DETAILED ACTION
Applicant’s arguments, filed 12 May 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Claim Objections (New)
Claim 4 is objected to because of the following informalities: “a ratio of active ingredients that is equivalent to a ratio of active ingredients that is:” in lines 2-3 of the claim appears to be redundant and should be recited as --- a ratio of active ingredients that is: ---. Appropriate correction is required.
Applicant is advised that should claim 3 be found allowable, claim 10 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 claim 1, the transitional phrase “consists essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s) of the claimed invention” (See MPEP 2111.03(III)). Applicant has not made clear in the instant specification or instant claims any component such as compounds, adjuvants, or additives wherein the addition of such component would constitute a material change in the basic and novel characteristics of the claimed invention or cause a deleterious effect to the claimed invention. Therefore, for the purposes of searching for and applying prior art under 35 U.S.C. 103, "consisting essentially of" will be construed as equivalent to "comprising."
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).
Response to Arguments
Applicant mainly asserts neither paragraph [0078] or Table 2 in Czap discloses a cyclodextrin consisting essentially of the specific components as defined by the amended claims. Thus, Czap and Kindel, individually or together, fail to provide the required motivation to combine or assemble the particular CD inclusions recited in claim 1.
The Examiner does not find Applicant’s assertion to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. As discussed in the rejection, Kindel provides known and effective plant extracts suitable for forming CD inclusion complexes, such as those of Czap. As supported by MPEP § 2144.07, 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. Moreover, as discussed in the rejection above, Czap discloses CD inclusion complex mixtures with various guest molecules that are matched in size/affinity. As supported by MPEP § 2123, a prior art reference is evaluated for all that it reasonably suggests and is not limited to preferred embodiments and working examples. Therefore, the teachings of Czap are not limited to Table 2 or paragraph [0078] and Applicant’s assertion is unpersuasive. Finally, as discussed in the rejection above, the transitional phrase “consisting essentially of” will be construed as equivalent to “comprising” as Applicant has not made clear in the instant Specification or instant Claims any component wherein the addition of such component would constitute a material change in the basic and novel characteristics of the claimed invention or cause a deleterious effect to the claimed invention. See MPEP § 2111.03(III). As such, Applicant’s assertion is unpersuasive.
Applicant further asserts the pending claims define a specific formulation that has shown surprising physiological efficacy. In particular, in Example 5 of the present application, the claimed formulation shows mucoactive effects in treating a viral pneumonitis.
The Examiner does not find Applicant’s assertion to be persuasive. It is unclear to the Examiner, based solely on the subjective data provided in Example 5 (e.g., improvement in the patient’s sense of well-being), how the instantly claimed composition provides an unexpected improvement. Regarding potential evidence of unexpected results, Applicant has the burden of explaining the data in any declaration they proffer as evidence of non-obviousness. MPEP § 716.02(b)(II). Note that factually uncorroborated assertions (such as those referenced in the Specification) cannot take the place of evidence in the record. See MPEP § 716.01 (c)(Il). Moreover, any differences between the claimed invention and the prior art may be expected to result in some difference in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The burden is on applicant to establish that the results are in fact really unexpected and of statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992). See also MPEP § 716.02. Applicant does not appear to have discussed same with respect to objective data in the working examples.
Finally, assuming purely arguendo that unexpectedness of the results has been established, the probative value of the evidence as compared to the invention as claimed must then be determined, i.e., the claims must be “commensurate in scope” with the showing. MPEP § 716.02(d). See also MPEP § 2145. Applicant must explain the “manner in which the specific compositions illustrated are considered to be commensurate in scope with the claimed invention”; see Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992); see also MPEP 716.02, citing same. Example 5 of the instant Specification employ specific components in specific amounts in mg, and even if Applicant were to show unexpected results, they would have been obtained, for example, not with the broad class of “eucalyptol beta CD inclusion; a camphene beta CD inclusion; a carene delta 3 beta CD inclusion; a guaiol gamma CD inclusion; a peppermint oil beta CD inclusion; a fenugreek extract gamma CD exclusion” or “a cyclodextrin degrading enzyme” generally, but instead with specific species of same. Note, for example, Example 5 of the instant specification uses extract of Eucalyptus myrtaceae containing eucalyptol 6mg in beta CD inclusion complex and amylase 7mg as the “eucalyptol beta CD inclusion” and “cyclodextrin degrading enzyme”, respectively. Applicant would need to explain how these specific species are “reasonably representative” of the more broadly claimed subject matter of the claims, even were the results persuasively demonstrated to be “in fact really unexpected and of statistical and practical significance”.
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 disclosures 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).
Response to Arguments
Applicant does not present specific arguments with regard to Czap and Bruun.
Since the Examiner has discussed Czap above, this rejection is maintained.
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.
Response to Arguments
Applicant does not present specific arguments with regard to Czap and Patron.
Since the Examiner has discussed Czap above, this rejection is maintained.
Conclusion
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571) 272-. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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