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 .
Election/Restrictions
Applicant’s election of Sulphurenic acid as the elected compound species and pulmonary fibrosis as the elected indication species in the reply filed on 08/19/2025 is maintained.
Priority
This application is the National Phase of PCT International Application No. PCT/US2021/033221, filed on May 19, 2021, which claims priority under 35 U.S.C. 119(e) to U.S. Provisional Application No. 63/027,029, filed on May 19, 2020.
Claims Status
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on December 05, 2025. Claims 1 and 6-11 are pending. Claims 2-5 and 12-13 are canceled. Claims 1, 6 and 8-10 are withdrawn. Claims 7 and 11 are examined in accordance to the elected species.
Action Summary
The objection to claim 7 is withdrawn in light of the amendment to claim 7.
Claim 7 rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives, is withdrawn in light of the claim amendment deleting preventing.
Claims 7 and 11 rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al (WO2021/102124 A1) in view of Comeglio et al (Journal of Steroid Biochemistry & Molecular Biology 168 (2017) 26–37), Day (Antioxid Redox Signal. 2008 February; 10(2): 355–370), and Wu et al (US2016/0318972A1), are maintained, but modified and revisited in light of the claim amendment.
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.
Claims 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al (WO2021/102124 A1) in view of Comeglio et al (Journal of Steroid Biochemistry & Molecular Biology 168 (2017) 26–37), Day (Antioxid Redox Signal. 2008 February; 10(2): 355–370), and Wu et al (US2016/0318972A1).
This rejection is based to the extent compound XII of Cheng is sulphurenic acid.
Cheng teaches a method of treating at least one disease or disorder in a subject in need thereof, wherein the disease is fibrosis, the method comprising:
administering to the subject a therapeutically effective amount of an extract comprising at least one selective Farnesoid X receptor (FXR) agonist obtained from Antrodia cinnamomea (Antrodia camphorate), and
enhancing or inducing FXR mediated transcriptional response in the subject, wherein the at least one FXR agonist is a triterpenoid compound and wherein the triterpenoid compound is compound (VI)
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. which is dehydrosulphurenic acid and the compound (XII) which is sulphurenic acid
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. (See claims 1-5, Fig. 3, and page 3.)
Cheng does not teach pulmonary fibrosis as the elected fibrotic condition.
Comeglio teaches FXR activation has also been demonstrated to suppress the inflammatory response and to promote lung repair after lung injury. This study investigated the protective effects of OCA treatment (3 or 10 mg/kg/day) on inflammation, tissue remodeling and fibrosis in the bleomycin-induced pulmonary fibrosis rat model. (See Abstract.) Moreover, Cormglio teaches the significant reduction of pulmonary fibrosis and interstitial remodeling by OCA may lead to effective improvement of lung function in bleomycin-treated rats, as indicated by the reduced lung resistance to inflation. Indeed, rats treated with bleomycin exhibited a severe increase in pressure at airway opening, with FXR activation by OCA significantly improving it to an extent similar to pirfenidone. (See the third paragraph of the left column of page 36.)
It would have been prima facie obvious to one ordinary skill in the art at the time the invention was filed to modify the method taught by Cheng to include pulmonary fibrosis to give Applicant’s claimed method. One would have been motivated to do so, not only because Cheng teaches compound XII which is sulphurenic acid as an FXR agonist that can be used for treating fibrosis, but also because Comeglio teaches FXR activation or agonist can be used for treating pulmonary fibrosis. One would reasonably expect success by using the method taught by Cheng to treat pulmonary fibrosis.
Day teaches numerous studies have shown oxidative stress to be associated with many interstitial lung diseases and that these agents are effective in attenuating fibroproliferative responses in the lung of animals and humans. (See Abstract.)
Wu teaches a method of preparing an extract of (AC) Antrodia Cinnamomea (aka Antrodia Camphorate) using the fruit body comprising ergostane and/or lanostate triterpenoid compound. (See Abstract and paragraph [0010].). Moreover, Wu teaches the product of the AC extract have been reported to have anti-oxidant anti-hypersensitive and immunostimulatory effects. (See paragraph [0004].) The lanostate triterpenoid compounds that are obtained from the fruit body AC extract include
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. (See paragraph [0034].)
Dehydrosulphurenic acid Sulphurenic acid
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It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to use the sulphurenic acid as compound XII taught by Cheng for treating pulmonary fibrosis by reducing or inhibiting oxidative stress to give Applicant’s claimed invention. One would have been motivated to do so with a reasonable expectation of success that because sulphurenic acid is taught by Wu to have antioxidative stress property and oxidative stress is implicated in pulmonary fibrosis as taught by Dey. One would reasonably expect sulphurenic acid to treat pulmonary fibrosis due to its antioxidative property with success.
Acknowledgement is made of the receipt and entry of Applicant’s remarks/arguments filed on December 05, 2025.
Applicant argues that as amended, claim 7 is directed solely to the therapeutic use of sulphurenic acid for treating fibrotic conditions. None of the cited references teach or suggest using sulphurenic acid for treating fibrosis. The newly presented limitation fundamentally changes the scope of the claim and eliminates any overlap with the cited combinations of Cheng, Comeglio, Day, and Wu. The references cited by the Examiner do not disclose, suggest, or motivate the use of sulphurenic acid as a treatment for fibrotic conditions, nor do they suggest the presently claimed method after the amendments. The prior art therefore fails to teach the amended claim as required for a prima facie case of obviousness.
In response, Applicant’s argument is not persuasive. The newly presented limitation may fundamentally change the scope of the claim and eliminates any overlap with the cited combinations of Cheng, Comeglio, Day, and Wu. However, the references cited by the Examiner do disclose, suggest, or motivate the use of sulphurenic acid as a treatment for pulmonary fibrosis as the elected fibrotic condition based on the modified rejection above and the new rejection below.
New Rejection necessitated by claim amendment
Claims 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al (WO2021/102124 A1) in view of Comeglio et al (Journal of Steroid Biochemistry & Molecular Biology 168 (2017) 26–37), Day (Antioxid Redox Signal. 2008 February; 10(2): 355–370), and Wu et al (US2016/0318972A1).
This rejection is based to the extent compound XII of Cheng is not sulphurenic acid.
Cheng teaches a method of treating at least one disease or disorder in a subject in need thereof, wherein the disease is fibrosis, the method comprising:
administering to the subject a therapeutically effective amount of an extract comprising at least one selective Farnesoid X receptor (FXR) agonist obtained from Antrodia cinnamomea (Antrodia camphorate), and
enhancing or inducing FXR mediated transcriptional response in the subject, wherein the at least one FXR agonist is a triterpenoid compound and wherein the triterpenoid compound is compound (VI)
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. which is dehydrosulphurenic. (See claims 1-5, Fig. 3, and page 3.)
Cheng does not teach pulmonary fibrosis as the elected fibrotic condition. Additionally, Cheng does not teach sulphurenic acid
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.
Comeglio teaches FXR activation has also been demonstrated to suppress the inflammatory response and to promote lung repair after lung injury. This study investigated the protective effects of OCA treatment (3 or 10 mg/kg/day) on inflammation, tissue remodeling and fibrosis in the bleomycin-induced pulmonary fibrosis rat model. (See Abstract.) Moreover, Cormglio teaches the significant reduction of pulmonary fibrosis and interstitial remodeling by OCA may lead to effective improvement of lung function in bleomycin-treated rats, as indicated by the reduced lung resistance to inflation. Indeed, rats treated with bleomycin exhibited a severe increase in pressure at airway opening, with FXR activation by OCA significantly improving it to an extent similar to pirfenidone. (See the third paragraph of the left column of page 36.)
It would have been prima facie obvious to one ordinary skill in the art at the time the invention was filed to substitute compound XII of Chen with sulphurenic acid taught by Wu because both would be expected to have FXR agonistic activity as both are isomers of each other.
Compound XII of Cheng and sulphurenic acid
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are structurally the same compound.. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and in re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195. One would be motivated to make such substitution because both compounds are expected to have FXR activation or agonistic property that can be used to treat pulmonary fibrosis. One would reasonably expect the substitution to treat pulmonary fibrosis with success by activating FXR.
Day teaches numerous studies have shown oxidative stress to be associated with many interstitial lung diseases and that these agents are effective in attenuating fibroproliferative responses in the lung of animals and humans. (See Abstract.)
Wu teaches a method of preparing an extract of (AC) Antrodia Cinnamomea (aka Antrodia Camphorate) using the fruit body comprising ergostane and/or lanostate triterpenoid compound. (See Abstract and paragraph [0010].). Moreover, Wu teaches the product of the AC extract have been reported to have anti-oxidant anti-hypersensitive and immunostimulatory effects. (See paragraph [0004].) The lanostate triterpenoid compounds that are obtained from the fruit body AC extract include
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. (See paragraph [0034].)
Dehydrosulphurenic acid Sulphurenic acid
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It would have been prima facie obvious as well to one of ordinary skill in the art at the time the invention was filed to replace or compound XII acid taught by Cheng with the sulphurenic acid taught by Wu to give Applicant’s claimed invention. One would have been motivated to do so with a reasonable expectation of success that both compounds will have similar activities because dehydrosulphurenic acid and sulphurenic acid are structurally similar. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195. One would also be motivated to make such substitution because both compounds ae expected to have antioxidant properties s taught by Wu that can be used to treat pulmonary (lung) fibrosis as taught by Dey. One would reasonably expect the substitution to treat pulmonary fibrosis with success by upregulating antioxidant defense mechanisms.
Conclusion
Claims 7 and 11 are not allowed.
THIS ACTION IS MADE FINAL. 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 JEAN P CORNET whose telephone number is (571)270-7669. The examiner can normally be reached Monday-Thursday from 7.00am-5.30pm.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628
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