogen on catechol in the US patent, and R4 in the present application corresponds to the methoxy group on 4′,6,7-trimethoxyisoflavone in the US patent.
Claim 2 in the present application discloses a compound described as a flavone derivative of Formula 4, see above, wherein R1 is hydrogen or a hydroxy group, R2 is a hydroxy or methoxy group, R3 is a hydrogen, methoxy group, or hydroxy group, and R4 is a methoxy group. R1 and R2 in the present application correspond to the two hydroxy groups on 1,2-dihydroxybenzene (catechol) in the US patent, R3 in the present application corresponds to a hydrogen on catechol in the US patent, and R4 in the present application corresponds to the methoxy group on 4′,6,7-trimethoxyisoflavone in the US patent. The compounds disclosed in the US patent disclose the limitations of claim 2 in the present application.
Claim 3 in the present application discloses a compound described as a flavone derivative of Formula 4, see above, wherein R1 and R2 in the present application correspond to the two hydroxy groups on catechol in the US patent, R3 in the present application corresponds to a hydrogen on catechol in the US patent, and R4 in the present application corresponds to the methoxy group on 4′,6,7-trimethoxyisoflavone in the US patent.
It would have been obvious to one of ordinary skill in the art to chemically combine the active ingredients, 4′,6,7-trimethoxyisoflavone and catechol to create a compound of Formula 4, with all the limitations of claims 1-3 in the present application, because the patent discloses a mixture of the two compounds and the broadest reasonable interpretation of a mixture of two compounds is a formulated single compound.
Claim 6 in the present application discloses a composition used for improving pulmonary fibrosis. The composition comprises Formula 4, see the written rejection above for the compound of Claim 1 of the present application.
Claim 7 in the present application discloses a specific composition of claim 6, used for improving pulmonary fibrosis. See the written explanation above for the compound disclosed in Claim 2 of the present application.
Claim 8 in the present application discloses a specific composition of claim 6, used for improving pulmonary fibrosis. See the written explanation above for the compound disclosed in Claim 3 of the present application.
Claim 1 in the US patent discloses a method for managing pulmonary fibrosis comprising a mixture of 4′,6,7-trimethoxyisoflavone and catechol. The present application and the US Patent document both disclose compositions for improving pulmonary fibrosis.
It would have been obvious for one of ordinary skill in the art to combine the two compounds disclosed in Claim 1 of the US patent and method of use for managing pulmonary fibrosis to create a compound of Formula 4 in the present application because they are both used for treatment of pulmonary fibrosis, and the compounds disclosed in the US patent, if combined would produce the compositions of Claims 6-8 with the same intended use. Claim 1 in the US patent describes a mixture of the two compounds for use in managing pulmonary fibrosis and the broadest reasonable of a mixture of two compounds, includes a formulated single compound.
Claim 11 comprises the composition for improving pulmonary fibrosis of claim 6, and specifies the pulmonary fibrosis as idiopathic pulmonary fibrosis in the present application. In the US Patent, Pulmonary fibrosis includes idiopathic pulmonary fibrosis (Page 11, Background, line 24-25).
Claim 12 comprises the composition for improving pulmonary fibrosis of claim 6, and specifies the composition as pharmaceutical in the present application. In the US Patent, claim 2 discloses the method of claim 1 comprising managing pulmonary fibrosis with a composition comprising a mixture of 4′,6,7-trimethoxyisoflavone and catechol, and specifies the composition is a pharmaceutical composition.
Claim 13 comprises the composition for improving pulmonary fibrosis of claim 6, and specifies the composition as a food composition. In the US Patent, claim 3 discloses the method of claim 1 comprising managing pulmonary fibrosis with a composition comprising a mixture of 4′,6,7-trimethoxyisoflavone and catechol, and specifies the composition as a food composition.
Claim 14 the present application discloses a method of treatment described as administering a flavone derivative of Formula 4, see above, used for improving pulmonary fibrosis. In the US Patent, claim 1 discloses a method of treatment managing pulmonary fibrosis with a composition comprising a mixture of 4′,6,7-trimethoxyisoflavone and catechol.
It would have been obvious for one of ordinary skill in the art to include the treatment of idiopathic pulmonary fibrosis in the US patent, because it was disclosed in the specification, and therefore encompass all the limitations of Claim 11.
It would have been obvious for one of ordinary skill in the art to use the method of Claim 1 in the US patent as a pharmaceutical composition, to encompass all the limitations of Claim 12 in the claimed application because they are clearly disclosed.
It would have been obvious for one of ordinary skill in the art to use the method of Claim 1 in the US patent as a food composition, to encompass all the limitations of Claim 13 in the claimed application because they are clearly disclosed.
It would have been obvious for one of ordinary skill in the art to combine the two compounds disclosed in Claim 1 of the US patent and method of use for managing pulmonary fibrosis to create a compound of Formula 4 in the present application because they are both used for treatment of pulmonary fibrosis, and the compounds disclosed in the US patent, if combined would produce the compounds of Claim 14 with the same intended use. Claim 1 in the US patent describes a mixture of the two compounds for use in managing pulmonary fibrosis and the broadest reasonable of a mixture of two compounds, includes a formulated single compound.
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.
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.
Claim 1, 6, and 11-14 are rejected under 35 U.S.C. 103 as being obvious over Cui (Xiu-ling Cui, Jie Ren, Chao Pi, and Yang-jie Wu, “An Aryl Heterocyclic Derivative and Synthesis Method Thereof”, Foreign Patent Application No. CN 113956208 A, Pub. Date 1/21/2022).
Regarding Claim 1, Cui teaches an aryl heterocyclic derivative for medicinal use, compound I-25 (Specification, Pg. 17, [0177]), shown bottom left, which overlaps with the instantly claimed Formula 4, shown bottom right. According to Claim 1, R1-R4 can be hydrogen, hydroxy, methyl, or methoxy groups. To map I-25 with Formula 4, R1 is hydrogen, R2 is a methoxy group, R3 is hydrogen, and R4 is hydrogen.
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Cui does not teach compound I-25 with only 2 methoxy substituents on the benzene ring.
Cui does teach that position R9 has variable attachment points, see below, and can be methoxy or hydrogen, but does not specify how many attachment points are required (Claim 1, and Specification pg. 3).
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Regarding Claim 6, 11-14, Cui teaches compound I-25, an aryl heterocyclic derivative for use in the “field of medicine” (Abstract and pg. 17 [0177]). Cui does not teach that I-25 is a flavone, is used to treat idiopathic pulmonary fibrosis, a pharmaceutical composition, a food composition, or a method of treatment comprising administering to a subject a flavone derivative of Formula 4.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have a reasonable expectation for success for the compound disclosed in Claim 1 of the present application, by only adding 2 methoxy groups at position R9 in Cui’s compound Het-g, instead of 4, because both compounds are used therapeutically. Also, because Cui’s composition is used medicinally, the broadest reasonable interpretation, would include carrying out the intended use as a method for improving idiopathic pulmonary fibrosis in a pharmaceutical/food composition.
Allowable Subject Matter
Claims 4 and 5 are objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 9 and 10 are objected to as being dependent upon a rejected base claim 6, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIERRA M ROCHELLE whose telephone number is (571)272-9962. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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