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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 28 April 2026 has been entered.
Status of the Claims
Claims 2-4, 6-8, 13, 14, 17, 19-23, 28 and 30-37 have been cancelled.
Claims 9-12, 27 and 29 have been withdrawn.
New claims 40-44 have been submitted.
Claims 1, 5, 15-16, 18, 24-26 and 38-44 are presented for examination on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, 15-16, 18, 24-26 and 38-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has been amended to include the language “wherein the COX-2 associated condition is pain, and wherein the pain is not caused by inflammation”. Presumably this is intended to make the claims directed to a method of treating pain, but not inflammation. However, the specification does not provide support for such a distinction, indeed the specification provides an extensive discussion of the anti-inflammatory properties of honey mediated by COX-2 inhibition.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 5, 15-16, 18, 24-26 and 38-44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rendered vague and indefinite by the phrase “wherein the COX-2 associated condition is pain, and wherein the pain is not caused by inflammation”.
Does this mean that there is no inflammation? Pain and inflammation are typically results of injury, so does this mean that there is an injury without inflammation?
Who is the subject group: A subject suffering from pain associated with COX-2? Someone without inflammation? But as Applicant states in the specification:
COX-2 is known as a proinflammatory enzyme and plays an important role in the regulation of several inflammatory and pain related conditions.
Appropriate clarification is required.
Note: “[W]here there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 35 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 USC 103 should not be based on considerable speculation about the meaning of terms employed in a claims or assumptions that must be made as to the scope of the claims.” MPEP 2173.06 II.
However, in order to practice compact prosecution and to expedite examination of the Application, the claims as drafted are given there broadest reasonable interpretation in light of the specification. 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 pain. 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 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, 5, 15-16, 18, 24-26, 38, 39 and 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over the prior art such as Chi (2017) [cited by Applicant in IDS filed by Applicant 8/15/23].
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).
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.
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, 5, 15-16, 18, 24-26 and 38-44 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.
Response to Arguments
Applicant’s amendments/arguments, with respect to the rejection(s) of the claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the amendments made.
While the claims have been 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 language “wherein the ameliorating or treating comprises inhibiting COX-2 expression” 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.”).
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. Applicant has found that Lepteridine, a specific extract of honey with high concentration of 3,6,7-trimethyllumazine could have efficacy in treating inflammation; however, the claim scope is simply too broad an encompasses manuka honey itself which can contain lepteridine in amounts ranging from 0 to 43.3 mg/kg as shown by Lin et al. (2020) [cited by Applicant in IDS filed 8/15/23]. Thus manuka honey itself is a composition that comprises 3,6,7-trimethyllumazine in a concentration of up to 43.3 mg/kg.
Conclusion
No claims are allowed.
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
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