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 . Claims 1-5, 7, 8, 10-13, 75-82, 87-91 are pending; claims 1-5, 7, 8, and 10-13 are examined; claims 75-82 and 87-91 are withdrawn.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-5, 7, 8, and 10-13 in the reply filed on 17 October 2025 is acknowledged. The traversal is on the ground that Applicant disagrees with the Examiner’s characterization of the Kindel reference with regard to its potential relevance to the pending claims. This is not found persuasive because Kindel discloses the common technical feature of cyclodextrin inclusion complexes with the instantly claimed guest molecules contained within. Thus Kindel discloses the common technical feature as instantly claimed.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 2-4 and 10 are objected to because of the following informalities: “wt” in each instance should be recited as --- wt. ---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2-5 and 10-13 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.
Claims 2-4 and 10 recite various weight percentages (% by wt) and/or milligram (mg) in parentheses, which renders the claims indefinite because the scope of the claims is unclear. It is not clear whether the limitations introduced by such parentheses are (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) required limitations of the claim, as some parentheses have the recitation of the phrase “optionally”. For the purposes of examination, where the word “optionally” is not included within the parentheses, the ranges are interpreted to be required. Examiner suggests amending the claims to positively recite the ranges, e.g., --- eucalyptol at 5-15% by weight ---, or --- eucalyptol beta CD inclusion optionally in an amount of 50-100mg ---. Furthermore, the claims are confusing because the terpene ranges are in % by wt. and the CD inclusion ranges are in mass units.
The term “substantially equivalent” in claim 4 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear to what degree of equivalency is considered “substantially” equivalent, such that one of ordinary skill in the art would know whether a ratio of active ingredients would infringe on the claimed invention.
Claim 4 recites wherein the CD inclusion complex formulation comprises a ratio of active ingredients that is substantially equivalent to the ratio of active ingredients in a formulation comprising the active ingredients, which renders the claim indefinite because the scope of the claim is unclear. It is unclear whether the CD inclusion complex formulation is the same formulation referenced in the latter recitation of “a formulation”, and it is further unclear whether the active ingredients of the CD inclusion complex formulation is the same as the active ingredients in the latter formulation. Clarification is requested.
Claims 5 and 11 contains the trademark/trade name “K250”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe “hydroxypropyl methylcellulose” and, accordingly, the identification/description is indefinite.
Claims 12 and 13 are rejected as they depend from claim 11.
Claim Rejections - 35 USC § 103
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 1-5, 7-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Czap (WO 2017/136775 A1, 08/10/2017, IDS reference) (hereinafter Czap) in view of Kindel et al. (US 2007/0297993 A1, 12/27/2007) (hereinafter Kindel).
Czap discloses cyclodextrin (CD) inclusion complex mixtures as delivery vehicles, comprising a plurality of alternative guest molecules forming inclusion complexes with a plurality of alternative CDs, with each of the guest molecules matched in size and/or affinity to a corresponding CD having a cavity sized or adapted to stably retain the guest molecule (abs, [0075]). The delivery vehicles are provided with an enzyme having a CD-degrading activity capable of digesting the CD, so that upon delivery of the vehicle to a target, the enzyme is activated and releases the guest molecule from the CD cavity (abs). The CD may be an alpha, beta or gamma CD ([0018]), and the guest molecules include eucalyptol, camphene, guaiol and carene ([0078]) including delta-3-carene (Table 2). The CD inclusion complexes may be made with plant extracts ([0064]). The enzyme includes amylase ([0012]). The delivery vehicles may be provided in combination with a pharmaceutically acceptable carrier or excipients, including solvents, dispersion media and coatings ([0035]), or formulated for sustained release ([0019]).
Czap differs from the instant claims insofar as not explicitly disclosing wherein the plant extracts include peppermint oil or fenugreek extract.
However, Kindel discloses preparing cyclodextrin inclusion complexes of several odoriferous or aroma substances ([0108], [0137]), including camphene, 3-carene ([0120]), eucalyptol ([0119]), guaiol ([0116]), peppermint oil ([0109]), and compound of formula C found in seeds of fenugreek ([0090]). The odoriferous or aroma substances may be 0.05 to 50 wt. % of the total weight of a formulation ([0070]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included peppermint oil and fenugreek seed extract in the formulation of Czap since each is a known and effective plant extract suitable for forming a CD inclusion complex as taught by Kindel. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07.
Regarding the claims reciting specific structures of CD (i.e., alpha, beta, or gamma CD inclusion), it would have taken no more than the relative skills of one of ordinary skill in the art to have matched the claimed guest molecules to the claimed corresponding CD having a cavity sized or adapted to stably retain the guest molecule through routine experimentation based on the general guidance of Czap. "[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." See MPEP § 2144.05(II)(A).
Regarding claims 2-4 and 10 reciting various amounts of various terpenes in weight percentages, and/or various amounts of each CD inclusion in mg, although Czap does not explicitly disclose amounts of each terpene or CD inclusion, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amounts in mg or weight % through routine experimentation based on the level of effects desired of each terpene and/or CD inclusion. See MPEP § 2144.05(II)(A).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Czap (WO 2017/136775 A1, 08/10/2017, IDS reference) (hereinafter Czap) in view of Kindel et al. (US 2007/0297993 A1, 12/27/2007) (hereinafter Kindel), further in view of Bruun et al. (US 2021/0177748 A1, priority 12/13/2019) (hereinafter Bruun).
The disclsoures of Czap and Kindel have been discussed in detail above, and differs from the instant claim insofar as not explicitly disclosing wherein the sustained release agent comprises hydroxypropyl methylcellulose (i.e. instantly claimed K250).
However, Bruun discloses cyclodextrin complexes with one or more cannabinoids ([0104]), further comprising coating polymers such as edible cellulose derivatives including hydroxypropyl methylcellulose (HPMC) ([0221]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included HPMC in the formulation of Czap, since it is a known and effective polymer suitable for compositions comprising cyclodextrin complexes as taught by Bruun.
Regarding claim 12 reciting an amount of amylase in mg, although Czap does not explicitly disclose an amount of amylase, since amylase is an enzyme controlling the release of guest molecules from the CD inclusion complexes, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amounts of amylase through routine experimentation based on the release rate desired. See MPEP § 2144.05(II)(A).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Czap (WO 2017/136775 A1, 08/10/2017, IDS reference) (hereinafter Czap) in view of Kindel et al. (US 2007/0297993 A1, 12/27/2007) (hereinafter Kindel), further in view of Bruun et al. (US 2021/0177748 A1, priority 12/13/2019) (hereinafter Bruun), and further in view of Patron et al. (US 2017/0087199 A1, 03/30/2017) (hereinafter Patron).
The disclosures of Czap, Kindel, and Bruun have been discussed in detail above, and differs from the instant claim insofar as not explicitly disclosing wherein the composition comprises calcium laurate 5mg.
However, Patron discloses compositions comprising combinations of compounds with one or more terpenes ([0025]) such as guaiol ([0026]); flavorants and additives ([0002]) such as, inter alia, calcium laurate ([0122]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included calcium laurate in the formulation of Czap, since it is a known and effective additive suitable for incorporation into various types of compositions as taught by Patron.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY M TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Friday 10:00 AM - 6:00 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/FREDERICK F KRASS/Supervisory Patent Examiner, Art Unit 1612