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 .
Status of the Claims
Claims 1-16 previously were canceled; claims 22 and 26 are newly canceled. Claims 17-21, 23-25, and 27-32 remain under examination as amended.
Withdrawn Rejections and Response to Arguments
Applicant’s arguments filed 12/29/2025 (hereafter, “Remarks”) have been fully considered and are addressed as follows. All rejections of claims 22 and 26 are withdrawn in view of Applicant’s cancelation of these claims. Support is found in the specification as filed for the claim amendments.
Regarding the previously issued rejection of claims 17-32 under 35 U.S.C. 112(b), Applicant argues that “long-acting” and “cannabidiol” are clear terms and notes the amended claim language. Applicant also argues that “about” is definite even though the term is not defined in the specification as filed, and Applicant cites the range of “about 60% to about 90% w/w” and argues that it is “clear to encompass the range commonly recognized as effective at being biocidal”. In reply, this argument is not persuasive in the current context because the metes and bounds of ranges with “about” coupled to endpoints are unclear and may vary from one artisan’s interpretation to another. Moreover, an ingredient may be included for a different purpose and still render obvious the claimed invention, so the functional role while inseparable from a chemical compound included in a composition is not necessarily further limiting. Applicant’s citation of case law and CDC guidance on pages 5 and 6 of Remarks is noted, however these citations do not offer a standard definition as to the metes and bounds of the claimed terminology, therefore Applicant’s argument is not persuasive. As to Applicant’s subsequent arguments regarding the meaning of the term “biocidal”, this term meaning is understood to be broad but not indefinite. Accordingly, the rejections under 35 U.S.C. 112(b) are maintained as applicable to the claims as amended.
Regarding the rejection of claims 17-24 and 27-32 under 35 U.S.C. 103 as being obvious over Xie, Applicant argues that the claimed invention is not obvious over the cited reference. Applicant’s citation of MPEP guidance and case law as well as Applicant’s characterization of the Xie reference as outlined on page 7 of Remarks are noted. Applicant continues on page 9 that Xie does not supply rationale for modifying its examples and arriving at the claimed invention. This argument is not persuasive because Xie is not limited to a teaching of its examples, and there is no criticality established in the instant case. Moreover, the secondary reference King-Smith provides rationale as to the relatively increased amount of propylene glycol.
On pages 10 and 11 of Remarks, regarding the King-Smith reference, Applicant argues that this teaching pertains to topical formulations comprising ibuprofen and other components in a formulation that reversibly reduces the skin barrier among other King-Smith teachings which Applicant delineates. Applicant concludes that a “skilled person” would not have used King Smith’s high penetrating components in a formulation which would have been likely to lose its desired biocidal activity (see argument in paragraph bridging pages 10 and 11 of Remarks). In reply, Applicant’s argument has been considered but is not persuasive in view of the teachings considered as a whole for what they reasonably would have suggested to the ordinary artisan and also since arguments of counsel (“will likely lose”) cannot take the place of evidence in the record. The relevance of King-Smith is maintained as applied below to the claims as amended.
Accordingly, the rejections of claims 17-24 and 27-32 under 35 U.S.C. 103 as being unpatentable over Xie and subsequently the rejection of claims 25 and 26 further in view of King-Smith are withdrawn in view of the claim amendment particularly narrowing the scope of the propylene glycol content. New grounds of rejection necessitated by amendment are presented below.
Maintained Rejections
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 17-21, 23-25, and 27-32 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. The metes and bounds of the word “about” when coupled with endpoints of numerical ranges is unclear. See claims 17, 18, 21, 23, 24, 27, 29, and 32. The specification does not define this term.
Appropriate clarification is required.
New Grounds of Rejection Necessitated by Amendment
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 17-21, 23-25, and 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over CN112294709A (“Xie”, translation provided by Applicant concurrent with IDS foreign document citation dated 8/23/23 in the file wrapper, previously cited) in view of WO2011/063531A1 (“King-Smith”, previously cited).
The instant claims are drawn to a composition comprising 0.1 to 5% w/w CBD; a lower alcohol having from 2 to 4 carbon atoms in an amount of from about 60% toa bout 90% w/w; from 2 to 25% w/w of a CBD solubilizing agent; and not lower than 1% water, wherein said CBD solubilizing agent is miscible with the lower alcohol and wherein said composition is a long-acting biocide. The functional property or effect of being “a long-acting biocide” is considered an inseparable property of the composition itself or its method of use itself. The claims are further drawn to a method of preparing the same composition.
Xie teaches topical formulations with anti-inflammatory and antioxidant effects. The formulations comprise 0.01-6% cannabidiol, 50-80% of an active component for disinfectant efficacy, 0.12% thickening agent , 0.5-5% humectant, 0.5-3% neutralizer, 0.3-4% of a skin care agent, 0.2-2% of essence, and a balance of water (see abstract, in particular). Xie’s Example 6 starting at [0074] discloses aqueous ethanolic (hydroalcoholic) formulations for hand sanitization (topical application) comprising 0.01% by weight CBD, 80% ethanol, 2% propylene glycol (solubilizing agent), and 9.99% water (see [0076]). Liquid as instantly claimed encompasses a gel as in Xie, and Xie reasonably teaches the stepwise combination of the aforementioned components.
Because Xie’s example does not teach each amount recited in claim 17 in a single embodiment, this rejection is made using obviousness rationale. Xie considered as a whole teaches ranges of formulation components overlapping with those of Xie’s example and including values instantly claimed. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to perform routine optimization procedures within the parameters Xie suggests with a reasonable expectation of success, including arriving at values instantly claimed and ranges instantly claimed. One would have been motivated to do so as part of routine inquiry for optimizing benefits. Moreover, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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).
Regarding claim 18, Xie’s range of CBD overlaps the instantly claimed range.
Regarding claim 19, Xie teaches ethanol in Example 6.
Regarding claim 20, Xie teaches isopropanol as an equivalent alcohol disinfectant active to ethanol (see [0014]).
Regarding claim 21, Xie’s example anticipates the claimed range.
Regarding claim 23, Xie’s Example 6 teaches propylene glycol in an amount within and overlapping the claimed range of “about 3% to 25%”.
Regarding claim 24, Xie’s Example 6 water amount anticipates the claimed range of water.
Regarding claim 27, the amounts recited have been addressed above and are present in overlapping ranges.
Regarding claim 28, Xie teaches a function such that Xie’s composition is used for the very same purpose as recited in claim 28, as detailed above.
Regarding claim 29, Xie teaches an overlapping range of CBD.
Regarding claim 30, Xie teaches ethanol in Example 6.
Regarding claim 31, Xie teaches the same component addressed above in regard to claim 27, and a product and its properties are considered inseparable.
Regarding claim 32, Xie teaches the provision and mixing of components outlined above and for the preparation of a biocide composition as detailed in the claim.
Regarding claims 17, 25, 27, and 32, the amounts of formulation components are addressed above, except the 20% w/w or from 2 to 25% by weight of propylene glycol. Xie’s example includes less propylene glycol as a moisturizing agent for the topical formulation providing anti-inflammatory benefits. Xie does not specify dynamic viscosity characterization.
King-Smith cures this deficiency. Like Xie, King smith teaches topical formulations also providing anti-inflammatory benefits (see [0003] and [0019] in particular). King-Smith’s formulations are hydroalcoholic formulations specifically formulated for topical administration (see [0014]) particularly utilizing ethanol and/or isopropanol (see [0092] for instance). Propylene glycol is included in an amount for instance of about 0% to about 20% or “about 15%” (see [0093]) as an important lower alcohol solvent component (see King-Smith claims 32-35). King-Smith teaches this component to produce improved penetration benefits as a cosolvent (see [0007]).
Xie and King-Smith are both directed to topical hydroalcoholic formulations comprising an agent which provides skin benefits such as anti-inflammatory and/or moisturizing efficacy. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to increase the amount of propylene glycol from the relatively low amount included in Xie’s formulation examples to a value within King-Smith’s generally disclosed range, with a reasonable expectation of success. One would have been motivated to do so to provide penetration benefits and cosolvent benefits as suggested by King-Smith in a similar hydroalcoholic topically applicable composition.
As to the dynamic viscosity being between 0.8 and 3.05 cP at 20 degrees Celsius, Xie does not specify this characteristic. King-Smith cures this deficiency. King-Smith specifies that the composition may have a dynamic viscosity for instance of at most about 2, 3, 4, 5, etc. at STP, a value range overlapping the instantly claimed range (see [00120]) such that one would have been motivated to choose a lower dynamic viscosity characteristic for a topically applicable formulation in order to provide the desired topical feel and features such as adhering to eh skin, spreading ability, drying quickly, and absorbing as desired, all of which King-Smith specifies may be adjusted to provide desirable advantageous characteristics (see [00119]). King-Smith’s teaching of dynamic viscosity upper limits indicates suitable characteristics adjustable in a liquid gel formulation for topical application as is customary in the art.
Conclusion
No claim is allowed at this time.
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.
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/AUDREA B CONIGLIO/ Primary Examiner, Art Unit 1617