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 .
Priority
The present application, filed on January 27, 2022, claims the benefit of U.S. Provisional Application Nos. 62/897,844, filed on September 9, 2019, and 63/010,655, filed on April 15, 2020.
The contents of claims 1-16 and 18 are supported by the original disclosure provided in of U.S. Provisional Application Nos. 62/897,844, filed on September 9, 2019, thus the effective filing date for claims 1-16 and 18 is September 9, 2019.
The limitations of claims 17 are not supported by the original disclosure provided in disclosure provided in of U.S. Provisional Application Nos. 62/897,844, filed on September 9, 2019, but are supported by the disclosure provided in U.S. Provisional Application No. 63/010,655, filed on April 15, 2020, thus the effective filing date for claim 18 is April 15, 2020.
Information Disclosure Statement
Three Information Disclosure Statements (IDSs), 08/04/20223, 09/25/2025, and 02/24/2026 are acknowledged and considered.
Claim Status
Claims 1-2 and 7-18 are pending. Claims 3-6 are canceled. Claims 1-2 and 7-18 are examined herein below.
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.
Claim(s) 1, 7-11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al., (PG Pub No. US20080187936 A1, provided in IDS filed 08/04/2023, U.S. Patent Pub Cite No. 2), in view of Guthrie (PG Pub No. US2014/0371303 A1, Pub. Date: 12/18/2014), and Roland et al., (Roland et al., 6-Methoxyflavanones as Bitter Taste Receptor Blockers, for hTAS2R39, 2014, PLOS ONE, 9, 4, 1-10).
Throughout the disclosure, Li teaches specific human taste G-protein coupled receptors (GPCRs) in the T2R taste receptor family respond to particular bitter compounds. Li teaches assays with these taste receptors to identify ligands/compounds that modulate, preferably inhibit, their activation and that can be used as additives in foods, beverages, cosmetics and medicines to block T2R-associated bitter taste, which results by the activation of these taste receptors by bitter compounds (Abstract and paras, 0002, 0041, 0061). Li teaches one objective of the invention is to use inhibitor compounds that block stimulation or activation by bitter compounds and down regulate taste transduction in T2R-associated bitter taste in T2R family receptors (paras 0012, 0041, 0060). Li teaches an assay method comprising expressing T2R family taste receptors in cells or on cell membranes, applying putative modulator (test) compounds in the presence and absence of bitter compounds, and determining the functional effects on taste transduction. Li teaches functional effects of samples comprising taste receptor proteins, a modulator (test) compound, and a bitter compound, which are compared to that of control samples, comprising receptor protein(s) and a bitter compound, without the putative modulator (test) compound (para 0061).
Regarding claim 1, the Specification of this instant application clarifies that “test compound” is defined as an active compound that reduces bitter taste (instant Spec, lines 19-20). Li teaches putative modulator compounds which may activate or inhibit/block T2R-associated bitter taste. Li teaches identifying putative modulator compounds, which Li defines as molecules that modulate, preferably block, the bitter taste associated with bitter compounds. Thus, using the broadest reasonable interpretation in light of the instant Specification, putative modulator compound, taught by Li, is interpreted to mean test compound, as recited and defined in the instant disclosure. Thus, Li reads on the limitations of claim 1 reciting a method of identifying compounds that reduce bitter taste, the method comprising (US20080187936 A1: Abstract and paras 0002, 0012, 0041, 0061): introducing a test compound and a bitter compound to one or more taste receptor proteins (US20080187936 A1: para 0061), wherein the one or more taste receptor proteins are polypeptides that comprise: a polypeptide sequence of SEQ ID NO: 1, or a functional fragment thereof; a polypeptide sequence of SEQ ID NO: 2, or a functional fragment thereof; a polypeptide sequence of SEQ ID NO: 3, or a functional fragment thereof; a polypeptide sequence of SEQ ID NO: 4, or a functional fragment thereof; a polypeptide sequence of SEQ ID NO: 5, or a functional fragment thereof; or a polypeptide sequence whose sequence is at least 90% equivalent to any of the foregoing (US20080187936 A1: paras 0038 and 0047); and measuring a response of each of the one or more taste receptor proteins to the test compound by comparing an activity of the one or more taste receptor proteins to the bitter compound in the presence and the absence of the test compound (US20080187936 A1: para 0061).
Li further teaches the recited test receptors with the following sequences:
SEQ ID NO: 1 (equivalent to Li’s SEQ ID NO: 12)
SEQ ID NO: 2 (equivalent to Li’s SEQ ID NO: 24)
SEQ ID NO: 3 (equivalent to Li’s SEQ ID NO: 28)
SEQ ID NO: 4 (equivalent to Li’s SEQ ID NO: 38)
SEQ ID NO: 5 (equivalent to Li’s SEQ ID NO: 44)
Li does not teach wherein the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid; and wherein the test compound is a polymethoxyflavone (PMF).
Throughout the disclosure, Guthrie teaches compositions and methods for glycemic control in Subjects with impaired fasting glucose and for improving glycemic control in Subjects using conventional therapies (US 2014/0371.303 A1: Abstract and para 0001). Guthrie teaches methods that may include administering an effective dose of a composition to a subject diagnosed with diabetes and using conventional therapies (US 2014/0371.303 A1: para 0012). Guthrie further teaches such compositions may include at least one of limocitrin derivative, quercetin derivative, polymethoxyflavone, tocotrienol and mixtures, at least one limonoid, at least one flavonoid, at least one polymethoxyflavone thereof alone or in combination with at least one glycemic control drug for the treatment, such as metformin, of subjects with impaired fasting glucose (US 2014/0371.303 A1: paras 0012 and 0017).
Guthrie teaches the limitation(s) of claim 1 reciting wherein the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid; [US2014/0371303: paras 0012, 0017, and 0037]. Li and Guthrie do not teach wherein the test compound is a polymethoxyflavone (PMF).
Throughout the disclosure, Roland teaches fourteen flavanones, some classified as PMFs, were investigated as test compounds with the potential to reduce activation of a taste receptor protein by epicatechin gallate (ECG), one of the main bitter compounds found in green tea. Three flavanones, specifically (in order of decreasing potency) 49-fluoro-6-methoxyflavanone (a PMF), 6,39-dimethoxyflavanone (a PMF), and 6-methoxyflavanone showed inhibitory behavior towards the activation of a taste receptor protein by ECG. The 6-methoxyflavanones also inhibited activation of another bitter receptor activated by ECG, though not to the same extent. Roland further teaches dose-response curves of ECG at various concentrations of the 49-fluoro-6-methoxyflavanone and wash-out experiments indicated reversible insurmountable antagonism.
Roland teaches the limitation(s) of claim 1 reciting wherein the test compound is a polymethoxyflavone (PMF) [Roland et al., 2014, PLOS ONE, 9, 4, pg. 1, Abstract; pgs. 1-2, Introduction; pg. 3, Table 1].
It would have been prima facie obvious, at the time of filing, to try and select the polypeptides that comprise SEQ ID NOs: 1-5, included in the finite list of polypeptides taught by Li, to find the optimal list of polypeptides and arrive at the claimed invention because Li teaches a finite number of taste receptor polypeptides capable of activation by bitter compounds. A skilled artisan would have a reasonable expectation of success because Li teaches a finite number of known solutions, that is a finite number of taste receptor polypeptides activated by bitter compounds found in foods, beverages, and pharmaceutical compositions.
It would have been further prima facie obvious, at the time of filing, to combine the method of identifying compounds that reduce bitter taste, as taught by Li, with the teachings for the plant families of the bitter compound extract and the class of the bitter compound shown to have health benefits, as taught by Guthrie, with the teachings of PMFs as test compounds shown to reduce bitter taste, as taught by Roland. A skilled artisan would have been motivated to combine the teachings of Li, Guthrie, and Roland because it would enable a skilled artisan to determine PMF compounds capable of blocking bitter taste, instead of masking bitter taste, that could be used as additives to reduce bitter taste in foods, beverages, and medicines without removing the health benefits of natural bitter compounds. A person having ordinary skill in the art would have a reasonable expectation of success because combining the teachings of Li, Guthrie, and Roland amounts to combining known elements, with each method or element having the same function separately as they do when combined, to yield expected and predictable results.
Regarding claims 7-11 and 16, Li, Guthrie, and Roland teach all the limitation of claim 1. Guthrie further teaches bitter compounds are extracts of a plant from the Meliaceae family or a plant from the Rutaceae family [claim 7] (US2014/0371303: para 0037); wherein the bitter compound is an extract of a plant from the Rutaceae family and the Citrus genus [claim 8] (US2014/0371303: paras 0035-0038); wherein the bitter compound is a triterpene [claim 9] (US2014/0371303: paras 0037 and 0039); wherein the bitter compound is a tetranortriterpenoid [claim 10] (US2014/0371303: paras 0037 and 0039); wherein the bitter compound is a limonoid [claim 11] (US2014/0371303: paras 0037 and 0039); and the extract is an extract from the tree or fruit of orange, lemon, grapefruit, lime, kumquat, pomelo, tangelo, ugli, tangerine, or yuzu [claim 16] (US2014/0371303: paras 0018, 0021, and 0035-0037).
It would have been prima facie obvious, at the time of filing, to combine the method of identifying compounds that reduce bitter taste as disclosed in claim 1 and as taught by Li, in view of Roland, with the teachings of the plant family, broader class, subclass, and specific type of extract for bitter compounds that have important health benefits, as taught by Guthrie. A skilled artisan would have been motivated to combine these teachings because it would enable a skilled artisan to find a test compound that would reduce the bitterness of bitter compounds found to have important health benefits and that are naturally found in foods and incorporated into medicines so that these daily consumable products can have an acceptable taste without removing their beneficial effects. A person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings amounts to combining known elements that perform the same function separately as they do when combined, according to known methods, to yield expected and predictable results.
Regarding claims 14-15, Li, Guthrie, and Roland teach all the limitation of claim 1. Li further teaches wherein the one or more taste receptor proteins are each expressed on a surface of a cell (US20080187936 A1: para 0061) and wherein the cell is a eukaryotic cell (US20080187936 A1: paras 0011, 0039, and 0126).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al., (PG Pub No. US20080187936 A1, provided in IDS filed 08/04/2023, U.S. Patent Pub Cite No. 2), and as evidenced by Karanewsky et al., (U.S. Patent No. 8,445,692 B2, Patent Date: 05/21/2013).
Regarding claim 2, in separate embodiments, Li teaches the method of wherein the introducing step comprises introducing a test compound and a bitter compound to two or more taste receptor proteins, wherein the two or more taste receptor proteins are independently selected from polypeptides that comprise: a polypeptide sequence of SEQ ID NO: 2, or a functional fragment thereof; a polypeptide sequence of SEQ ID NO: 4, or a functional fragment thereof; a polypeptide sequence of SEQ ID NO: 5, or a functional fragment thereof; or a polypeptide sequence whose sequence is at least 90% equivalent to any of the foregoing; and wherein the measuring step comprises measuring a response of each of the two or more taste receptor proteins to the test compound by comparing an activity of the two or more taste receptor proteins to the bitter compound in the presence and the absence of the test compound (US20080187936 A1: paras 0061 and 0189).
Li further teaches the recited test receptors of claim 1 having the following sequence identities:
SEQ ID NO: 2 (equivalent to Li’s SEQ ID NO: 24) at 100% identity;
SEQ ID NO: 4 (equivalent to Li’s SEQ ID NO: 38) at 99.9% identity; and
SEQ ID NO: 5 (equivalent to Li’s SEQ ID NO: 44) at 100% identity
It would have been prima facie obvious, at the time of filing, to combine the different embodiments for the method of identifying compounds that reduce bitters taste to two or more taste receptor proteins taught by Li in the same reference. A skilled artisan would have been motivated to combine the different embodiments of Li because it would enable finding a test compound that binds a plurality of taste receptor proteins, rather than one taste receptor protein, leading to broader suppression of bitter taste that can be used in diverse consumables including foods, beverages, and medicines (see Karanewsky et al., U.S. Patent No. 8,445,692 B2, col. 5, lines 39-49). A skilled artisan would have a reasonable expectation of success combining different embodiments taught in the same reference because this amounts to combining known elements, with each method and/or element known to have the same function separately as they do when combine, to yield expected and predictable results.
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al., (PG Pub No. US20080187936 A1, provided in IDS filed 08/04/2023, U.S. Patent Pub Cite No. 2), in view of Guthrie et al., (PG Pub No. US2014/0371303, Pub. Date: 12/18/2014), and Roland et al., (Roland et al., 6-Methoxyflavanones as Bitter Taste Receptor Blockers, for hTAS2R39, 2014, PLOS ONE, 9, 4, 1-10), as applied to claims 1 and 11 above, and further in view of Konno et al., (Konno et al., Bitterness Reduction of Naringin and Limonin by β-Cyclodextrin, 1982, Agric. Bioi. Chern., 46, 9, 2203-2208).
Regarding claims 12-13, the teaching of Li, Guthrie, and Roland are discussed herein above. Li, Guthrie, and Roland teach all the limitation of claims 1 and 11. Li, Guthrie, and Roland do not teach wherein the bitter compound is limonin, nomilin, nomilic acid, azadirachtin, or any combination thereof.
Throughout the article Konno teaches the bitterness of bitter compounds limonin in citrus juice is reduced by approximately half in the presence of a specific inhibitor compound, β-cyclodexin. Konno teaches reduction in bitter taste of limonin is a result from the formation of a -cyclodexin: limonin complex.
Konno teaches wherein the bitter compound is limonin, nomilin, nomilic acid, azadirachtin, or any combination thereof and wherein the bitter compound is limonin (Konno et al., 1982, Agric. Bioi. Chern., 46, 9, pg.2203, Abstract and full para 1).
It would have been prima facie obvious, at the time of filing, to combine the method disclosed in claims 1 and 11 of identifying compounds that reduce bitter taste by blocking taste receptor activation by a bitter compound, as taught by Li, in view of Guthrie and Roland, with the teachings that a bitter compound is limonin, as taught by Konno. As discussed above, Konno teaches limonin, a specific type of limonoid, is a natural bitter tasting component of citrus fruits and their products, which make these products unacceptable for consumption when its bitter taste is too intense. Further, Guthrie teaches that limonoids have health benefits and may be formulated into pharmaceuticals to administer to patients to treat insulin resistance or cardiovascular conditions, among other diseases (US 2014/0371.303 A1: paras 0012 and 0043). Thus, a skilled artisan would have been motivated to combine these teachings to arrive at the claimed invention because it would reduce the bitter taste of limonin, a major component of common and commercially available citrus fruits and their products, without removing their beneficial effects. A person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings amounts to combining known elements that perform the same separately as they do when combine, according to known methods, to yield expected and predictable results.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al., (PG Pub No. US20080187936 A1, provided in IDS filed 08/04/2023, U.S. Patent Pub Cite No. 2), in view of Guthrie et al., (PG Pub No. US2014/0371303, Pub. Date: 12/18/2014), and Roland et al., (Roland et al., 6-Methoxyflavanones as Bitter Taste Receptor Blockers, for hTAS2R39, 2014, PLOS ONE, 9, 4, 1-10).
Regarding claims 17, Li, Guthrie, and Roland teach all the limitation of claim 1. Guthrie further teaches polymethoxyflavone is a compound selected from the group consisting of: 5,6,7,3',4'-Pentamethoxyflavone; 3,5,6,7,3',4'- Hexamethoxyflavone; 5,6,7,8,3',4'-Hexamethoxyflavone; 5,6,7,4'-Tetramethoxyflavone; 3,5,6,7,8,3',4'-Heptamethoxyflavone; 5,6,7,8,4'-Pentamethoxyflavone; 5-Hydroxy-6,7,3',4'- tetramethoxyflavone; 5-Hydroxy-3,6,7,3',4'-pentamethoxyflavone; 5-Hydroxy-6,7,8,3',4'- pentamethoxyflavone; 5-Hydroxy-6,7,4'-trimethoxyflavone; 5-Hydroxy-3,6,7,8,3',4'- hexamethoxyflavone; 5-Hydroxy-6,7,8,4'-tetramethoxyflavone; 4'-Hydroxy-5,6,7,3'- tetramethoxyflavone, and 4'-Hydroxy-3,5,6,7,8,3'-hexamethoxyflavone (US 2014/0371303 A1: paras 0019-0020, 0024).
It would have been prima facie obvious, at the time of filing, to combine the method of identifying test compounds, wherein a test compound is a PMF, that reduce bitter taste, as taught by Li, in view of Guthrie and Roland, with the teachings of a finite group of specific PMFs as further taught by Guthrie. Guthrie teaches PMFs as bitter compounds that have health benefits (see US 2014/0371303 A1: paras 0011-0012, 0033, 0035) and Roland teaches that some PMFs can also function as bitter taste reducers by inhibiting activation of a taste receptor protein by other bitter compounds. Thus, a skilled artisan would have been motivated to combine these teachings because it would enable blocking the activation of bitter taste using PMF test compounds that have health benefits while also not removing the health benefits of the bitter compound. A person having ordinary skill in the art would have been further motivated to combine these teachings and perform routine optimization and try the finite number of identified PMFs taught by Guthrie to determine which PMF would be the optimal test compound to arrive at the claimed invention. A person having ordinary skill in the art would have a reasonable expectation of success because combining these known teachings amounts to (1) combining known elements, known to perform the same function separately as they do when combined, according to known methods/techniques to yield expected and predictable results and (2) combining these teachings and performing routine optimization by trying a finite number of known (identified) PMFs, which are predictable solutions, would also yield expected and predictable results.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al., (PG Pub No. US20080187936 A1, provided in IDS filed 08/04/2023, U.S. Patent Pub Cite No. 2), in view of Guthrie et al., (PG Pub No. US2014/0371303, Pub. Date: 12/18/2014), and Roland et al., (Roland et al., 6-Methoxyflavanones as Bitter Taste Receptor Blockers, for hTAS2R39, 2014, PLOS ONE, 9, 4, 1-10), as evidenced by Karanewsky et al., (U.S. Patent No. 8,445,692 B2, Date of Patent: 05/21/2013).
Regarding claim 18, the teachings of Li, Guthrie, and Roland are discussed herein above. Li teaches a method of identifying compounds that reduce bitter taste, the method comprising: introducing a test compound and a bitter compound to a plurality of taste receptor proteins, wherein the plurality of taste receptor proteins comprise: a first polypeptide comprising a sequence of SEQ ID NO: 1, or a functional fragment thereof; a second polypeptide comprising a sequence of SEQ ID NO: 2, or a functional fragment thereof; a third polypeptide comprising a sequence of SEQ ID NO: 3, or a functional fragment thereof; a fourth polypeptide comprising a sequence of SEQ ID NO: 4, or a functional fragment thereof; and a fifth polypeptide comprising sequence of SEQ ID NO: 5, or a functional fragment thereof. Li teaches the recited test receptors of claim 18 with the following sequence identities:
SEQ ID NO: 1 (equivalent to Li’s SEQ ID NO: 12) at 100% identity;
SEQ ID NO: 2 (equivalent to Li’s SEQ ID NO: 24) at 100% identity;
SEQ ID NO: 3 (equivalent to Li’s SEQ ID NO: 28) at 100% identity;
SEQ ID NO: 4 (equivalent to Li’s SEQ ID NO: 38) at 99.9% identity; and
SEQ ID NO: 5 (equivalent to Li’s SEQ ID NO: 44) at 100% identity
Li further teaches measuring a response of each of the plurality of taste receptor proteins to the test compound by comparing an activity of the plurality of taste receptor proteins to the bitter compound in the presence and the absence of the test compound; and determining that the test compound is an active bitter taste reducer. [US20080187936 A1: paras 0038; 0041; 0047; 0061; 0173; 0189] Li does not teach wherein the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid.
However, Guthrie teaches wherein the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid (US2014/0371303: paras 0012, 0017, and 0037). Li and Guthrie do not teach wherein the test compound is a polymethoxyflavone (PMF).
However, Roland teaches wherein the test compound is a polymethoxyflavone (PMF) [Roland et al., 2014, PLOS ONE, 9, 4, pg. 1, Abstract; pg. 3, Table 1 and Fig. 2; pg. 4, Results; and pg. 7, Discussion]. Roland further teaches teach the test compound is an active bitter taste reducer based on antagonization of at least 30% of binding activity of the bitter taste compound to each of the first, second, third, fourth, and fifth polypeptides (Roland et al., 2014, PLOS ONE, 9, 4, pg. 1, Abstract; pg. 3, full paras 1-2, Table 1, and Fig. 2; pg. 4-6, Results; pg. 5, Table 2 and pg. 7, Discussion).
It would have been prima facie obvious, at the time of filing, to combine the different embodiments for the method of identifying compounds that reduce bitters taste to a plurality of taste receptor proteins taught by Li in the same reference. A skilled artisan would have been motivated to combine the different embodiments of Li because it would enable finding a test compound that binds a plurality of taste receptor proteins, rather than one taste receptor protein, leading to broad, and more effective, suppression of bitter taste that can be used in a diverse range of consumables, for humans or animals, including foods, beverages, and medicines (see Karanewsky et al., U.S. Patent No. 8,445,692 B2, col. 5, lines 39-49). A skilled artisan would have a reasonable expectation of success because combining embodiments taught in the same reference amounts to combining known elements, with each method and/or element having the same function separately as they do when combined, to yield expected and predictable results.
It would have been further prima facie obvious, at the time of filing, to combine the teachings of identifying compounds that reduce bitter taste for a plurality of taste receptor proteins, as taught by Li, with the teachings for the plant families for the source of the bitter taste extract and for the class of the bitter compound which has health benefits, as taught by Guthrie, with the teachings of PMFs shown to reduce bitter taste by inhibiting activation of a taste receptor protein, as taught by Roland. A skilled artisan would have been motivated to combine the teachings of Li, Guthrie, and Roland because it would enable a skilled artisan to determine a PMF, which are known to have health benefits (see US 2014/0371303 A1: paras 0011-0012, 0033, 0035), capable of reducing bitter taste of a bitter compound also shown to have health benefits and naturally found in citrus fruits and their products and incorporated into medicines, to be used as an additive to improve the taste of foods, beverages, and medicines without removing beneficial effects of the bitter compound and the PMF bitter taste reducer (test compound). A person having ordinary skill in the art would have a reasonable expectation of success because combining the teachings of Li, Guthrie, and Roland amounts to combining known elements, with each method or element known to have the same function separately as they do when combined, to yield expected and predictable results.
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 1-2 and 7-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 7, 9-10, 12, 14 and 17 of later filed co-pending U.S. Patent Application No. 19/717,767 in view of Guthrie et al., (PG Pub No. US2014/0371303, Pub. Date: 12/18/2014), and Roland et al., (Roland et al., 6-Methoxyflavanones as Bitter Taste Receptor Blockers, for hTAS2R39, 2014, PLOS ONE, 9, 4, 1-10). This is a provisional nonstatutory double patenting rejection.
The teachings of Guthrie and Roland are discussed herein above.
Regarding instant claims 1-2 and 7-17, all limitations are recited by the reference claims 1, 3-4, 7, 9-10, 12, 14 and 17, except the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid; and wherein the test compound is a polymethoxyflavone (PMF).
However, Guthrie, in the same field of endeavor, recites wherein the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid; [US2014/0371303: paras 0012, 0017, and 0037]. The reference application ‘767 and Guthrie do not teach wherein the test compound is a polymethoxyflavone (PMF).
However, Roland teaches wherein the test compound is a polymethoxyflavone (PMF) [Roland et al., 2014, PLOS ONE, 9, 4, pg. 1, Abstract; pgs. 1-2, Introduction; pg. 3, Table 1].
Application ‘767 reference claims 1, 3-4, 7, 9-10, 12, 14 and 17 are an obvious variation of instant claims 1-2 and 7-17 because it would have been prima facie obvious, at the time of filing, to combine the broader limitations for the bitter compound recited in reference application ‘767 with the teachings of the plant family for the bitter compound extract shown to have health benefits, as taught by Guthrie, with the teachings of PMFs as test compounds shown to reduce bitter taste, as taught by Roland. A skilled artisan would have been motivated to combine the known and broader limitation(s) for bitter compound as recited by Reference application ‘767, with Guthrie, and Roland because it would enable a skilled artisan to determine PMF test compounds shown to have health benefits and capable of blocking bitter taste, instead of masking bitter taste, that could be used as additives to reduce bitter taste in foods, beverages, and medicines without removing the health benefits of natural bitter compounds. A person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings amounts to combining known elements, with each method or element having the same function separately as they do when combined, to yield expected and predictable results.
Claims 1 and 7-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-8, and 15-16 of later filed co-pending U.S. Patent Application No. 18/858,159 in view of Guthrie et al., (PG Pub No. US2014/0371303, Pub. Date: 12/18/2014), and Roland et al., (Roland et al., 6-Methoxyflavanones as Bitter Taste Receptor Blockers, for hTAS2R39, 2014, PLOS ONE, 9, 4, 1-10). This is a provisional nonstatutory double patenting rejection.
The teachings of Guthrie and Roland are discussed herein above.
Regarding instant claims 1 and 7-17, all limitations are recited by the reference claims 1-2, 7-8, and 15-16, except the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid; and wherein the test compound is a polymethoxyflavone (PMF).
However, Guthrie, in the same field of endeavor, recites wherein the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid; [US2014/0371303: paras 0012, 0017, and 0037]. The reference application ‘159 and Guthrie do not teach wherein the test compound is a polymethoxyflavone (PMF).
However, Roland teaches wherein the test compound is a polymethoxyflavone (PMF) [Roland et al., 2014, PLOS ONE, 9, 4, pg. 1, Abstract; pgs. 1-2, Introduction; pg. 3, Table 1].
Application ‘159 reference claims 1-2, 7-8, and 15-16 are an obvious variation of instant claim 2 because it would have been prima facie obvious, at the time of filing, to combine the broader limitations for the bitter compound recited in reference application ‘159 with the teachings of the plant family for the bitter compound extract compound shown to have health benefits, as taught by Guthrie, with the teachings of PMFs as test compounds shown to reduce bitter taste, as taught by Roland. A skilled artisan would have been motivated to combine the known and broader limitation(s) for bitter compound as recited by Reference application ‘159, with Guthrie, and Roland because it would enable a skilled artisan to determine PMF test compounds shown to have health benefits and capable of blocking bitter taste, instead of masking bitter taste, that could be used as additives to reduce bitter taste in foods, beverages, and medicines without removing the health benefits of natural bitter compounds. A person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings amounts to combining known elements, with each method or element having the same function separately as they do when combined, to yield expected and predictable results.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-8, and 15-16 of later filed co-pending U.S. Patent Application No. 18/858,159 in view of Li et al., (US20080187936 A1, provided in IDS filed 08/04/2023. This is a provisional nonstatutory double patenting rejection.
Regarding instant claims 2, all limitations are recited by the reference claims 1-2, 7-8, and 15-16, except “two or more taste receptor proteins.”
However, Li, in separate embodiments, teaches the method recited in instant claim 1 and further comprising two or more taste receptor proteins are independently selected from polypeptide sequence of the recited SEQ ID NOs.
Application ‘159 reference claims 1-2, 7-8, and 15-16 are an obvious variation of instant claim 2 because it would have been prima facie obvious, at the time of filing, to combine application ‘159 reference claims 1-2, 7-8, and 15-16 with the embodiments of the method of identifying compounds that reduce bitter taste, as taught by Li. A skilled artisan would have been motivated to combine the limitations recited in reference application ‘159 claims 1-2, 7-8, and 15-16 with the different embodiments of Li because it would enable finding a test compound that binds a plurality of taste receptor proteins, rather than one taste receptor protein, leading to broader suppression of bitter taste that can be used in diverse consumables including foods, beverages, and pharmaceutical compositions. A skilled artisan would have a reasonable expectation of success making this combination because it amounts to combining known elements, with each method and/or element known to have the same function separately as they do when combined, to yield expected and predictable results.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-8, and 15-16 of later filed co-pending U.S. Patent Application No. 18/858,159 in view of Guthrie et al., (PG Pub No. US2014/0371303, Pub. Date: 12/18/2014), Roland et al., (Roland et al., 6-Methoxyflavanones as Bitter Taste Receptor Blockers, for hTAS2R39, 2014, PLOS ONE, 9, 4, 1-10), and Li et al., (US20080187936 A1, provided in IDS filed 08/04/2023.. This is a provisional nonstatutory double patenting rejection.
Regarding instant claim 18, all limitations are recited by the reference claims 1-2, 7-8, and 15-16, except (1) the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid; and wherein the test compound is a polymethoxyflavone (PMF) and (2) a plurality of taste receptor proteins.
The teachings of Li, Guthrie, and Roland are discussed herein above.
Guthrie, in the same field of endeavor, recites wherein the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid; [US2014/0371303: paras 0012, 0017, and 0037]. The reference application ‘159 and Guthrie do not teach wherein the test compound is a polymethoxyflavone (PMF).
However, Roland teaches wherein the test compound is a polymethoxyflavone (PMF) [Roland et al., 2014, PLOS ONE, 9, 4, pg. 1, Abstract; pgs. 1-2, Introduction; pg. 3, Table 1]. The reference application, ‘159, Guthrie, Roland do not teach a plurality of taste test receptors.
Li, in separate embodiments, teaches the method recited in instant claim 1 and further comprising two or more taste receptor proteins are independently selected from polypeptide sequence of the recited SEQ ID NOs.
Application ‘159 reference claims 1-2, 7-8, and 15-16 are an obvious variation of instant claim 18 because it would have been prima facie obvious, at the time of filing, to combine the broader limitations for the bitter compound recited in reference application ‘159 with the teachings of the plant family for the bitter compound extract shown to have health benefits, as taught by Guthrie, with the teachings of PMFs as test compounds shown to reduce bitter taste, as taught by Roland. A skilled artisan would have been motivated to combine the known and broader limitation(s) for bitter compound as recited by Reference application ‘159, with Guthrie, and Roland because it would enable a skilled artisan to determine PMF test compounds, shown to have health benefits, capable of blocking bitter taste, instead of masking bitter taste, that could be used as additives to reduce bitter taste in foods, beverages, and medicines without removing the health benefits of natural bitter compounds. A person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings amounts to combining known elements, with each method or element having the same function separately as they do when combined, to yield expected and predictable results.
Application ‘159 reference claims 1-2, 7-8, and 15-16 are an obvious variation of instant claim 18 because it would have been prima facie obvious, at the time of filing, to combine the teachings of reference application ‘159 claims 1-2, 7-8, and 15-16 with the different embodiments for the method of identifying compounds that reduce bitter taste, as taught by Li. A skilled artisan would have been motivated to combine the limitations recited in reference application ‘159 claims 1-2, 7-8, and 15-16 with the different embodiments of Li because it would enable finding a test compound that binds a plurality of taste receptor proteins, rather than one taste receptor protein, leading to broader suppression of bitter taste that can be used in diverse consumables including foods, beverages, and pharmaceutical compositions. A skilled artisan would have a reasonable expectation of success making this combination because it amounts to combining known elements, with each method and/or element known to have the same function separately as they do when combined, to yield expected and predictable results.
Claims 1-2 and 7-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8-12, 19-20 of later filed co-pending U.S. Patent Application No. 18/558,528 in view of Guthrie et al., (PG Pub No. US2014/0371303, Pub. Date: 12/18/2014), and Roland et al., (Roland et al., 6-Methoxyflavanones as Bitter Taste Receptor Blockers, for hTAS2R39, 2014, PLOS ONE, 9, 4, 1-10). This is a provisional nonstatutory double patenting rejection.
Regarding instant claims 1-2, all limitations are recited by the reference claims 1-2, 8-12, and 19-20, except the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid; and wherein the test compound is a polymethoxyflavone (PMF).
However, Guthrie, in the same field of endeavor, recites wherein the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid; [US2014/0371303: paras 0012, 0017, and 0037]. The reference application ‘528 and Guthrie do not teach wherein the test compound is a polymethoxyflavone (PMF).
However, Roland teaches wherein the test compound is a polymethoxyflavone (PMF) [Roland et al., 2014, PLOS ONE, 9, 4, pg. 1, Abstract; pgs. 1-2, Introduction; pg. 3, Table 1].
Application ‘528 reference claims 1-2, 8-12, and 19-20 are an obvious variation of instant claim 2 because it would have been prima facie obvious, at the time of filing, to combine the broader limitations for the bitter compound recited in reference application ‘528 with the teachings of the plant family for the bitter compound extract shown to have health benefits, as taught by Guthrie, with the teachings of PMFs as test compounds shown to reduce bitter taste, as taught by Roland. A skilled artisan would have been motivated to combine the known and broader limitation(s) for bitter compound as recited by Reference application ‘528, with Guthrie, and Roland because it would enable a skilled artisan to determine PMF test compounds shown to have health benefits and capable of blocking bitter taste, instead of masking bitter taste, that could be used as additives to reduce bitter taste in foods, beverages, and medicines without removing the health benefits of natural bitter compounds. A person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings amounts to combining known elements, with each method or element having the same function separately as they do when combined, to yield expected and predictable results.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8-12, 19-20 of later filed co-pending U.S. Patent Application No. 18/558,528 in view of Guthrie et al., (PG Pub No. US2014/0371303, Pub. Date: 12/18/2014), Roland et al., (Roland et al., 6-Methoxyflavanones as Bitter Taste Receptor Blockers, for hTAS2R39, 2014, PLOS ONE, 9, 4, 1-10), and Li et al., (US20080187936 A1, provided in IDS filed 08/04/2023.. This is a provisional nonstatutory double patenting rejection.
Regarding instant claim 18, all limitations are recited by the reference claims 1-2, 8-12, 19-20, except (1) the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid; and wherein the test compound is a polymethoxyflavone (PMF) and (2) a plurality of taste receptor proteins.
The teachings of Li, Guthrie, and Roland are discussed herein above.
Guthrie, in the same field of endeavor, recites wherein the bitter compound is an extract of a plant from the Meliaceae family, an extract of a plant from the Rutaceae family, a terpenoid, or a limonoid; [US2014/0371303: paras 0012, 0017, and 0037]. The reference application ‘528 and Guthrie do not teach wherein the test compound is a polymethoxyflavone (PMF).
However, Roland teaches wherein the test compound is a polymethoxyflavone (PMF) [Roland et al., 2014, PLOS ONE, 9, 4, pg. 1, Abstract; pgs. 1-2, Introduction; pg. 3, Table 1]. The reference application, ‘528, Guthrie, Roland do not teach a plurality of taste test receptors.
Li, in separate embodiments, teaches the method recited in instant claim 1 and further comprising two or more taste receptor proteins are independently selected from polypeptide sequence of the recited SEQ ID NOs.
Application ‘528 reference claims 1-2, 8-12, 19-20 are an obvious variation of instant claim 18 because it would have been prima facie obvious, at the time of filing, to combine the broader limitations for the bitter compound recited in reference application ‘528 with the teachings of the plant family for the bitter compound extract shown to have health benefits, as taught by Guthrie, with the teachings of PMFs as test compounds shown to reduce bitter taste, as taught by Roland. A skilled artisan would have been motivated to combine the known and broader limitation(s) for bitter compound as recited by Reference application ‘528, with Guthrie, and Roland because it would enable a skilled artisan to determine PMF test compounds shown to have health benefits and capable of blocking bitter taste, instead of masking bitter taste, that could be used as additives to reduce bitter taste in foods, beverages, and medicines without removing the health benefits of natural bitter compounds. A person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings amounts to combining known elements, with each method or element having the same function separately as they do when combined, to yield expected and predictable results.
Application ‘528 reference claims 1-2, 8-12, 19-20 are an obvious variation of instant claim 18 because it would have been prima facie obvious, at the time of filing, to combine the teachings of reference application ‘528 claims 1-2, 8-12, 19-20 with the different embodiments for a method of identifying compounds that reduce bitter taste, as taught by Li in the same reference. A skilled artisan would have been motivated to combine the limitations recited in reference application ‘528 claims 1-2, 8-12, 19-20 with the different embodiments of Li because it would enable finding a test compound that binds a plurality of taste receptor proteins, rather than one taste receptor protein, leading to broader suppression of bitter taste that can be used in diverse consumables including foods, beverages, and pharmaceutical compositions. A skilled artisan would have a reasonable expectation of success making this combination because it amounts to combining known elements, with each method and/or element known to have the same function separately as they do when combined, to yield expected and predictable results.
Response to Arguments
Applicant’s arguments with respect to rejections under 35 U.S.C. 103 of claim(s) 1-2 and 7-17 have been considered but are moot because the new ground of rejections rely on a new combination of references and do not rely on the combination of references applied in the prior rejection of record the teaching or matter specifically challenged in the argument.
Applicant’s request that the provisional Double Patenting rejections for instant claims 1-2 and 7-17 be withdrawn upon resolution of rejections under 35 U.S.C. 103 is acknowledged. However, rejections under 35 U.S.C. 103 remain, thus the provisional Double Patenting rejections are maintained.
Regarding Double Patenting, Applicant further remarks that “instant application has an earliest patent term filing date of September 4, 2020, which is earlier than the earliest patent term filing date of any of the cited applications,” are acknowledged. For purposes of clarifying the record, Examiner is aware of the decision in Ex parte Baurin, Appeal 2024-002920, (Application No. 17/135,529) (decided Nov. 11, 2024) (reh’g denied Dec. 18, 2025), where the PTAB reversed five Obviousness-Type Double Patenting (OTDP) rejections that cited later-filed, later-expiring patents as OTDP references and reversed a provisional OTDP rejection over a later-filed pending application with a later patent term filing date, finding that the later-expiring patents/application were not proper OTDP references. However, the Office is actively re-evaluating the PTAB’s stance on whether later-filed or later-expiring patents can be used to support an OTDP rejection, and, as of the date of this Office action, a final decision is pending. Thus, pending further guidance from the Office, the Double Patenting rejections of instant claims in this application that reference later-filed co-pending patent applications is maintained.
Conclusion
All examined claims (1-2 and 7-18) are rejected. No claims are allowed.
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/MELISSA LIZETTE LIRIANO-NG/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 May 26, 2026
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