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 .
Response to Amendment
Applicant's amendment and argument filed 08/20/2025 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 66, 68-73 and 74-82 are pending of which claims 73 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/13/2024.
Claims 66, 68-72 and 74-82 are being examined on the merits.
Claim Objections
Claim 66 is objected to because of the following informalities: The claim recites “Camellia sinensis” twice which is redundant. Appropriate correction is required.
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 66 and 68-72 and 79 are rejected under 35 U.S.C. 103 as being unpatentable over Coulter (WO2008122967A2), and Helieh Oz, (Chronic Inflammatory Diseases and Green Tea Polyphenols, Nutrients, 9(6) 561, 01-Jun-2017). This rejection is newly formed based on the amendments filed on 08/20/2025.
Coulter’s general disclosure is an oral composition comprising mini-capsules wherein the mini-capsules comprise one or more therapeutic or prophylactic substances in a liquid, semi-liquid, or solid core. The mini-capsules have release profiles to release the substance in an active form at one or more sites along the gastro-intestinal tract to maximize absorption and/or therapeutic efficiency (see abstract).
Regarding claims 66 and 69-72 and 79, Coulter teaches an oral formulation (see abstract) comprising antioxidant or nuclear kappa B inhibitors such as curcumin which can reduce nephrotoxicity or increase effectiveness in treating inflammatory bowel disease or to enhance efficacy in the treatment of diabetes-related kidney disorders (see page 65, lines 1-5), and teaches wherein the composition can further comprise SNAC or derivatives thereof (which is/are the instantly claimed compound(s)) to maximize permeability of the active substances (see claim 44). It is known to those skilled in the art that curcumin is an extracted component of Curcuma longa.
Coulter does not specifically teach wherein the formulation also comprises vegetable matter derived from one of the species of newly amended claim 66 part (iii).
Oz’s general disclosure is to green tea polyphenols (see abstract).
Oz teaches “The most prevalent individual polyphenolic constituent, EGCG (98% purity), is believed to account for several therapeutic effects of polyphenols. For instance, GrTPs are reported to attenuate inflammation in different inflammatory bowel disease models [ 9,13,17,30,31]. Following ingestion, GrTPs are extensively dispersed amongst the organs, including the hepatic system [ 32]. However, the antiinflammatory effects of GrTPs are not limited to the scavenging of toxic oxidants, as GrTPs, specifically EGCG, can block the activation of the NF-κB and the release of proinflammatory TNFα in intestinal epithelia [ 14]. The ability of GrTPs to inhibit NF-κB activation and release of TNFα can be responsible for the anti-inflammatory effects of tea consumption” (see page 2 part 2).
Therefore, it would have been obvious to persons having skill in the art to create the instant invention by selecting an extract of Curcuma longa and an N-acylated amino acid such as SNAC because as Coulter teaches, curcumin which is an extract of Curcuma longa has multiple benefits such as reducing nephrotoxicity and increasing effectiveness in IBD. Additionally, SNAC is taught as a permeability enhancing agent and will help with making curcumin more bioavailable. It would have also been obvious to include vegetable matter from Camellia sinensis because as Oz explains polyphenols from green tea are known to inhibit NF-κB and the release of proinflammatory TNFα and is suggested as a treatment for IBD. Thus including an additional plant component with the same activity for inhibiting NF-κB and thus helping to treat IBD would have been prima facie obvious as both pieces of art direct one to the same treatments via the similar mechanisms.
Claims 71, 74-78 and 80-82 are rejected under 35 U.S.C. 103 as being unpatentable over Coulter (WO2008122967A2) and Helieh Oz, (Chronic Inflammatory Diseases and Green Tea Polyphenols, Nutrients, 9(6) 561, 01-Jun-2017) of claims 66, 68-72 and 79, further in view of Masataka Morishita et. al. (FR2509175A1).
Coulter and Oz teach the herbal composition formulated for oral delivery comprising an extract of Curcuma longa and an N-acylated fatty amino acid and vegetable matter as Camellia sinensis, however is silent on wherein the X and Z positions are other cations such as calcium, magnesium and/or ammonium.
Morishita teaches of therapeutic preparations with excellent absorption properties which comprises of N-acylated amino acids and derivatives (see claim 1) and teaches wherein the N-acylated amino acid derivatives can preferably be alkali metal salts such as sodium salts, potassium salts or ammonium salts (see page 13, line/para. 7).
Therefore, it would have been obvious to a person having ordinary skill in the art at the effective filing date to create an oral formulation with improved bioavailability comprising curcumin and SNAC because Coulter teaches that curcumin can act as an antioxidant and also teaches wherein SNAC is used to maximize permeability of the active substance, both of which are taught in a single embodiment.
It would have also been obvious to substitute the X and Z positions with other cations such as calcium, magnesium and/or ammonium because these compositions would still bear similar structures with functions that would be predicted to be the same or nearly the same as already described in the prior art. For example, each position would be replaced with a cation which each has a positive charge and is able to relinquish at least one proton. Additionally, the MPEP 2144.09 section II states “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 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.)”.
Also, MPEP 2144.09 section III recites “Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979) (Claimed and prior art compounds were both directed to heterocyclic carbamoyloximino compounds having pesticidal activity. The only structural difference between the claimed and prior art compounds was that the ring structures of the claimed compounds had two carbon atoms between two sulfur atoms whereas the prior art ring structures had either one or three carbon atoms between two sulfur atoms. The court held that although the prior art compounds were not true homologs or isomers of the claimed compounds, the similarity between the chemical structures and properties is sufficiently close that one of ordinary skill in the art would have been motivated to make the claimed compounds in searching for new pesticides.).
Furthermore, Morishita teaches of N-acylated amino acid derivatives which can be substituted with the cations; calcium, magnesium and ammonium. Therefore the art recognizes that derivatives of the same nature or at least having the same charge would be functional derivatives.
There would have been a reasonable expectation of success in creating the instant invention because SNAC is well known in the art as a permeability enhancer and as Coulter teaches it can enhance the permeation of active substances. Additionally, Coulter lists curcumin as an active antioxidant and nuclear kappa B inhibitor, or as an active component which can reduce nephrotoxicity, or increase effectiveness in treating inflammatory bowel disease, or to enhance efficacy in the treatment of diabetes-related kidney disorders. It would be expected that replacing the X and Z cations as claimed with other cations would not substantially change the permeable enhancing structure chemically enough to render it unenabled because the compounds being claimed are homologous and still require the same carbon chain backbone and have the same basic structures and functional groups.
Response to Arguments
Applicant's arguments filed 08/20/2025 have been fully considered but they are not persuasive. The applicant argues the prior art does not teach any of the claimed vegetable matter as newly amended in claim 66. The Office relies on new art from Oz to teach including Camellia sinensis which could act to treat IBD an on similar pathways as the primary reference teaches which make combining them together prima facie obvious.
Conclusion
Currently no claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655