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 .
Applicant’s arguments, filed 03 March 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 103 (maintained)
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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over LaRosa et al. (US 2021/0093724 A1, 04/01/2021, filing date 07/14/2020) (hereinafter LaRosa).
LaRosa discloses a topical composition comprising: solvent, emulsifier, thickening agent, emollient, and a cannabinoid (clm 1) such as cannabidiol (CBD) ([0020]). The cannabinoid may be 0.01 to 10 wt. % ([0735]). The solvent is present in 60-80 wt. % (clm 7) and includes water (cim 6). The emulsifier is present in 3-8 wt. % (claim 9) and includes propylene glycol (clm 8). The emollient is present in 10-22 wt. % (clm 13) and includes petrolatum (petroleum jelly) (clm 12). The thickening agent is present in 0.3-3 wt. % (clm 11) and includes cetearyl alcohol (clm 10). The composition may further comprise a pH adjust agent such as citric acid (clm 16) and a transdermal delivery agent including Transcutol® (2-(2-ethoxyethoxy)ethanol) (i.e. claimed diethylene glycol monoethyl ether) (clm 18). The composition has a pH of 4.0-7.0 (clm 25) and may be formulated as a cream ([0042]).
As noted by para. [080] of the instant Specification, propylene glycol is a humectant.
Thus, LaRosa discloses compositions having a pH of 4.0-7.0 (clm 25) containing 0.01-10% wt. ([0735]) of CBD ([0020]); 3-8 wt. % (clm 9) of propylene glycol (clm 8); 2-(2-ethoxyethoxy)ethanol as transdermal delivery agent (clm 18); 60-80 wt. % (clm 7) of water; 0.3-3 wt. % (clm 11) of cetearyl alcohol as thickening agent (clm 10); and citric acid as a pH adjusting agent (clm 16). Together these would provide compositions as claimed instantly.
The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding the recited amounts of cannabinoid, humectant, and thickening agent, the claimed amounts (i.e. 0.01-10% (w/w), 0.01-10% (w/w), and 1-10% (w/w), respectively) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 0.01-10 wt. %, 3-8 wt. %, and 0.3-3 wt. %, respectively). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claims 1, 4, 12 and 16 reciting amounts of water, the claimed amounts (i.e. to make up 100% by weight, or no less than 31% (w/w)) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. 60-80 wt. %). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding the recited amounts of penetration enhancer, since LaRosa discloses 2-(2-ethoxyethoxy)ethanol (i.e. claimed diethylene glycol monoethyl ether) as a transdermal delivery agent, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed amount of penetration enhancer (i.e. 1-5% (w/w)) through routine experimentation based on the level of transdermal delivery effect desired. "[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 1-3 reciting less than 40% (w/w), no more than 10% (w/w), and no more than 1% (w/w) ethanol, respectively, the amounts would have been obvious to one of ordinary skill in the art since LaRosa does not disclose wherein ethanol is a required component.
Regarding claim 5, as noted by para. [0126] of the instant Specification, cannabidiol has a molecular weight of 314.46 g/mol and propylene glycol has a molecular weight of 76.09 g/mol. Therefore the propylene glycol of LaRosa meets the limitations of having a lower molecular weight than the molecular weight of cannabinoid as instantly claimed.
Regarding claim 16 reciting a cannabinoid localizing agent, paragraph [070] appears to suggest a combination of humectant and penetration enhancer serves as a cannabinoid localizing agent. Accordingly, the propylene glycol and 2-(2-ethoxyethoxy)ethanol of LaRosa meet the limitation of a cannabinoid localizing agent as claimed.
Regarding claim 17 reciting a viscosity range, LaRosa does not explicitly disclose a viscosity range. However, since the topical compositions of LaRosa are in the dosage form of a cream and comprise substantially the same components (i.e. cannabinoid, propylene glycol, 2-(2-ethoxyethoxy)ethanol (i.e. diethylene glycol monoethyl ether), and water) in substantially the same amounts, one of ordinary skill in the art would reasonably conclude the composition of LaRosa to have a viscosity of about 20,000 – 100,000 cps like the claimed invention.
Response to Arguments
Applicant mainly asserts that LaRosa discloses not specifically disclose or suggest using propylene glycol as a humectant, and that, even though propylene glycol is known to a person of skill in the art to have multiple uses, the Examiner is improperly relying on inherency because it cannot demonstrate that propylene glycol necessarily is useful as humectant when used in combination with the excipients taught by LaRosa. Therefore, the Examiner improperly used the instant application as a template to piece together the claimed combination of using propylene glycol as a humectant.
The Examiner does not find the Applicant’s assertions to be persuasive. The rejections do not rely on inherency to support the context of obviousness. The Examiner is simply pointing out that propylene glycol is considered a humectant according to the instant Specification, thus LaRosa’s disclosure, comprising propylene glycol, meets the limitation of a “humectant” as instantly claimed. Moreover, it is not clear to the Examiner how calling the same substance a humectant, an emulsifier, a solvent, or another name, would alter the chemical compound itself. It is noted the instant claims are directed to a composition. Where the components of the composition are taught by the prior art, as long as the component is present in the composition made obvious, there is a reasonable expectation that the functional limitations regarding such a composition are also met, given that the function of a composition is a product of the compositions’ structure. In other words, the component need not be included for the same purpose as Applicant’s reasoning. In this case, since the composition of LaRosa discloses substantially the same propylene glycol, it would be usable as a humectant whether the prior art recognizes such use or not. As such, Applicant’s assertion is unpersuasive.
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,343,315 in view of LaRosa et al. (US 2021/0093724 A1, 04/01/2021, filing date 07/14/2020) (hereinafter LaRosa). The patented claims differ from the instant claims insofar as not reciting wherein the skin conditioning agents comprise propylene glycol. However, LaRosa discloses a topical composition comprising: solvent, emulsifier, thickening agent, emollient, and a cannabinoid (clm 1) such as cannabidiol (CBD) ([0020]). The cannabinoid may be 0.01 to 10 wt. % ([0735]). The emulsifier includes propylene glycol (clm 8). Accordingly, it would have been obvious to one of ordinary skill in the art to have included propylene glycol in the topical composition of the patented claims since it is a known and effective skin conditioning agent as taught by LaRosa.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,064,461 in view of LaRosa et al. (US 2021/0093724 A1, 04/01/2021, filing date 07/14/2020) (hereinafter LaRosa). The patented claims differ from the instant claims insofar as not reciting wherein the emulsifier comprise cetearyl alcohol. However, LaRosa discloses a topical composition comprising: solvent, emulsifier, thickening agent, emollient, and a cannabinoid (clm 1) such as cannabidiol (CBD) ([0020]). The cannabinoid may be 0.01 to 10 wt. % ([0735]). The emulsifier includes cetearyl alcohol (clm 8). Accordingly, it would have been obvious to one of ordinary skill in the art to have included cetearyl alcohol in the topical composition of the patented claims since it is a known and effective emulsifier as taught by LaRosa.
Response to Arguments
Applicant does not present specific arguments with regard to LaRosa and the patented claims.
Since the Examiner has discussed LaRosa above, these rejections are maintained.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
LaRosa et al. (US 2021/0093539 A1, 4/1/2021) is directed to a topical cosmetic composition including an external cosmetic agent, pharmaceutically acceptable excipients, and cannabinoids.
Yerike (US 2019/0282513 A1, 09/19/2019) is directed to topical compositions, including creams, for use in relief of pain, comprising cannabidiol (CBD) powder, ethoxydiglycol as a solvent and penetration enhancer, water, and emulsifier.
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 TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights