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 .
The amendment filed 26 November 2025 is acknowledged and has been entered.
Status of the Claims
Claims 3, 6, 7, 13, 14, 17, 19-23, 28 and 30-37 have been cancelled.
Claims 9-12, 27 and 29 have been withdrawn.
Claims 1, 4-5, 8, 15-16, 18, 24-26 and 38-39 are presented for examination on the merits.
Applicant’s amendments with respect to the 35 USC 112(a) rejection have been fully considered and are persuasive. The 35 USC 112(a) rejection of the previous Office action has been withdrawn.
Applicant's amendments/arguments filed with respect to the prior art rejections have been fully considered but they are not persuasive.
While the claims have been extensively amended, as amended the composition containing 3,6,7-trimethyllumazine (i.e., Lepteridine™) could be any of a-d, which means that the any composition containing synthetic 3,6,7-trimethyllumazine or obtained from honey would be within the scope. Indeed Manuka honey itself is not necessarily excluded depending on its 3,6,7-trimethyllumazine levels, which average about 7.4 mg/kg (see Truong et al.). Furthermore, the added language “wherein the ameliorating or treating comprises inhibiting COX-2” does not effectively limit the claims as such a result is an intrinsic result of said positively recited step of administering the composition (see Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F. 3d 1373 (Fed. Cir. 2003) (a whereby “clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”).
Applicant asserts that the cited prior art does not specifically disclose or suggest the compound 3,6,7- trimethyllumazine. Moreover, it does not identify said compound, or any lumazine compounds as having the ability to inhibit COX-2. None of Gear, Delsano, Neamatallah, McIntyre, or Fogh remedy these deficiencies.
This is unpersuasive. First, 3,6,7-trimethyllumazine (i.e., Lepteridine™) is a well-known bioactive component of manuka honey. Secondly, a composition of matter that is old in the art cannot be patented by one who discovers a previously unknown property of that composition. Titanium Metals Corp. of Am. v. Banner, 778 F.2d 775, 227 U.S.P.Q. (BNA) 773 (Fed. Cir. 1985). While a new use of a known compound can be patented, the use of manuka honey containing 3,6,7-trimethyllumazine (i.e., Lepteridine™) is known for its anti-inflammatory properties.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Note: 3,6,7-trimethyllumazine is an inherent component of Manuka honey. For example, Brimble et al. (WO2017/099612) [cited by Applicant in IDS filed by Applicant 8/15/23] discloses the marker compounds of Leptospermum honeys and nectar, specifically identifying 3,6,7-trimethyllumazine (abstract). ). As well as methods of identifying and quantifying 3,6,7-trimethyllumazine in Leptospermum honeys, Brimble et al. further discloses a method of synthesizing it (Example 3, Example 4, Example 6). Investigations carried out on 27 Leptospermum honey samples confirmed the presence of 3,6,7-trimethyllumazine in all samples in concentrations ranging from 5mg/kg to 52mg/kg (page 21 lines 21-24). Where the source is not specified, any composition which contains 3,6,7-trimethyllumazine will fall within the scope, this includes Manuka honey. Present claims relate to the treatment of COX-2-associated conditions. It is noted that citations disclosing the treatment of conditions known in the art to be associated with any of the relevant mechanisms will be considered to disclose the claimed invention. The substance of the invention resides in the use of Manuka honey for the treatment of various conditions. The aetiological mechanism of the pathologies will be inherent to the disclosures of the treatment of the relevant conditions.
Claim(s) 1, 4, 8, 16, 24, 38 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gear (US2011/0038945). [cited by Applicant in IDS filed by Applicant 8/15/23]
Gear discloses the treatment of heartburn and acid reflux with an orally ingestible blend of a vinegar and bioactive honey (abstract, [0094]-[0102], [0327]-[0328]). The bioactive honey is selected from honeys having a recognized substantial antibacterial activity in situ, such as fortified honey, ordinary Manuka honey and active Manuka honey ((0141], [0196], [0215]). In the worked examples, active Manuka honey is used ([0280]).
Thus, the cited reference is deemed to anticipate the cited claims.
Claim(s) 1, 4, 8, 16, 24, 38 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Delsano (WO2020/058113). [cited by Applicant in IDS filed by Applicant 8/15/23]
Delsano discloses the use of a composition comprising hyaluronic acid and Manuka-derived products for the treatment of oral health, in particular of the oral mucosa and gingival walls (abstract). In particular, diseases of the oral cavity include gingivitis, periodontitis, mucositis and gum ulcers (page 9 lines 7-9). The Manuka-derived products are selected from Manuka honey, manuka essential oil
and mixtures thereof (page 4 lines 7-9, page 4 lines 18-21, page 5 lines 14-17). Manuka honey is produced by bees that collect nectar from Manuka flowers and Manuka essential oil is extracted from leaves and twigs by steam distillation (page 4 lines 18-24,
page 5 lines 14-21).
Thus, the cited reference is deemed to anticipate the cited claims.
Claim(s) 1, 4, 16, 24, 38 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neamatallah et al. (2018). [cited by Applicant in IDS filed by Applicant 8/15/23]
Neamatallah et al. discloses the protective effects of Manuka and Talh honeys against cisplatin-induced hepatic and renal toxicity through the inhibition of NF-KB-mediated COX-2 expression (abstract). Manuka honey is described as a unifloral honey with many biological effects, including antibacterial, antioxidant and antiulcer activities (page 3743 right column paragraph 2). Manuka honey prevented cisplatin-induced histopathological changes in the liver and decreased the changes seen in the kidneys (page 3749 left column paragraph 1).
Thus, the cited reference is deemed to anticipate the cited claims.
Claim(s) 1, 4, 16, 24, 38 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McIntyre et al. (AU2003/200927). [cited by Applicant in IDS filed by Applicant 8/15/23]
McIntyre et al. discloses a honey composition comprising 95-99% honey and 1-5% oil (abstract). The use of Manuka honey from the Leptospermum scoparium tree is preferred (page 4 lines 13-15). The oil may be natural, therapeutic, aromatherapeutic, essential or synthetic, and is preferably sandalwood oil (page 3 lines 14-20). The composition may be used against certain microorganisms, including Helicobater pyloris, in the treatment of burns and wound infection (page 5 lines 13-16, page 5 lines 19-20, page 8 lines 9- 6).
Thus, the cited reference is deemed to anticipate the cited claims.
Claim(s) 1, 4, 8, 16, 24, 38 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fogh et al. (2016). [cited by Applicant in IDS filed by Applicant 8/15/23]
Fogh et al. discloses the treatment of esophagitis-related pain using Manuka honey (abstract). Manuka honey was delivered as liquid honey or in dehydrated lozenge form (pages 787-788 bridging paragraph). Both liquid honey and lozenge form erformed comparatively to standard supportive care (page 792 right column paragraph 2). A point of difference was the use of opioids to manage pain at 4 weeks during treatment, where more patients on the supportive care arm were taking opioids (page 793 left column paragraph 1).
Thus, the cited reference is deemed to anticipate the cited claims.
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.
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.
Claim(s) 1, 4-5, 8, 15, 16, 18, 24-26 and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over the above cited prior art in view of Waer et al. (WO200045800). [cited by Applicant in IDS filed by Applicant 8/15/23]
From the prior art it is clear that Leptospermum honeys have many popular uses and clinically tested uses which encompass the conditions listed in the present claims and the prior art clearly identifies 3,6,7-trimethyllumazine as a biomarker for Manuka honey. Further to this, while dependent claims are directed to the fortification and selection of compositions, it is common practice in the art to verify the active content in a naturally sourced product and ensure fractions with the required amounts of the active are taken.
Therefore, these claims merely relate to common practices in the art.
Waer et al. discloses lumazines for the treatment of autoimmune disorders (abstract). The lumazines encompass 3,6,7-trimethyllumazine as presently claimed (page 3 line 4 — page 4 line 8). Autoimmune disorders include systemic lupus erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, ulcerative colitis and juvenile diabetes (page 21 line 23 — page 22 line 2, page 22 lines 31-36). In preparing medicaments, the lumazine compounds will be present at 0.01-50%wt of the composition, preferably within the range of 0.1-5% (page 24 lines 8-18).
It is noted that autoimmune diseases variously involve COX-2, and would therefore be considered conditions associated with these markers.
While Waer et al. does not explicitly synthesize 3,6,7-trimethyllumazine, the compound falls within the scope of the general formula of lumazines defined therein. Therefore, a person skilled in the art would, in seeking to find suitable candidates, come across 3,6,7- trimethyllumazine as a matter of course.
Note the source of the active agent does not contribute to any inventiveness. It is common in the art to source active compounds from natural sources if it is readily available in a useable form. Alternatively, if it is more economical to synthesize the compound, this can also be done. It is noted that the present specification describes no
surprising result or difficulties for a person skilled in the art to overcome in sourcing 3,6,7-trimethyllumazine from any particular source.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40oC and 80oC and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100oC and an acid concentration of 10%); See also, Peterson, 315 F.3d at 1330, 65 USPQ 2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references where held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ 2d 1843 (Fed. Cir.), cert denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ 2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ 2d 1362 (Fed. Cir. 1997).
Accordingly, the instant claims, in the range of proportions where no unexpected results are observed (i.e., evidence of criticality regarding recited dosages), would have been obvious to one of ordinary skill having the above cited references before him/her.
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, 4-5, 8, 15, 16, 18, 24-26 and 37-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-40 and 42-45 of copending Application No. 17/619575 in view of Chi (2017) [cited by Applicant in IDS filed by Applicant 8/15/23].
The instant Application claims a method for treating COX-2 associated conditions or COX-2 associated inflammation by administering a composition comprising 3,6,7-trimethyllumazine. The reference application claims that the 3,6,7-trimethyllumazine is from Leptospermum (Manuka) honey and is administered in concentrations and formulations which overlap with those in the current claims. Chi teaches that Manuka honey is useful for inhibiting COX-2 and MMP-9 and is useful for treating conditions associated with both (see page 83, 102, and 114). Thus, an artisan of ordinary skill would reasonably expect that the method taught by Appl. No. ‘575 would also be useful for treating COX-2 associated inflammation. This reasonable expectation of success would have motivated the artisan to modify Appl. No. ‘575 to include the treatment of COX-2 associated inflammation.
This is a provisional nonstatutory double patenting rejection.
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.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655