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 Claims
The amendments and arguments filed on 07/13/2026 are acknowledged and have been fully considered. Claims 1-3, 45, 49, and 52-57 are now pending. Claims 4-44, 46-48, and 50-51 are canceled; claims 45 and 49 are withdrawn; claims 52 and 57 are amended.
Claims 1-3 and 52-57 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, and constitute the complete set presently being applied to the instant application.
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.
Claims 1-3 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20180214412 A1 (Renwick, 2018) in view of US PGPUB 20180147179 A1 (Raber, 2018) as evidenced by NPL3 (A review of disintegration mechanisms and measurement techniques, Markl et al., 2017).
In regards to claims 1-3, Renwick teaches an immediate release pharmaceutical composition comprising one or more cannabinoids and one or more pharmaceutically acceptable excipients (see Renwick, abstract). Renwick further teaches that the composition comprises granules comprising cannabidiol, dibasic calcium phosphate, lactose monohydrate (both calcium phosphate and lactose monohydrate are diluents (see Renwick, paragraphs 0071-0072)), pregelatinized modified starch, and hydroxyl ethyl cellulose (see Renwick, paragraphs 0025-0030). Renwick also teaches that the composition comprises an opiate such as morphine as an additional active (see Renwick, paragraph 0037).
Renwick is silent on the composition comprising particles between about 20µm and about 2000µm in diameter and the use of a poloxamer in the composition.
In regards to claim 1 and 57, Raber teaches a powder composition comprising cannabinoids and mixtures of pigments, emulsifiers, or odorants (see Raber, abstract). It is taught that emulsifier is a secondary coating substance of the particle (see Raber, paragraph 0038). The emulsifier is taught to be poloxamer 188 or various Lutrol® emulsifiers (i.e., poloxamers (see Raber, paragraph 0080). It is taught that the cannabinoid coating is first made into a powder which is then used to coat another powder (see Raber, paragraph 0081-0082). Further it is taught that the coating is homogenous over the other powder (see Raber, paragraphs 0034-0035) and as such, it would be understood by one with ordinary skill in the art that the coating itself would also be homogeneous in order to achieve a truly homogeneous coating. It is also taught that the preferred powder mesh size of the powder is from 1-100µm (see Raber, paragraphs 0075-0077). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claim 3, it is taught that the powder is based on cellulose-based polymers (i.e. cellulose derivatives) (see Raber, abstract).
In regards to claims 1-3 and 57, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Renwick and Raber to formulate an immediate release pharmaceutical composition comprising granules comprising cannabidiol, hydroxyl ethyl cellulose, poloxamer, and morphine wherein the granules have a powder mesh size of the powder is from 1-100µm as using smaller particle sizes allows for higher loads of agents, such as cannabinoids (see Raber, paragraph 0100). Further it is taught that the use of an emulsifier can enhance the absorption of the cannabinoids by the human body, can produce stronger effects such as physiological, medicinal, sensory (taste, smell, palatability), aesthetic, psychological, and any combination thereof, while also enhancing the homogeneity of the composition (see Raber, paragraph 0080). One with ordinary skill in the art would be motivated to combine the composition of Renwick with the teachings of Raber according to the making a drug formulation (see Renwick, paragraphs 0100-0105) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
MPEP 2112.01(I) states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” MPEP 2112.01(II) also states that “[p]roducts of identical chemical composition cannot have mutually exclusive properties” and that “[a] chemical composition and its properties are inseparable.” Regarding claim 1, more specifically to the limitation of “wherein the composition releases at least about 30% of the two or more actives over a period of about 30 minutes or less,” the Examiner submits that since the teachings of Renwick and Raber yield an identical immediate release composition as instantly claimed, the ordinarily skilled artisan would have a reasonable expectation of achieving the aforementioned properties.
Renwick also teaches dronabinol has an onset of action of approximately 0.5 to 1 hours after oral administration (see Renwick, paragraph 0006). Further in regards to the limitation, NPL3 teaches that an immediate release tablet (as the one taught by Renwick) is designed to fully disintegrate and dissolve within a short period of time upon exposure to physiological fluids (2.5 to 10 minutes) (see NLP3, page 891, column 1, paragraph 1).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20180214412 A1 (Renwick, 2018) in view of US PGPUB 20180147179 A1 (Raber, 2018) as evidenced by NPL3 (A review of disintegration mechanisms and measurement techniques, Markl et al., 2017) as applied to claims 1-3 and 57 above, and further in view of US PGPUB 20180243210 A1 (Coulter et al., 2018).
The teachings of Renwick and Raber have been described supra.
The teachings of Renwick and Raber are silent on the use of a surfactant selected from the polysorbates and polyethylene glycol esters of ricinoleic acid.
Coulter teaches a composition for treatment in the form of granules or powder (see Coulter et al., paragraph 0341) comprising a cannabinoid (see Coulter et al., paragraph 0131) and a combination of surfactants, including glycerol polyethylene glycol ricinoleate (see Coulter et al., paragraphs 0158-0159).
In regards to claim 52, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Renwick, Raber, and Coulter et al. to formulate an immediate release pharmaceutical composition comprising granules comprising cannabidiol, hydroxyl ethyl cellulose, morphine, and surfactants (i.e. glycerol polyethylene glycol ricinoleate and poloxamers) as it is known that surfactants are used to facilitate manufacturing and process of the composition (see Coulter et al., paragraph 0192). It would be obvious to one with ordinary skill in the art to combine the surfactant of Coulter et al with the composition of Renwick and Raber according to the making a drug formulation (see Renwick, paragraphs 0100-0105) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claim 53-56 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20180214412 A1 (Renwick, 2018) in view of US PGPUB 20180147179 A1 (Raber, 2018) as applied to claims 1-3 and 57 above, and further in view of WO 2017202424 A1 (Schou et al., 2017) and WO 2009007768 A1 (Thorengaard, 2009) as evidenced by NPL3 (A review of disintegration mechanisms and measurement techniques, Markl et al., 2017) and WO 2013006305 A1 (Firrell et al., 2013).
The teachings of Renwick and Raber have been described supra.
The teachings of Renwick and Raber are silent on the composition comprising a plurality of particles in which the particles comprise at least one cannabinoid, but not the non-cannabinoid therapeutic agent or comprise the non-cannabinoid therapeutic agent, but not the cannabinoid or particles that exclude the cannabinoid and non-cannabinoid therapeutic agent.
Schou teaches a powdered composition for immediate delivery of a cannabinoid (see Schou page 3, lines 1-11), such as THC, CBD, and CBN (see Schou, page 9, lines 30-31) in the form of a quick dissolving tablet or chewing gum (see Schou, page 19, lines 25-28).
Schou also teaches that the average particle size of the powdered composition is between 1 and 400µm with at least 75% of the particles having a particle size between 5 and 100µm (see Schou, page 18, lines 5-21).
Schou teaches that an antioxidant is used, such as tocopherol and its salts (i.e., vitamin E) (see Schou, paragraph bridging pages 39-40). Vitamins are taught as a non-cannabinoid therapeutic agent in the instant specification as filed (see paragraph 0027 of instant specification as filed).
Schou further teaches that the composition is in the form of a two-module chewing gum tablet, wherein the modules have different compositions (see Schou, page 72, lines 11-24).
Thorengaard teaches a tablet comprised of modules of compressed granules (see Thorengaard, page 13, lines 26-28) in the form of chewing gum (see Thorengaard, page 7, lines 26-29). Thorengaard teaches that the particles of the invention have a size of 200-2000µm (see Thorengaard, page 13, lines 5-16). Thorengaard teaches that if the active ingredient is a pharmaceutical active, it is advantageous to be comprised in a module substantially free of the gum base and if it is a taste relevant active it may be added in a module as separate particles that are compressed with gum base or incorporated into the gum-based granules (see Thorengaard, page 83, lines 14-24).
In regards to claims 53-56, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to use the teachings of Renwick, and Raber with the teachings of Schou and Thorengaard to formulate an immediate release composition in the form of a chewing gum with multiple modules. Firrell teaches that tocopherol with a fat (such as fatty acids, vegetable oils, among others (see Firrell, paragraph 0025) is used for taste masking, particularly for bitter tasting substances (see Firrell, abstract). These are also taught to be used in the compositions of Schou (see Schou, page 57, lines 8-12) and Thorengaard, especially for providing a smooth surface to the gum base (see Thorengaard, page 50, lines 8-30). Using the teachings of the prior art, one with ordinary skill in the art can envisage a composition as claimed. For example, an immediate release chewing gum with multiple modules with a module comprising particles of the cannabinoid (a pharmaceutical active) and a separate module with particles comprising tocopherol (i.e., vitamin E) with the gum base and particles without the tocopherol (i.e., particles excluding both the cannabinoid and the non-cannabinoid therapeutic). One with ordinary skill in the art would be motivated to combine the teachings of Renwick and Raber with the teachings of Schou and Thorengaard according to the known method of making a drug formulation (see Renwick, paragraphs 0100-0105) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claims 1-3 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20200163931 A1 (Dely, 2020; US PGPUB of WO 2018071581 A1 as submitted on IDS of 01/29/2020) in view of US PGPUB 20180147179 A1 (Raber, 2018) evidenced by NPL3 (A review of disintegration mechanisms and measurement techniques, Markl et al., 2017).
In regards to claims 1-3, Dely teaches an oral hard-fill formulation for the immediate release of cannabinoids (see Dely, paragraph 0011) comprising a cannabinoid in a powder form derived from a granulation utilizing microcrystalline cellulose as the carrier (see Dely, paragraph 0014). Further, the carrier comprises cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, starch, pregelatinized starch, dicalcium phosphate, tricalcium phosphate, and mixtures thereof (see Dely, paragraph 0026). Further, the granules are blended with sodium starch glycolate to form a powder blend which is encapsulated into a hard-shell capsule (see Dely, paragraph 0031).
Dely is silent on the composition comprising particles between about 20µm and about 2000µm in diameter, the use of a poloxamer, and the use of a non-cannabinoid therapeutic agent in the particles of the composition.
The teachings of Raber have been described supra. Raber further teaches that the composition comprises terpenes, such as vitamin A and vitamin K (see Raber, paragraphs 0008, 0032). Vitamins are taught as a non-cannabinoid therapeutic agent in the specification as filed (see instant specification, paragraph 0029).
In regards to claims 1-3 and 57, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Dely and Raber to formulate an oral hard-fill formulation for the immediate release of cannabinoids steroid (see Dely, paragraph 0011) and a vitamin comprising a cannabinoid in a powder form derived from a granulation utilizing microcrystalline cellulose as the carrier, wherein the granules have a powder mesh size of the powder is from 1-100µm as using smaller particle sizes allows for higher loads of agents, such as cannabinoids (see Raber, paragraph 0100). Further it is taught that the use of an emulsifier can enhance the absorption of the cannabinoids by the human body, can produce stronger effects such as physiological, medicinal, sensory (taste, smell, palatability), aesthetic, psychological, and any combination thereof, while also enhancing the homogeneity of the composition (see Raber, paragraph 0080). One with ordinary skill in the art would be motivated to combine the compositions of Dely and Raber according to the making a hard-fill formulation (see Dely, paragraph 0031) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
MPEP 2112.01(I) states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” MPEP 2112.01(II) also states that “[p]roducts of identical chemical composition cannot have mutually exclusive properties” and that “[a] chemical composition and its properties are inseparable.” Regarding claim 1, more specifically to the limitation of “wherein the composition releases at least about 30% of the two or more actives over a period of about 30 minutes or less,” the Examiner submits that since the teachings of Dely and Raber yield an identical immediate release composition as instantly claimed, the ordinarily skilled artisan would have a reasonable expectation of achieving the aforementioned properties.
Further in regards to the limitation, NPL3 teaches that an immediate release tablet (as the one taught by Dely) is designed to fully disintegrate and dissolve within a short period of time upon exposure to physiological fluids (2.5 to 10 minutes) (see NLP3, page 891, column 1, paragraph 1).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20200163931 A1 (Dely, 2020; US PGPUB of WO 2018071581 A1 as submitted on IDS of 01/29/2020) in view of US PGPUB 20180147179 A1 (Raber, 2018) as applied to claims 1-3 and 57 above, and further in view of US PGPUB 20180243210 A1 (Coulter et al., 2018) as evidenced by NPL3 (A review of disintegration mechanisms and measurement techniques, Markl et al., 2017).
The teachings of Dely and Raber have been described supra.
Dely and Raber are silent on the use of a surfactant selected from the polysorbates and polyethylene glycol esters of ricinoleic acid.
The teachings of Coulter et al. have been described supra. Coulter teaches that the composition comprises a cannabinoid and another steroid such as budesonide (see Coulter et al., paragraph 0131).
In regards to claim 52, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Dely, Raber, and Coulter et al. to formulate an oral hard-fill formulation for the immediate release of cannabinoids (see Dely, paragraph 0011) and another steroid comprising a cannabinoid in a powder form derived from a granulation utilizing microcrystalline cellulose as the carrier and ethanol or isopropanol and surfactants (i.e. glycerol polyethylene glycol ricinoleate and poloxamers) as it is known that surfactants are used to facilitate manufacturing and process of the composition (see Coulter et al., paragraph 0192). One with ordinary skill in the art would be motivated to combine the composition of Dely and Raber with the teachings of Coulter according to the making a hard-fill formulation (see Dely, paragraph 0031) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claims 53-56 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20200163931 A1 (Dely, 2020; US PGPUB of WO 2018071581 A1 as submitted on IDS of 01/29/2020) in view of US PGPUB 20180147179 A1 (Raber, 2018) and US PGPUB 20180243210 A1 (Coulter et al., 2018) as applied to claims 1-3, 52, and 57 above, and further in view of further in view of WO 2017202424 A1 (Schou et al., 2017) and WO 2009007768 A1 (Thorengaard, 2009) as evidenced by NPL3 (A review of disintegration mechanisms and measurement techniques, Markl et al., 2017) and WO 2013006305 A1 (Firrell et al., 2013).
The teachings of Dely, Raber, and Coulter have been described supra.
The teachings of Dely, Raber, Coulter are silent on the composition comprising a plurality of particles in which the particles comprise at least one cannabinoid, but not the non-cannabinoid therapeutic agent or comprise the non-cannabinoid therapeutic agent, but not the cannabinoid or particles that exclude the cannabinoid and non-cannabinoid therapeutic agent.
The teachings of Schou and Thorengaard are described supra.
In regards to claims 53-56, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to use the teachings of Dely, Raber, Coulter with the teachings of Schou and Thorengaard to formulate an immediate release composition in the form of a chewing gum with multiple modules. Firrell teaches that tocopherol with a fat (such as fatty acids, vegetable oils, among others (see Firrell, paragraph 0025) is used for taste masking, particularly for bitter tasting substances (see Firrell, abstract). These are also taught to be used in the compositions of Schou (see Schou, page 57, lines 8-12) and Thorengaard, especially for providing a smooth surface to the gum base (see Thorengaard, page 50, lines 8-30). Using the teachings of the prior art, one with ordinary skill in the art can envisage a composition as claimed. For example, an immediate release chewing gum with multiple modules with a module comprising particles of the cannabinoid (a pharmaceutical active) and a separate module with particles comprising tocopherol (i.e., vitamin E) with the gum base and particles without the tocopherol (i.e.; particles excluding both the cannabinoid and the non-cannabinoid therapeutic). One with ordinary skill in the art would be motivated to combine the teachings of Dely, Raber, Coulter with the teachings of Schou and Thorengaard according to the known method of making a drug formulation in a chewing gum (see Schou, example 7) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Response to Arguments
Applicant's arguments filed 07/13/2026 have been fully considered but they are not fully persuasive.
In regards to applicant’s argument that the art does not provide a basis for concluding that incorporating a poloxamer into Renwick’s formulation would preserve the formulation as an immediate-release formulation and that sodium lauryl sulfate is not an interchangeable surfactant, it is first noted that the rejection is not one based on substitution. There is no argument that the surfactant of Renwick is replaced with or substituted with the poloxamer of Raber, rather that it would be obvious to one with ordinary skill in the art to include the poloxamer as an emulsifier with known benefits as discussed in the rejection. There is no indication in the art that would leave one with ordinary skill in the art to assume that the immediate release nature of the composition would be affected as the components that are taught to affect it are still present (e.g., the surfactant as pointed out by applicant). Further MPEP 2112.01(I) states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” MPEP 2112.01(II) also states that “[p]roducts of identical chemical composition cannot have mutually exclusive properties” and that “[a] chemical composition and its properties are inseparable.” Regarding claim 1, more specifically to the limitation of “wherein the composition releases at least about 30% of the two or more actives over a period of about 30 minutes or less,” the Examiner submits that since the teachings of Renwick and Raber yield an identical immediate release composition as instantly claimed, the ordinarily skilled artisan would have a reasonable expectation of achieving the aforementioned properties.
Renwick also teaches dronabinol has an onset of action of approximately 0.5 to 1 hours after oral administration (see Renwick, paragraph 0006). Further in regards to the limitation, NPL3 teaches that an immediate release tablet (as the one taught by Renwick) is designed to fully disintegrate and dissolve within a short period of time upon exposure to physiological fluids (2.5 to 10 minutes) (see NLP3, page 891, column 1, paragraph 1).
With this in mind, there no reason why one with ordinary skill in the art would reasonably expect that the combination of Renwick and Raber would behave differently than the instant composition. As such the rejection is maintained.
In regards to applicant’s argument that the discussion of poloxamers in coating layers in Raber does not render intra-granule use of poloxamers obvious, it is pointed out again that there is nothing in the disclosure that would lend one with ordinary skill in the art to understand a coating not a part of the granule itself. Further applicant argues that poloxamer is an amphiphilic block copolymer, which is different than the sodium lauryl sulfate of Renwick (see Renwick, paragraph 0073), and that the rationale used in the rejection does not support the proposed combination. It is pointed out that poloxamer 188 and various Lutrol® are taught as emulsifiers (see Raber, paragraph 0080) and that emulsifiers are known to have a variety of benefits (see Raber, paragraph 0080). It would be within the purview of one with ordinary skill in the art to understand that poloxamer 188, which is taught as an emulsifier, would display at least one, if not all, of the benefits that are known in the art with a reasonable expectation of success. While there are no working examples, data, or formulation discussion in the art of the combination (as that would be anticipation of the instant invention), it is known that the emulsifiers of Raber have benefits as discussed, which give a motivation to combine the emulsifier of Raber with the composition of Renwick to yield a composition that has better absorption of the cannabinoids by the human body or produce a stronger effect, while also enhancing the homogeneity of the composition as taught in Raber (see Raber, paragraph 0080). All of this would also apply to the composition of Dely, as discussed in the rejections above.
As the applicant’s arguments have been rebutted, the rejections over all of the claims are maintained.
In regards to applicant’s arguments against Dely, the relevant arguments have been addressed above. However applicant further argues against Dely that Dely does not teach the use of surfactant at all and that the combination of Dely and Raber would be improper hindsight, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Further, the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the instant case, the benefits of using an emulsifier have been discussed and as such it would be within the purview of one with ordinary skill in the art to combine the teachings of Dely with Raber to formulate a composition with those known benefits with a reasonable expectation of success. While Raber is silent on the use of immediate release compositions, it would be within the purview of one with ordinary skill in the art to modify the teachings of Dely to incorporate an emulsifier, such as a poloxamer, into the immediate release composition it teaches.
As such, the rejections are maintained.
Double Patenting
Response to Arguments
The terminal disclaimer filed 07/13/2026 is sufficient to overcome the double patenting rejections and as such the rejections have been withdrawn.
Conclusion
No claims allowed.
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.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
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