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 .
DETAILED ACTION
This action is in response to Applicant’s amendment filed March 24, 2026 in reply to the First Office Action on the Merits mailed November 24, 2025. Claims 1, 2, 7, 12, 19, and 20 have been amended; and claims 3, 11, and 14 have been canceled. Claims 5, 6, 8, 9, and 15-18 have been withdrawn. Claims 1, 2, 4, 7, 10, 12, 13, 19, and 20 are under examination in the application.
Withdrawal of Prior Objection - Drawings
The drawings have been satisfactorily amended on corrected drawing sheets in compliance with 37 CFR 1.121(d). Therefore, the objections to the drawings presented in the First Office Action on the Merits mailed November 24, 2026 are hereby withdrawn.
Withdrawal of Prior Double Patenting Objection
Claim 11 has been canceled. Therefore, the objection to claim 11 under 37 CFR 1.75 as being a substantial duplicate of claim 4 is hereby withdrawn.
Abstract
The abstract of the disclosure is objected to for the following reasons:
1. The abstract should not refer to purported merits or speculative applications of the invention, and should not compare the invention with the prior art. The final sentence of the abstract discloses a potential application of the composition, i.e. as an ingredient in an oil-in-water emulsion. This sentence should be deleted.
Correction is required. See MPEP § 608.01(b).
Claim Objections
Claims 19 is objected to because the expression “(weight-to-weight) w/w ratio” should be “weight-to-weight (w/w) ratio”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Claims 12 and 19 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 12, as now amended, stipulates that the composition further comprises “butylated hydroxytoluene”. The original specification and claims say nothing about “butylated hydroxytoluene”, or even “hydroxytoluene”. This seems to be a case where the acronym only was employed instead of the proper chemical name of a compound. To remedy this, the specification must first be amended to recite “butylated hydroxytoluene”. In order to do that, Applicant must establish that one of ordinary skill in the art at the time the present application was filed would readily understand that “BHT” would be understood to mean “butylated hydroxytoluene”. This can be done by providing suitable references to support the position.
Claim 19, as now amended, stipulates in a wherein clause that “the (weight-to-weight) w/w ratio between the cannabinoid active ingredients in said composition and said alcohol-based oral spray is 1:1.4”. Applicant contends that support for this amendment is found in paragraphs [0082], [0172], and Table 5, which disclose administration of two sublingual tablets versus four sprays of SATIVAX, and that each tablet contains 10 mg cannabinoids, i.e. 20 mg cannabinoids total for two tablets, and each spray of SATIVAX delivers 5.2 mg cannabinoids, i.e. 20.8 mg cannabinoids total for four sprays.
However, claim 19 says nothing at all about tablets containing 10 mg of cannabinoids, about there being two tablets, about 20 mg total cannabinoids for two tablets, about SATIVAX, about there being four sprays, and about 5.2 mg cannabinoids per spray, and about 20.8 mg total cannabinoids for four sprays. Indeed, the present claims are directed to a tablet or a film. Hence, two tablets is not representative of the claimed composition. Hence, claim 19 is far broader in scope than what Applicant actually has support for in their specification.
This constitutes new matter.
Claim Rejections - 35 USC § 112(b)
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 19 and 20 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 19, which depends from claim 1, stipulates in a wherein clause that following sublingual or buccal administration, the plasma level of cannabinoids for the claimed composition “are increased” compared to “an alcohol-based oral spray”, which renders the claim indefinite for the following reasons:
1. Claim 1 is directed to a composition in the form of a tablet or a film comprising THC and/or CBD, vitamin E TPGS, 1-50 mg menthol, and 2-100 mg of a mucoadhesive polymer. Claim 1 is not directed to a method, and does not require the administration of the composition.
2. One of ordinary skill in the art cannot make heads or tails out of the metes and bounds of the claimed subject matter. First, “an alcohol-based oral spray” has nothing at all to do with the claimed composition. The alcohol-based oral spray is undefined and unknown. The amount of cannabinoids in the spray is undefined and unknown. The bioavailability of the cannabinoids in the spray is undefined and unknown. The plasma level of the cannabinoids from administering the spray is undefined and unknown. The plasma level of cannabinoids from the spray is an unknown variable “X” with no real limitations. Hence, the plasma level of cannabinoids from the composition, which is “increased” compared to “X” is also an unknown variable “Y” with no real limitations, other than it must be greater than “X” and hence is not zero.
3. One of ordinary skill in the art cannot definitively ascertain the standard or reference plasma level, in what manner and to what extent the composition’s cannabinoid plasma level is “increased” compared to the spray cannabinoid plasma level, whether the cannabinoids in the composition and the spray are the same, whether the alcohol in the alcohol-based oral spray is menthol, and really what variable is being tested here. Hence, claim 19 appears to be nothing of any meaningful substance as far as limiting the actual claimed composition itself, but merely an arbitrary comparison of apples and oranges, i.e. a relative and meaningless comparison of an undefined and unknown variable “X” with an undefined and unknown variable “Y”, and one of ordinary skill in the art cannot definitively ascertain how claim 19 necessarily limits the composition of claim 1, and cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 20 depends from claim 19, and stipulates that the composition is “characterized by a plasma profile with an AUC at least 150% greater than said alcohol-based oral spray”. The AUC of the alcohol-based oral spray, like the plasma level of cannabinoids, is undefined and unknown. Hence, an AUC of at least 150% of this undefined and unknown variable “X” is effectively meaningless, just another undefined and unknown variable “Y”. Indeed, any AUC could be said to meet this limitation. Just as explained for claim 19, supra, claim 20 appears to be nothing of any meaningful substance as far as limiting the actual claimed composition itself, merely an arbitrary comparison of apples and oranges, with a relative and meaningless comparison of an undefined and unknown AUC value with another undefined and unknown AUC value, and one of ordinary skill in the art cannot definitively ascertain how claim 20 necessarily limits the metes and bounds of the actual claimed composition itself.
Claim 20 is (also) indefinite for depending from an indefinite claim.
Claim Rejections - 35 USC § 103 (I and II)
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 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.
I. Claims 1, 2, 4, 7, 10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Elsohly et al. (U.S. Patent Application Pub. No. 2006/0257463), in view of Purcell (U.S. Patent Application Pub. No. 2013/0337096).
I. Applicant Claims
Applicant’s elected subject matter is directed to a composition comprising THC, CBD, vitamin E TPGS, 1-50 mg menthol, 2-100 mg mucoadhesive polymer including carbomer, and BHT; wherein e.g. the THC can be present in the amount of 0.5-50 mg, wherein the weight ratio of vitamin E TPGS to cannabinoid is at least 1:1, wherein the menthol is in crystal form, and wherein the composition can be in the form of a tablet or film.
I. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Elsohly et al. disclose a composition for oral transmucosal delivery comprising e.g. a cannabinoid active (e.g. THC and CBD), vitamin E TPGS (a surfactant), menthol (i.e. as a permeation enhancer), mucoadhesive polymer including carbomer, and an antioxidant such as BHT; wherein the composition is in the form of e.g. a film (abstract; paragraphs 0001, 0006, 0012-0016, 0021, 0028, 0033; examples; Tables I-III).
Purcell discloses a composition for oral transmucosal delivery comprising e.g. a cannabinoid active, 0.5-15 wt% permeation enhancer e.g. surfactant, 1-5 wt% menthol crystals, mucoadhesive polymer, and a “solubilizer”; wherein the composition can be in the form of a tablet or film, and wherein the composition can be e.g. 35 mg or 2 g (abstract; paragraphs 0018-0021, 0024, 0036-0038, 0042, 0045, 0047, 0056, 0057, 0083, 0090, 0094, 0173, 0228, 0256, 0284).
I. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Elsohly et al. do not explicitly disclose that the amounts of THC, menthol, and mucoadhesive polymer including carbomer are 0.5-50 mg, 1-50 mg, and 2-100 mg, respectively; and that the weight ratio of vitamin E TPGS to cannabinoid is at least 1:1. These deficiencies are cured by the teachings of Elsohly et al. and Purcell.
I. Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Elsohly et al. and Purcell, outlined supra, to devise Applicant’s presently claimed composition.
Elsohly et al. disclose a composition for oral transmucosal delivery of an effective amount of cannabinoid comprising e.g. a cannabinoid active (e.g. THC and CBD), vitamin E TPGS (a surfactant), menthol (i.e. as a permeation enhancer), mucoadhesive polymer including carbomer, and an antioxidant such as BHT; wherein the composition is in the form of e.g. a film. Since Elsohly et al. disclose that THC is present in the amount of e.g. 4-16 wt% (see e.g. examples), and that the mucoadhesive polymers (i.e. including any of polyethylene oxide, carbomer, PVP, cellulose-based polymers and chitosan) are present in the amount of e.g. 79.23 wt% (see e.g. Table 1, TMP-8), and since Purcell discloses that compositions for oral transmucosal delivery of e.g. cannabinoids can be e.g. 35 mg, and contain e.g. 0.5-15 wt% permeation enhancer e.g. surfactant, and about 1-5 wt% menthol crystals, one of ordinary skill in the art would thus be motivated to thus employ a dose of the composition that is 35 mg in mass, and to include e.g. 1.4-5.6 mg THC (i.e. 4-16 wt% of 35 mg), 0.35-1.75 mg menthol (i.e. 1-5 wt% of 35 mg), and 27.73 mg mucoadhesive polymer including carbomer (i.e. 79.23 wt% of 35 mg), with the reasonable expectation that the resulting composition will successfully deliver the effective amount of the cannabinoid via oral mucosa.
Moreover, Elsohly et al. disclose that for a composition for oral transmucosal delivery of a cannabinoid, the THC is present in the amount of e.g. 4-16 wt% (see e.g. examples), and that Vitamin E TPGS is a suitable surfactant. Purcell discloses that for a composition for oral transmucosal delivery comprising e.g. a cannabinoid active, 0.5-15 wt% permeation enhancer e.g. surfactant, is suitable. With 4 wt% cannabinoid, and with a maximal amount of the permeation enhancer e.g. surfactant, i.e. Vitamin E TPGS, i.e. about 15 wt%, to thus maximize the permeation enhancement, one of ordinary skill in the art could thus arrive at a weight ratio of vitamin E TPGS to cannabinoid of 15:4, or 3.75:1, which meets the limitation of “at least 1:1”.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the application was filed, as evidenced by the references, especially in the absence of evidence to the contrary.
II. Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Elsohly et al. (U.S. Patent Application Pub. No. 2006/0257463), in view of Purcell (U.S. Patent Application Pub. No. 2013/0337096), and Pellikaan et al. (U.S. Patent Application Pub. No. 2010/0008985).
II. Applicant Claims
Applicant’s elected subject matter is directed to a composition comprising THC, CBD, vitamin E TPGS, 1-50 mg menthol, 2-100 mg mucoadhesive polymer including carbomer, and BHT; wherein the weight ratio of vitamin E TPGS to cannabinoid is at least 1:1, wherein the composition can be in the form of a tablet or film, and wherein following sublingual or buccal administration, plasma levels of cannabinoid after 6 hours are “increased” compared to “an alcohol-based oral spray”.
II. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Elsohly et al. disclose a composition for oral transmucosal delivery comprising e.g. a cannabinoid active (e.g. THC and CBD), vitamin E TPGS (a surfactant), menthol (i.e. as a permeation enhancer), mucoadhesive polymer including carbomer, and an antioxidant such as BHT; wherein the composition is in the form of e.g. a film (abstract; paragraphs 0001, 0006, 0012-0016, 0021, 0028, 0033; examples; Tables I-III).
Purcell discloses a composition for oral transmucosal delivery comprising e.g. a cannabinoid active, 0.5-15 wt% permeation enhancer e.g. surfactant, 1-5 wt% menthol crystals, mucoadhesive polymer, and a “solubilizer”; wherein the composition can be in the form of a tablet or film, and wherein the composition can be e.g. 35 mg or 2 g (abstract; paragraphs 0018-0021, 0024, 0036-0038, 0042, 0045, 0047, 0056, 0057, 0083, 0090, 0094, 0173, 0228, 0256, 0284).
Pellikaan et al. disclose a composition for oral transmucosal (e.g. sublingual, buccal) delivery comprising cannabinoids such as THC and CBD, an emulsifier that facilitates solubilization and penetration of the active (i.e. cannabinoids), and a mucoadhesive polymer such as carbomer; wherein the composition can be in the form of a tablet, wherein the e.g. THC can be present in the amount of e.g. 1-50 mg, and wherein the composition exhibits greater bioavailability than SATIVEX (i.e. an alcohol-based oral spray having 5.2 mg/spray of cannabinoid actives) (abstract; paragraphs 0017, 0029, 0058-0060, 0064, 0068, 0080, 0087; paragraphs 0125-0138; Table 1).
II. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Elsohly et al. do not explicitly disclose that the amounts of menthol and mucoadhesive polymer including carbomer are 1-50 mg and 2-100 mg, respectively; that the weight ratio of vitamin E TPGS to cannabinoid is at least 1:1; and that the composition has a greater bioavailability than an alcohol-based oral spray. These deficiencies are cured by the teachings of Elsohly et al., Purcell, and Pellikaan et al.
II. Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Elsohly et al., Purcell, Pellikaan et al., outlined supra, to devise Applicant’s claimed composition.
Elsohly et al. disclose a composition for oral transmucosal delivery of an effective amount of cannabinoid comprising e.g. a cannabinoid active (e.g. THC and CBD), vitamin E TPGS (a surfactant), menthol (i.e. as a permeation enhancer), mucoadhesive polymer including carbomer, and an antioxidant such as BHT; wherein the composition is in the form of e.g. a film. Since Elsohly et al. disclose that THC is present in the amount of e.g. 4-16 wt% (see e.g. examples), and that the mucoadhesive polymers (i.e. including any of polyethylene oxide, carbomer, PVP, cellulose-based polymers and chitosan) are present in the amount of e.g. 79.23 wt% (see e.g. Table 1, TMP-8), and since Purcell discloses that compositions for oral transmucosal delivery of e.g. cannabinoids can be e.g. 35 mg, and contain e.g. 0.5-15 wt% permeation enhancer e.g. surfactant, and about 1-5 wt% menthol crystals, one of ordinary skill in the art would thus be motivated to thus employ a dose of the composition that is 35 mg in mass, and to include e.g. 1.4-5.6 mg THC (i.e. 4-16 wt% of 35 mg), 0.35-1.75 mg menthol (i.e. 1-5 wt% of 35 mg), and 27.73 mg mucoadhesive polymer including carbomer (i.e. 79.23 wt% of 35 mg), with the reasonable expectation that the resulting composition will successfully deliver the effective amount of the cannabinoid via oral mucosa.
Moreover, Elsohly et al. disclose that for a composition for oral transmucosal delivery of a cannabinoid, the THC is present in the amount of e.g. 4-16 wt% (see e.g. examples), and that Vitamin E TPGS is a suitable surfactant. Purcell discloses that for a composition for oral transmucosal delivery comprising e.g. a cannabinoid active, 0.5-15 wt% permeation enhancer e.g. surfactant, is suitable. With 4 wt% cannabinoid, and with a maximal amount of the permeation enhancer e.g. surfactant, i.e. Vitamin E TPGS, i.e. about 15 wt%, to thus maximize the permeation enhancement, one of ordinary skill in the art could thus arrive at a weight ratio of vitamin E TPGS to cannabinoid of 15:4, or 3.75:1, which meets the limitation of “at least 1:1”.
Furthermore, because Pellikaan et al. disclose that a composition, e.g. a tablet, for oral transmucosal (e.g. sublingual, buccal) delivery comprising cannabinoids such as THC and CBD, an emulsifier that facilitates solubilization and penetration of the active, and a mucoadhesive polymer such as carbomer; wherein the e.g. THC can be present in the amount of e.g. 1-50 mg, exhibits greater bioavailability than SATIVEX, i.e. an alcohol-based oral spray having 5.2 mg/spray of cannabinoid actives, one of ordinary skill in the art would reasonably expect that the resulting composition comprising 1.4-5.6 mg THC will exhibit a greater bioavailability than SATIVEX, i.e. an alcohol-based oral spray having 5.2 mg/spray of cannabinoid actives.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the application was filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed March 24, 2026 have been fully considered but they are not persuasive.
i) Applicant contends that “the Elsohly examples…disclose Vitamin E TPGS at 3 wt% and THC at 8 wt%, i.e. a TPGS:THC ratio of 3:8 (0.375:1), which is well below the claimed minimum of 1:1”; that “Table 1 demonstrates the practical THC concentration, as measured by HPLC analysis, in compositions that were diluted with water, forming an oil-in-water (O/W) emulsion”; that “Samples 5-7, in which the amount of vitamin E TPGS exceeds that of the cannabinoid, demonstrated a positive delta, meaning the measured THC concentration was higher than expected based on theoretical calculations”; that “there are several inaccuracies in the specification, in paragraph [0127], concerning the HLB value calculations” that “as may be seen, an increased practical concentration of THC was observed only when the HLB value was equal to or greater than 6.98, as in sample 5” and “sample 5 demonstrated the most pronounced effect, with the largest positive delta between the measured and theoretical cannabinoid concentrations”; that “increasing the content of vitamin E TPGS in the composition to 66.67% and 75% in samples 6 and 7…while leading to an increased HLB value…was actually found to reduce the delta”; that “these findings indicate that the relationship between Vitamin E TPGS level and the behavior of the cannabinoid in the self-emulsified system is not linear or predictable”; that “further increases of Vitamin E TPGS above 1:1 reduce the magnitude of the positive delta”; and that “formulations disclosed in US 2006/0257463 (samples 1-4) contain W/O emulsions, whereas emulsions disclosed in the present invention (samples 5-8) contain O/W emulsions”; and, moreover, “claims 19 and 20 correspond to Table 5 and paragraph [0172] of the Specification, which provide comparative plasma concentration data for the first six hours following administration of two sublingual tablets versus four sprays of Sativex…to further distinguish the claimed tablet/film form from alcohol-based spray prior art”.
The Examiner, however, would like to point out the following:
1. Elsohly is not limited to the specific examples. Elsohly is certainly not limited to a TPGS:THC ratio of 3:8 (0.375:1). Moreover, the prior art rejection is not over Elsohly alone. On the contrary, the prior art rejection is over Elsohly in view of Purcell. One of ordinary skill in the art, in view of the cited prior art, would arrive at the claimed TPGS:THC ratio of at least 1:1 for reasons discussed in the prior art rejection.
2. Claim 1 stipulates in a wherein clause that the claimed composition, upon dilution with water, forms an oil-in-water (O/W) emulsion. This is nothing more than a statement of an intended use or possible use for the claimed composition. The claimed composition itself is not the referenced oil-in-water emulsion. Rather, the claimed composition is merely one component in the referenced oil-in-water composition.
3. However, Table 1 describes a property of the oil-in-water emulsion, not the presently claimed composition itself. Put another way, Applicant is attempting to patent the claimed composition based on a property discovered and documented in another, non-claimed composition. In the United States, the claimed composition itself must be new and non-obvious to get a US patent for that composition. Whether or not another, non-claimed composition is somehow new and non-obvious is irrelevant, even if the claimed composition could be employed as a constituent element in the other, non-claimed composition.
4. Applicant’s finding that the magnitude of the positive delta is highest at the TPGS:THC ratio of 1:1, and that “further increases of Vitamin E TPGS above 1:1 reduce the magnitude of the positive delta” and thus “indicate that the relationship between Vitamin E TPGS level and the behavior of the cannabinoid in the self-emulsified system is not linear or predictable” is entirely meaningless with respect to the patentability of the claimed composition. Applicant’s claimed TPGS:THC weight ratio is “at least 1:1”. Hence, Applicant is merely comparing higher positive delta values within the claimed range with lower positive delta values within the claimed range, which is meaningless.
5. Claims 19 and 20 are not limited to a comparison with SATIVEX. Indeed, claims 19 and 20 say nothing at all about SATIVEX. Claims 19 and 20 are comparing undefined and unknown “plasma levels” with undefined and unknown plasma levels of an undefined and unknown “alcohol-based oral spray”. The comparison is meaningless.
For the foregoing reasons, the 35 USC 103 rejections are hereby maintained.
Conclusion
No claims are allowed.
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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 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, Sue Liu can be reached at 571-272-5539. 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.
/DAVID BROWE/Primary Examiner, Art Unit 1617
Prosecution Insights