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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 3rd, 2026 has been entered.
All previous objections and rejections not reiterated herein were overcome by claim amendments and arguments, filed March 3rd, 2026 have been fully considered and found persuasive. As such all objections and rejections not reiterated herein have been withdrawn.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Canadian Patent Application CA 2929001 A1 to Yoo et. al. (herein after Yoo’001; cited in the office action dated April 7th, 2025) in view of Park et. al. ((2010), Glabridin inhibits Lipopolysaccharide-induced Activation of a Microglial Cell Line, BV-2, by Blocking NF-kB and AP-1, Phytother. Res., 24, 29 – 34).
Yoo’001 teach pyranochromenyl phenol derivatives and pharmaceutical compositions comprising said derivatives for treating inflammatory disease (abstract). Yoo’001 teach glabridin is known to have anti-inflammatory effect but is chemically unstable since it can be broken down by sunlight, moisture, acidity, basicity, oxygen, and heat (page 3 paragraph 0007). Additionally Yoo’001 teach compounds of Formula (I)
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(claim 5) which encompasses both the (R) and (S) configuration of the Formula (claims 7 – 10) (page 5 paragraph 0023). More specifically, Yoo’001 teach compound 4
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(claims 6 and 8) (page 9 paragraph 0061), compound 5
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(claims 6 and 10) (page 9 paragraph 0061), and compound 15
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(claims 6 and 10) (page 16 paragraph 00116). Furthermore, Yoo’001 teach that in example 6 Table 7 that both compounds 4, 5, and 15 exhibited similar anti-inflammatory IC50 values in RAW264.7 macrophages with 8.6 µM, 5.2 µM, and 6.8 µM values respectively as compared to glabridin IC50 of 9.3 µM (page 70 paragraph 00603). Moreover, Yoo’001 teach in the chemical stability test that both compounds 4, 5, and 15 had significantly improved stability as compared to Glabridin after 72 hrs. in both acidic (page 71 paragraph 00608 Table 8 ) and basic conditions (page 71 paragraph 00609 Table 9).
Regarding claim 5, recitation wherein the method comprises increasing the activity of Paraoxonase 1 and Paraoxonase 2 in the subject, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. (MPEP 2112.01). The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product. Thus, even though Yoo’001 directs to methods for treating inflammatory disease, since the prior art reference of Yoo’001 teach identical compounds to the instant application; these compounds necessarily increase the activity of Paraoxonase 1 and Paraoxonase 2.
Regarding claims 7 – 10, as mentioned above, Yoo’001 teach compounds of Formula (I)
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(claim 5) which encompasses both the (R) and (S) configuration of the Formula (claims 7 – 10) (page 5 paragraph 0023). Additionally, Yoo’001 teach the generic reference Formula I of structure
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which is identical to instant Formula (III)
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(page 5 paragraph 0023) that includes instant Formula IV and instant Formula V which only differ by the orientation of the H. This H bond represents the only stereocenter in the molecule of instant Formula (III)
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with instant Formula IV
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(claims 7 – 8) and instant Formula V
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(claims 9 – 10) representing the only two stereo configurations possible for the H, outside of the R1-6 groups.
Thus given that instant Formula III encompasses instant Formula IV and instant Formula V, and given that both instant Formula IV and instant Formula V represent the only two orientations the H can be instant Formulas III-V represent stereoisomers of each other. Therefore, as stereoisomers 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) (MPEP2144.09).
However, Yoo’001 fail to teach a method for preventing or treating a neurological disease wherein the neurological disease is Parkinson’s disease (claim 5).
Nevertheless, Park et. al. teach that neuroinflammation is implicated in the pathogenesis of various neurodegenerative diseases, such as Alzheimer’s diseases, Parkinson’s diseases, multiple sclerosis and AIDS dementia (page 29 column 1 paragraph 1). Park et. al. teach that microglia, innate immune cells resident in the brain, have been thought to play a role in host defense and tissue repair in the central nervous system (CNS) (page 29 column 1 paragraph 1). Furthermore, Park et. al. teach that recent reports suggested that microglia are major cells responsible for inflammation-mediated neurotoxicity (page 29 column 1 paragraph 1). Moreover, Park et. al. teach that it has been suggested that activation of microglia and subsequent release of inflammatory mediators, such as nitric oxide (NO), tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β), might contribute to neuronal injuries and/or neurodegenerative processes (page 29 column 1 paragraph 1). Additionally, Park et. al. teach that glabridin inhibits the production of NO, TNF-α and IL-1β in LPS stimulated BV-2 microglial cells and this is mediated, at least in part, by blocking NF-κB and AP-1 activation (page 33 column 2 paragraph 3).
Therefore, it would have been obvious before the effective filing date of the instant application to use the chemically stable glabridin derivatives of Yoo’001, that is prior art compounds 4, 5, and 15 in methods of treating inflammatory disorders in view of Park et. al. that is in a method of treating Parkinson’s disease. One of ordinary skill in the art would have been motivated to make this modification to mitigate microglia the innate immune cells resident in the brain. One of ordinary skill in the art would have had a reasonable expectation of success because glabridin a chemically similar compound to prior art compounds 4, 5, and 15, inhibited the production of NO, TNF-α and IL-1β in LPS stimulated BV-2 microglial cells.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Canadian Patent Application CA 2929001 A1 to Yoo et. al. (herein after Yoo’001; cited in the office action dated April 7th, 2025) in view of Park et. al. ((2010), Glabridin inhibits Lipopolysaccharide-induced Activation of a Microglial Cell Line, BV-2, by Blocking NF-kB and AP-1, Phytother. Res., 24, 29 – 34) as applied to claims 5 – 10 above, and further in view of Atrahimovich et. al. ((2012), Glabridin Protects Paraoxonase 1 from Linoleic Acid Hydroperoxide Inhibition via Specific Interaction: A Fluorescence-Quenching Study, J. Agric. Food Chem., 60, 3679 – 3685).
The teachings of Yoo’001 and Park et. al. as they relate to claim 5, from which claim 14 depend, are given previously in this office action and are fully incorporated here.
However, the prior art of Yoo’001 and Park et. al. fail to teach a method wherein preventing inhibition of Paraoxonase 1 (PON1) activity is determined by an assay in which recombinant PON1 activity is inhibited by oxidized linolenic acid and the PON1 activity is measured using 5-thiobutyl butyrolactones (TBBL) as a substrate (claim 14).
Nevertheless, Atrahimovich et. al. teach that Paraoxonase 1 (PON1; EC 3.1.8.1) is a calcium-dependent enzyme that binds to high-density lipoprotein (HDL) (page 3679 column 1 paragraph 1). Atrahimovich et. al. teach flavonoids are important dietary polyphenols found in fruits, vegetables, nuts, and tea, which can prevent diseases such as cancer, cardiovascular disease, and neurodegenerative disorders (page 3679 column 1 paragraph 2). Furthermore, Atrahimovich et. al. teach that there are several methods to characterize flavonoid−protein interactions, such as fluorescence, absorption, circular dichroism, and lifetime measurements with fluorescence assay provides many advantages, such as high sensitivity, high selectivity, easy operation, and low cost, and it has been widely applied to the study of protein−drug interactions (page 3679 column 1 paragraph 2). Moreover, Atrahimovich et. al. teach that rePON1 activity was tested by incubating glabridin (100 μM) was incubated with rePON1 (5 μg/mL for lactonase activity or 10 μg/mL for paraoxonase activity) for 15 min (page 3680 column 1 paragraph 2). Furthermore, Atrahimovich et. al. teach that atherosclerotic LLE (0.7 mg/mL) or oxidized – linoleic acid (OX-LA) (30 μM) was added and the resulting mixture incubated for another 5 or 2 hours, respectively, in Tris−HCl buffer (50 mM, pH 8) containing 1 mM CaCl2 (page 3680 column 1 paragraph 2). Moreover, Atrahimovich et. al. teach that a 145 μL aliquot of DTNB (0.5 mM in Tris− HCl buffer) was placed in a visible (vis) enzyme-linked immunosorbent assay (ELISA) microplate well; then 5 μL of the rePON1 sample described above and 95 μL of TBBL (4 mM in Tris−HCl buffer) were added with the catalytic activity of rePON1 being measured spectrophotometrically at 405 nm for 10 min every 0.5 min (page 3680 column 1 paragraph 3). Furthermore, Atrahimovich et. al. teach that glabridin protected rePON1 from inhibition by LLE in a dose-responsive manner (1−100 μM glabridin prevented the enzyme’s inhibition by up to 22%) (page 3681 column 2 paragraph 1).
Therefore, it would have been obvious before the effective filing date of the instant application to use the chemically stable glabridin derivatives of Yoo’001, that is prior art compounds 4, 5, and 15 in methods of treating inflammatory disorders in view of Park et. al. that is in a method of treating Parkinson’s disease in further view of Atrahimovich et. al., that is to determine PON1 activity by using assay in which recombinant PON1 activity is inhibited by oxidized linolenic acid and the PON1 activity is measured using 5-thiobutyl butyrolactones (TBBL) as a substrate. One of ordinary skill in the art would have been motivated to make this modification to determine the activity of glabridin like compounds against PON1. One of ordinary skill in the art would have had a reasonable expectation of success because glabridin a chemically similar compound to prior art compounds 4, 5, and 15, protected rePON1 from inhibition by LLE in a dose-responsive manner (1−100 μM glabridin prevented the enzyme’s inhibition by up to 22%).
Response to Arguments
Applicant’s claim amendments, arguments, and declaration , see pages 7 – 9, filed November 19th, 2025, with respect to the prior art rejections of claims 5 – 10, and 14 under 35 USC § 103 have been fully considered and have been found persuasive. However, the rejection was amended to address newly amended claim 5 recitation wherein the neurological disease is Parkinson’s disease.
Applicant argues that the declaration submitted March 5th, 2026 demonstrates the markedly improved brain to plasma ration the instant compound Vutiglabridin (see applicants remarks page8 paragraph 3 – 4).
The examiner contends that when establishing an unexpected results there must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness (MPEP 716.02( e)). In the declaration case the applicant has chosen to compare glabridin to the instant compound vutiglabridin (see Declaration pages 2 – 10). While the examiner agrees that the compound vutiglabridin is unexpectedly better then glabridin; however, as evidenced by PubChem (National Center for Biotechnology Information (2026). PubChem Compound Summary for CID 118204185, Vutiglabridin. Retrieved April 2, 2026 from https://pubchem.ncbi.nlm.nih.gov/compound/Vutiglabridin), the chemical structure of vutiglabridin is
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which is identical to prior art compound 15
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taught by Yoo’001 above (page 16 paragraph 00116).
Thus the examiner contends that "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. (MPEP 2112.01 (II)). Moreover, a claimed compound may be obvious because it was suggested by, or structurally similar to, a prior art compound even though a particular benefit of the claimed compound asserted by patentee is not expressly disclosed in the prior art. It is the differences, in fact, in their respective properties which are determinative of nonobviousness. If the prior art compound does in fact possess a particular benefit, even though the benefit is not recognized in the prior art, applicant’s recognition of the benefit is not in itself sufficient to distinguish the claimed compound from the prior art. In re Dillon, 919 F.2d 688, 693, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc).(MPEP 2144.09(VII)).
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 5 – 10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 4, and 16 – 19 of U.S. Patent No. US 9783551 B2 to Yoo et. al. (herein after Yoo’551) in view of Park et. al. ((2010), Glabridin inhibits Lipopolysaccharide-induced Activation of a Microglial Cell Line, BV-2, by Blocking NF-kB and AP-1, Phytother. Res., 24, 29 – 34) and Atrahimovich et. al. ((2012), Glabridin Protects Paraoxonase 1 from Linoleic Acid Hydroperoxide Inhibition via Specific Interaction: A Fluorescence-Quenching Study, J. Agric. Food Chem., 60, 3679 – 3685).
Yoo’551 recite a compound and pharmaceutical composition of the following Formula (I), a pharmaceutically acceptable salt thereof: Formula (I)
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(reference claim 1; instant claims 5 – 10); wherein R1 = H (reference claims 2 and 17); R2 = ethoxy (reference claim 3 and 18). More specifically, Yoo’551 recites the following compounds compound 4
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, compound 5
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, compound 16
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, compound 17
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(reference claim 4 and 19; instant claims 5-10).
However, Yoo’551 fails to recite a method for preventing or treating neurological disease wherein the neurological disorder is Parkinson’s disease (instant claim 5).
Nevertheless, Yoo’551 recited compounds that are identical to those claimed in the instant application, thus where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). (MPEP 2112.01). Additionally, if "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Therefore, since Yoo’551 teach compounds that are identical to the instant application; the prior art pharmaceutical compositions of Yoo’551 can be used for preventing or treating neurological disease.
Nevertheless, the teachings of Park et. al. and Atrahimovich et. al. as they relate to the prior art rejections of claims 5 – 10, and 14 are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to use the compounds of the invention of Yoo’551 in methods of treating inflammatory disorders in view of Park et. al. that is in a method of treating Parkinson’s disease in further view of Atrahimovich et. al., that is to determine PON1 activity by using assay in which recombinant PON1 activity is inhibited by oxidized linolenic acid and the PON1 activity is measured using 5-thiobutyl butyrolactones (TBBL) as a substrate. One of ordinary skill in the art would have been motivated to make this modification to mitigate microglia the innate immune cells resident in the brain. One of ordinary skill in the art would have had a reasonable expectation of success because glabridin a chemically similar compound to prior art compounds 4, 5, and 15, inhibited the production of NO, TNF-α and IL-1β in LPS stimulated BV-2 microglial cells. Moreover, one of ordinary skill in the art would have been motivated to make this modification to determine the activity of glabridin like compounds against PON1. One of ordinary skill in the art would have had a reasonable expectation of success because glabridin a chemically similar compound to prior art compounds 4, 5, and 15, protected rePON1 from inhibition by LLE in a dose-responsive manner (1−100 μM glabridin prevented the enzyme’s inhibition by up to 22%).
Response to Arguments
Applicant’s claim amendments and arguments, see page 10 – 11, filed March 5th , 2026, with respect to the NSDP of instant claims 5 – 10, and 14 over claims 1 – 2 of U.S. Patent No. US 9783551 B2 to Yoo et. al. (herein after Yoo’551) have been fully considered and have been found persuasive. However, the rejection was amended to address newly amended instant claim 5 recitation wherein the neurological disease is Parkinson’s disease.
Applicants argues that the newly amended claims 5 – 10 of the instant application are distinct from claims 1 – 2 of the conflicting Yoo’551 (see applicant’s remarks page 10 paragraph 5). Specifically, applicant argues that neither Yoo’551 nor Cui et. al. direct to a method of treating Parkinson’s Disease (see applicant’s remarks page 10 paragraph 5).
However, the examiner contends that the compounds of the instant claims are still identical to those taught by the invention of Yoo’551 as stated above on the NSDP rejection. Moreover, the rejection was modified to address the limitation for a method for preventing or treating a neurological disorder wherein the neurological disorder is Parkinson’s Disease is rendered obvious in view of Park et. al. Additionally, the arguments of applicant (applicant remarks page 10 – 11) are largely the same as for the prior art obviousness rejection and are not persuasive for the same reasons, as stated above in the response to arguments.
Conclusion
Claims 5 – 10, and 14 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel 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.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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